Royed Training Catalogue 9.3

ONLINE
TRAINING
PHARMA | 24X7 LEARNING |
BIOPHARMA |
MEDICAL
SIMULATION BASED
DEVICES | REAL LIFE PRACTICAL
FMCG | FOOD TRAINING
GET SKILLED - GET CERTIFIED
Globally Since 2012
royed.in info@royed.in
Royed Course Features
Self Paced Learning - All Royed courses are online and distance mode.
One can attend the courses across the globe, anywhere.
Interactive e-lectures (audio-visual), simulations, assignments and final

examination can be accessed online across anywhere, anytime across the
globe across any devices like desktop, smartphones, ipad, net books etc.
From desktop to mobile,

learn across any devices!
Course certificates will be provided at the end of the course.

There are two certificates will be provided.
1. Course Completion Certificate [All who enrolled for the course gets
course complete certificate at the completion of the course duration]
2. Course Gradation Certificate [All those who successfully completes the
final certification exam, receive merit certificate]
Access real life case studies and live simulations from different domains
of pharmaceutical industry. It helps in developing real life competencies in
the field of the pharmaceuticals.
Online final examination (Computer Based Test by secure mode), can be

taken from any devices, from anywhere at own convenient time.
In this catalogue to search any course

or content, type "Ctrl+F", then type
keyword and search.
info@royed.in www.royed.in
About Royed Training www.royed.in
Royed Training is ISO 9001:2015 Certified Training Institute, dedicated to

growing and enhancing the professional standards in pharmaceutical,
biopharmaceutical, medical devices, Healthcare, Nutraceutical, FMCG,
Food industry.
ROYED is an independent training provider. Royed Training involved in providing
training, mentoring and coaching or consulting services. Royed offers online, onsite
and blended training courses to help professionals get certified and get professional
competencies. We provide online and onsite training for pharmaceutical,
biopharmaceutical, medical devices, food, fast moving consumer goods, nutraceutical
industry. www.royed.in offers online courses which are simulation based 24x7
learning. Hence, it provides convenience to students and professionals to attend the
lecture session at their own convenient time. All our courses provide holistic, easy and
quality tools to drive key learning initiatives.
Snapshot of Corporate Learning

We provide technical and skill enhancer training for
various functional departments.
Training is built on microlearning, which is ideal for
the corporate executives.
We have more than 450+ pre designed courses.
Royed Online Course Types
Corporate admin access (analytic dashboard) is
provided to track the candidate progress in the
course.
Courses are designed and customized based on 3 DAYS
MICROLEARNING
the need and suggestions from L&D / HR / functional CERTIFICATION
COURSE
department.
Employee self-service portal is available, where
employees can choose / even admin can allocate 1 WEEK PROGRAM CERTIFICATION
the desired course. PROGRAM
In pursuit of the above, we seek opportunities to
connect to your organization L&D department / 1 M O N T H P R O G R A M ADVANCE
concerned person who takes care of the training. CERTIFICATION
Any requirement, feel free to contact us, we will
be happy to assist you and your organization for
your next training need. 1 YEAR PROGRAM PG
CERTIFICATION
Our Esteemed Clients info@royed.in www.royed.in

Hands-on training for Biopharma Executives
RYD-093
BIOPHARMA GLOBAL MANAGEMENT

1 year Executive PG certification
Min 3 Years Experience in Middle to Top Management is mandatory.
Biopharma global business course provides hands-on training to enhance skill competency
of biopharma middle and top level managers. This course is ideal for the working
professionals of biopharmaceutical industry. This comprehensive biopharma global
management training involves the real life job simulation. Hence, the course provides
practical knowledge. Moreover, this course focuses on how biopharma business
development, strategic management, regulatory and licensing professionals work in the
company.
Therefore, it helps advance professionals to acquire
cutting edge business skills.
In these online self-paced modules, participants
understand about the development to
commercialization process in detail. In other words,
you will understand portfolio strategic management.
Hence, the course covers fundamentals to advance
learning on various skill areas for Biopharmaceutical
Business.
Advanced Biopharmaceutical Strategic Management Course
Market Sizing, Forecasting Biopharma Branding Digital

R&D Management Marketing
BD, Valuation
Market Access, Pricing, Project Biopharma
and
Reimbursement Management Regulations & MA
Licensing
Strategic Planning
RYD-080
PHARMA GLOBAL MANAGEMENT

Min 5 Years Experience in Middle to Top Management is mandatory.
Pharma global management course provides hands on training to enhance

skill competency of pharmaceutical middle and top level managers. This
course ideal for the working professionals of pharmaceutical and
biopharmaceutical industry. This comprehensive pharma global management
training involves the real life job simulation. Hence, the course provides
practical knowledge. Moreover, this course focuses on how pharma business
development, strategic management, regulatory and licensing professionals
working in the company. Therefore, it helps advance professionals to acquire
cutting edged business skills.
Course Coverage
Pharmaceutical Biopharmaceuticals
Course comprehensively covers biopharmaceutical strategic

management.
Feature of the course
1. This pharma global management covers all aspects of the strategic management from drug
discovery development, regulatory, commercialization, marketing, branding, business
development and sales. Hence the course provides
2. The course provides orientation to job related practical aspects of the business development
managers. Therefore, on completion of the course, the participants will develop the hands on
understanding how Business Development Professional works.
3. One of the important feature of the course is real life simulation on critical decision making
process. Hence, these simulations help to enhance the licensing and decision making skills
which is the core aspects of the pharmaceutical management working.
Drug Discovery, Development,

Advance R&D Management
Pharma Branding, Marketing

and advance strategic planning
International Business Development,

portfolio management, Licensing,
Brand Valuation, Deal Management
Plant certification, plant management,

registration dossier, export documentations.
Regional Business Development Strategies to manage

global business operation
USA Latam
Europe
Middle East Africa ASEAN China Japan India

Single comprehensive course covers Region Specific Pharma
Business Management !
RYD-077
DRUG BIOLOGICS MEDICAL

DEVICES REGULATORY AFFAIRS
This online drugs biologics medical devices regulatory affairs course provides understanding of
regulation, registration process and strategic planning. This PG Certification trains Regulatory
Affairs professionals for drug, biologic and medical devices Industry. This comprehensive drugs
biologics medical devices regulatory affairs training involves the real life job simulation. Hence, the
course provides practical knowledge. Moreover, this course focuses on how regulatory
professionals work in the company. Therefore, it helps users to understand the key responsibilities
and job functions.
Single comprehensive course covers all !
Drugs Biologics Medical Devices

1. Orientation to job related practical aspects of the drug regulatory managers, is covered in this
course extensively.
2. Simulation to real life working in regulatory affairs department. It help to enhance the
regulatory strategic decision making.
3. Advance training on drug registration requirements for various regulatory bodies.
4. Access to Case Studies to learn about the drug registration steps.
Course provides extensive training on country specific dossier

preparation, CTD, ACTD, DMF, ANDA Filing. Hands on training is provided
on ECTD, plant inspection, gmp audit, EIR, 483s, data integrity, data
exclusivity.
RYD-092
INTERNATIONAL DRUG
REGULATORY AFFAIRS
This online drugs biologics regulatory affairs course provides understanding of regulation,
registration process and strategic planning. This PG Certification trains Regulatory Affairs
professionals for pharmaceutical and biopharmaceutical industry.
This comprehensive drugs biologics regulatory affairs training involves the real life job simulation.
Hence, the course provides practical knowledge. Moreover, this course focuses on how regulatory
professionals work in the company. Therefore, it helps users to understand the key responsibilities
and job functions.
Most importantly, international drug regulatory affairs course covers

comprehensive training all regulatory regions like US, EU, GCC, MENA,
Middle East, CIS, African, ASEAN, Japan, Russia, China, India and Rest
of the World

1. Orientation to job related practical aspects of the drug regulatory managers, is covered in
this course extensively.
2. Simulation to real life working in regulatory affairs department. It help to enhance the
regulatory strategic decision making.
3. Advance training on drug registration requirements for various regulatory bodies.
4. Access to Case Studies to learn about the drug registration steps.

preparation, CTD, ACTD, DMF, ANDA Filing, IMPD, Investigator's
Brochure. Hands on training is provided on ECTD, plant inspection, GMP
audit, EIR, 483s, data integrity, data exclusivity.
Course only covers the drug and biologic regulatory affairs.

Medical Devices Regulatory Affairs is not covered in this course.
RYD-001
DRUG REGULATORY AFFAIRS

1 year PG certification
This online drug regulatory affairs course provides understanding of drug regulation, drug
registration process and strategic planning.
This PG Certification is designed to create effective Regulatory Affairs Manager for

Pharmaceutical Industry. This Drug Regulatory Affairs training course gives practical knowledge
and real life job simulation. Course focus on how regulatory professionals work in company and
understanding of key responsibilities and job functions.In this online self-paced modules,
participant will be understanding about the drug development to commercialization process in
detail. Stages of drug discovery and development, investigational new drug application, new drug
application, handling of different phases of clinical trial, generic drug approval process,
Abbreviated new drug applications will be covered in phased manner for easy understanding.
Course covers fundamental to advance learning on drug development, regulation, registration
and strategic management process.

1. Orientation to job related practical aspects of the drug
regulatory managers, is covered in this course extensively.
2. Simulation to real life working in regulatory affairs department.
It help to enhance the regulatory strategic decision making.
3. Advance training on drug registration requirements for various
regulatory bodies.
4. Access to Case Studies to learn about the drug registration
steps.
Course provides extensive training on country specific dossier preparation, CTD, ACTD, DMF,
ANDA Filing. Hands on training is provided on ECTD, plant inspection, EIR, 483s, data integrity,
data exclusivity.
This course covers entire general regulatory affairs. But regional regulatory
affairs is not part of this course. Both general and regional regulatory affairs
are covered under Executive Program in Drug Regulatory Affairs and
Executive Program in Drug Biologic and Medical Device Regulatory Affairs
course.
RYD-002
PHARMA SALES MANAGEMENT

The pharmaceutical sales management course is designed to

impart pharma selling skill training for pharma sales representatives
and managers.This is a PG certification course in pharmaceutical
sales management. This pharmaceutical sales training is ideal for
the pharma sales representative and pharma sales managers to
enhance pharma selling skills. Pharmaceutical sales Management
view Course
training course gives practical knowledge and real life job Content
simulation. Course objective is to focus on pharma selling skill
training for pharma sales representatives and for pharma sales
managers. This course covers daily job roles and responsibilities of
pharma sales professionals.

Job related practical training for the pharmaceutical
sales representative and managers.
Simulation to real life working in Pharma Sales. For
instance, daily work plan management by sales
representative and managers. The course is
designed on step on approach. Firstly focus on
pharma sales process and selling skills. Secondly,
on promotion management tools and techniques.
Thirdly on sales analysis skill training. For example,
sales forecasting tools and techniques, sales
performance review, incentive management etc.
Finally the focus on work knowledge enhance like
sales territory management, in-clinic performance
and soft skills for the pharma sales professionals.
Above all, this course is provided access to Case
Studies data bank. This is to enhance the strategic
planning and decision making skill.
Advance Selling Skill and Soft skill development

training is included.
WWW.ROYED.IN info@royed.in www.royed.in
This online training provides understanding of
RYD-003 pharma product management skills
techniques that are commonly applied in the
PHARAM PRODUCT
pharmaceutical and biotech industries.This
PG Certification is designed to create an
effective Brand Manager for the
MANAGEMENT Pharmaceutical Industry.
pharmaceutical product manager training
This
course gives practical knowledge and real life

1 year PG certification job simulation. Course focuses on how
product managers work in pharma companies
and understanding of key responsibilities and
job functions.
Pharma Marketing Plan Development, Marketing Campaign Preparation, Brand

Identify Creation, Trademarking, Technical Input designing - Visual Aid LBL Catch
Cover, Packaging Design, KOL Management, Advocacy Management, Conference
Management, Brand PR Management, Digital Marketing, Strategic Management,
Portfolio Management.

Orientation to job related practical aspects of the pharmaceutical
branding is covered in this courseSimulation to real life working in
Pharma Product Management Team (PMT).
Access to real life data bank of pharma promotional accelerating
material (PAM) - Visual Aids, Leave Behind Literature, Catch
Cover, Packaging designs, Reminder Card, etc.
Course covers comprehensive training on digital marketing tools
and techniques which are used in pharmaceutical industry.
Access to Case Studies and various pharmaceutical marketing
plans.
Digital marketing training for

pharma brand manager is included
in the course.
RYD-004
PHARMA MARKETING
The online pharma marketing course is designed to impart marketing skill training for brand,
marketing, and business development managers. This PG certification course provides
understanding on fundamental to advance understanding of pharmaceutical marketing
principle.This online pharma marketing training course is self paced. Therefore course can be
accessed 24x7 across anywhere.The unique interactive learning tools are used in this course to
guide each participant through the process of pharmaceutical marketing. In addition, the course
throws challenges students and professionals to apply what they have learned through the use
of interactive exercises, marketing simulation, reflection questions, expert live chat and a final
assessment at the end of the course. Most importantly these advance tools are very effective for
providing insight of pharma marketing skill. So that student can learn the concept effectively.

The course provide practical training on
common pharmaceutical marketing practices.
Therefore it helps the students to identify the
marketing tools and technique which commonly
used in pharmaceutical industry.
Simulation to real life working in pharma
management.Understanding Decision Making Course Coverage
and Strategy Creation in the field of pharma
Discovery, Development, Market Access,
marketing.
Commercialization
Above all, this course provide access to Online
Pharma Brand Management
Data bank of pharma marketing case studies
Strategic Planning
and real life marketing plans.
Business Development
Certainly, accessing these case studies can be
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helpful for students to understand various
Digital Marketing
strategies used in industry.
Sales Management
International Marketing
RYD-005
PHARMA STRATEGIC
BUSINESS MANAGEMENT
This online training provide understanding of pharma strategic business management skills which
are commonly applied in the pharma and biotech companies. The course is designed to create the
new-edged Strategic Business Manager for pharma and biotech industry. Course focuses on how
pharma and biotech strategic business manager works and their key responsibilities and job
functions.
Core Learning Area

Drug Development to Commercialization.
Innovation Management in pharmaceutical industry.
Pharma Marketing Strategic Planning.
Generic Drug Strategic Planning.Managing pharmaceutical SBU (strategic business unit)
revenue model.
Region specific pharma business strategies.International Marketing strategic planning in
pharmaceutical.
Deals and deal management in pharmaceutical and bio pharmaceutical industry.
Deal valuation tools and techniques.
Pharmaceutical Business Audit - Due diligence.
Financial Planning and Management for pharma strategic management professionals.Advance
soft skill training for pharma strategic management professionals.

Understanding on pharma strategic business management principles involved from drug
discovery development to commercialization. Therefore fundamental to advance R&D
management process training is included.
Additionally, the course provide pharma portfolio management skill training.Advance
Simulation provide to real life learning experience. Hence it helps to improve the decision
making skills of the participants.Biotech, biosimilar products strategic management is also part
of the course.
Above all, course participants are exposed to Global Pharma Business Case Studies.
RYD-006
MEDICAL DEVICES
REGULATION
The Medical Device Regulation Course is to impart knowledge and practical understanding
about the Regulation, Registration and approval process.This online course utilizes interactive
learning tools to guide each participant through the steps of medical devices regulation and
approval process in details. The course is designed to challenge students to apply what they
have learned through the use of interactive exercises, reflection questions, expert live chat
and a final assessment at the end of the course.The course can be completed at any pace,
allowing the user to stop and start at their leisure.

Advance understanding on medical device regulation across different regions, e.g. US,
EU, Canada, GCC, Middle East, ASEAN, LATAM, China, India etc.
Advance practical training in pre-market and post-market approval process.
Advance training on technical dossier preparation.Detailed training on ISO 13485 and CE
certification process.
Training on Medical device technical technical dossier preparation.
ECTD filing training is included.
RYD-084
PHARMA PRODUCTION AND

OPERATION MANAGEMENT
PG Certification in Pharmaceutical Production and operation Management is training on providing

pharmaceutical plant operation management. Therefore, this course provides extensive training
for executives and managers working in pharmaceutical plant. Hence, the objective of this course
is to provide practical knowledge of the functionalities of production related jobs and decision
making skills. Most importantly, this course provides 360 degree learning in all essential aspects
of drugs, quality, regulatory, manufacturing, management, export business management. In
conclusion, this online course covers all important areas what a pharmaceutical production
professionals requires exposure.

This online certification course provides comprehensive study
material covering all important aspects of Pharmaceutical
Production and operation management.
One of the major distinguishing features of this course is the
industry database of SOPs. This Pharmaceutical Production
management course provides 300s fully developed SOPs
covering different pharmaceutical production plant
management activities.
The course provides access to specialized modules covering
all Pharmaceutical Dosage Forms.
Most importantly, the course covers specialized modules on
GMP, ISO guidelines as well as handling of GMP and ISO
audits. Moreover, this course comes with exclusive hands-on
training on plant inspections and audits. Various issues like
483, regulatory queries handling and data integrity are covered
in this course.
Above all, the course covers the special modules on
Production related regulatory affairs. It covers dossier
preparation, filing requirements and export management
procedure for better understanding.
RYD-084
MEDICAL DEVICE
GLOBAL BUSINESS
Medical Device Global Business training course provides hands on training of medical devices
discovery to commercialization process.
This Executive PG certification course in Medical Devices covers medical devices strategic
management and planning process. Hence, this course will demonstrate medical devices business
skills and concepts. Most importantly, The course provides cased based learning. As a result, it helps
participants to understand the medical device discovery to commercialization process. Moreover,
cutting edge simulations help participants to understand medical device business development tools
and techniques.

Advance practical training in premarket approval
Discovery, development to commercialization.
process.
Advance training on technical dossier preparation.
Marketing Authorization Detailed training on ISO 13485 and CE
Strategic Planning certification process.
Training on Medical device technical dossier
EU, US, GCC, Middle preparation.
East, CIS, Africa, ASEAN, Medical Devices marketing and brand
BRIC, LATAM, management skill training.
Practical training on artwork development.
Core Medical Device Medical Device portfolio management and
Brand planning.
Learning Management Understanding on medical device export
Areas documentation.
Medical Device business development and
licensing training.
Region specific Advance understanding on medical device
medical device business development requirements across
business different regions, e.g. US, EU, Canada, GCC,
development ASEAN, LATAM, China, India etc.
Financial management for medical device
Advertising, company.
Promotion, Brand valuation.
Marketing, Digital Medical devices digital marketing training.
Marketing
RYD-084
PHARMA BUSINESS
DEVELOPMENT & LICENSING
Pharma Business Development and Licensing course is designed to train the practical working
knowledge and skill-set of Business Development. This course provides comprehensive skill training
for business development managers working in pharmaceutical and biopharmaceutical industry.
Pharma BD course covers important areas of the skill areas where a pharma business development
manager should have the competency.
In these online self-paced modules, participants understands about the development to
commercialization process in detail. In other words, you will understand portfolio strategic
management. Moreover, this course focuses on how pharma business development, strategic
management, regulatory and licensing professionals working in the company. Therefore, it helps
advance professionals to acquire cutting edged business skills. Hence, the course covers
fundamentals to advance learning on pharma business development process.

1. Drug Development to Commercialization - R&D Process, New Drug Development, Key understanding on New Drug & Generic Drug launching process, Clinical trials, Fundamental
understanding on clinical trial terminologies, Various strategic planning for clinical development. Handling of patent and exclusivity
2. Portfolio Management Training| Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process |
Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
3. Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis
| Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentiality - CDA | MTA
4. Life cycle extension / Loss of Exclusivity - LOE strategies.
5. Pharma Marketing and branding Strategic Planning.
6. Strategic Pathways for marketing authorization of the pharmaceutical and - biopharmaceutical products.
7. Exclusive training in turn-key project management.
8. In depth training on Licensing in pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion. Hands on training on
Licensing drafting.
9. Financial Planning and Management for pharma strategic management professionals
10. Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal
Structuring Structuring the deal
11. Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual
Royalties | Reach through royalties
12. Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses.
13. Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process.
14. Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach.EBITDA method of valuation |
Enterprise Value and Enterprise Multiple Calculation
15. In Depth practical marketing orientation for the pharma marketing professionals, Market Research, Consumer Behaviour and Brand Adoption Process, Product Lifecycle Management,
Segmentation, Targeting and Positioning, Pricing, Logistics, Distribution Channel Management, Promotion management process, Setting and quantifying Promotional objectives,
promotional budget setting - tools and techniques. Brand recall, brand recognition, top of mind recall.
16. Analytics - MAT, CAGR calculation, Brand potential development, RCPA, market size determination, Sales forecasting.
RYD-091
PHARMA INTERNATIONAL BUSINESS

DEVELOPMENT AND LICENSING [MENA
REGION]
Course covers International Business Development Training specific to MENA region.

Pharma International Business Development & Licensing training focus on international
business requirements in MENA region. Middle East and North Africa is witnessing good growth
in recent time. Consisting of approximately 22 countries and with over 350 million inhabitants,
the MENA pharmaceutical market was worth $36 billion in 2016, which represented 2% of the
global market. This relatively low starting base is now seeing projected growth of 10%, vastly
outstripping the current global growth rate of 4-6% – even surpassing the traditional
“pharmemerging” economies such as Brazil and China.
This course purely provides hands on training to enhance skill competency of pharmaceutical
middle and top level managers working on the MENA business region.
This course provides on how pharma business development, strategic management, regulatory
and licensing professionals working in the company. Therefore, it helps advance professionals
to acquire cutting edged business skills.
In these online self-paced modules, participants understands about the development to
commercialization process in detail. In other words, you will understand portfolio strategic
management. Hence, the course covers fundamentals to advance learning on various skill
areas.
Case Based Learning

Advance training on strategic management based on the various business regions.
Course covers regional business development requirements specific to MENA region.
Access to Case Studies to learn about the drug commercialization steps. Hence, participants
will develop advanced competency on strategic portfolio management.
RYD-099 RYD-089
PHARMA MARKET PHARMA MARKET

ACCESS ACCESS & PRICING
1 Year PG Certification 1 month advanced certification
This course will provide practical understanding about the pharma market access strategies,
forecasting, pricing and reimbursement. This advanced online market access and pricing course
covers pharmaceutical and biopharmaceutical market access strategic management and planning
process. Hence, this course will demonstrate market access skills required for pharmaceutical and
biopharmaceutical organization to success. The course provides real life case based simulations
for better understanding the complex issues of market access, pricing, forecasting. As a result, it
is easy for participants to understand the concepts. Moreover, cutting edge simulations help
participants apply the knowledge in interactive real life simulation.
Above all, this market access training course focus on value pricing for market access which is
important critical yet complex buzzword in biopharmaceutical industry. Also at the same time,
course provides in-depth understanding on evidence-based pricing for pharmaceuticals.

The course provided comprehensive
Market Assessment
advanced understanding on global and
Planning
national pricing, market access,
pricing, forecasting. Market Access,
Advance practical training in health Pricing Strategy
economics and evidence based pricing
Reimbursement,
concepts.
rebate, formulary
Advance training on market
placement
assessment to determine pricing
models. Commercialization
Detailed training on forecasting models strategy
and techniques with practical case
studies. Market Sizing,
Training on value dossier preparation. Forecasting Model,
Valuation Model
RYD-011
EU DRUG REGULATORY
AFFAIRS
1 month advance certification
The objective of European (EU) Drug Regulatory Affairs course is to provide training on Drug
Regulatory Affairs and approval process in European Union (EU).EU regulatory affairs course
covers recent pharmaceutical regulations, marketing authorization procedure, country specific
Common Technical Documents requirement. Moreover, comprehensive idea is provided how to
prepare drug dossier as per EU CTD format. Moreover course focuses on the various marketing
authorization pathways. Above all, course briefs on strategic planning for registration of
pharmaceutical, biopharmaceutical in European Union.
This online course utilizes interactive learning tools to guide each participant through to understand
of the EU regulatory structure and ensure that your submissions meet the standards required by the
regulators. The course will focus on understanding the European legal & regulatory environment;
the registration procedures that are available, and the structure of the registration dossier. The
course will adopt a practical and interactive approach that will enable you to apply what you have
learned to your daily work.the steps of approval process in details.

Orientation to practical understanding in the entire drug regulation,
registration procedure, data exclusivity.
Moreover, course also focus on Common Technical Documents,
guidelines and drug dossier preparations. Moreover, course explains
various marketing authorization strategic pathways.
This helps to enhance the regulatory strategic decision making skill.The
course extensively covers marketing authorization requirements for full
application, verification pathway and abridged pathway.
Hence, the course will nurture the regulatory strategic decision making
skills.Moreover, this training covers variations and renewals of
marketing authorization specific to pharmaceutical registration in
Japan.
This training program has advance sessions on CMC preparation,
Stability Study, Drug Master File Preparation, Site Master File
Preparation, Good Manufacturing Practices modules.
RYD-075
JAPAN DRUG REGULATORY

AFFAIRS
Japan drug regulatory affairs course provides training on marketing
authorization process and strategic planning in Japan. The course
provide detail training on drug Registration Procedure in Japan. It view Course
covers recent regulations, marketing authorization procedure,
country specific Common Technical Documents, guidelines and
Content
dossier preparation. Moreover course focus on the regulatory
affairs strategic planning for marketing authorization for different
class of pharmaceutical, biopharmaceutical in Japan.
The course is an essential source of information and analysis on

the healthcare, regulatory and reimbursement landscape in Japan.
Moreover the course identifies the key trends in regulatory,
reimbursement landscape and healthcare infrastructure of Japan.
Most importantly, the course provides valuable insights advance
regulatory strategic planning for successful product registration in
Japan.

registration procedure of Japan.
guidelines and drug dossier preparations. Moreover, course explains
various marketing authorization strategic pathways.
Hence, the course will nurture the regulatory strategic decision making
skills.Moreover, this training covers variations and renewals of marketing
authorization specific to pharmaceutical registration in Japan.
RYD-068
BRAZIL DRUG REGULATORY

AFFAIRS
This pharmaceutical regulatory affairs course "Brazil Pharmaceutical
Regulatory Affairs" provides training on marketing authorization
process in Brazil. The course provide detail training on marketing view Course
authorization Procedure in Brazil. It covers recent regulations,
marketing authorization procedure, country specific Common
Content
Technical Documents, guidelines and dossier preparation. Moreover
course focus on the regulatory affairs strategic planning for marketing
authorization for different class of pharmaceutical, biopharmaceutical
in Brazil. Hence, this course is vastly useful for those who want to
know or already working in RA. This course will help them to enhance
competency to handle Brazil pharmaceutical Marketing Authorization
Application (MAA) effectively.The course is designed to challenge
students and Professionals to apply what they have learned through
the use of interactive exercises, reflection questions, and a final
assessment at the end of the course..

registration procedure of Brazil. Moreover, course also focus on
Common Technical Documents, guidelines and drug dossier
preparations.
Moreover, course explains various marketing authorization strategic
pathways.
RYD-067
PHARMACEUTICAL
REGULATORY AFFAIRS IN
AFRICA
Pharmaceutical Regulatory Affairs in Africa trains the candidate on
view Course
pharmaceutical marketing authorization and regulatory procedures in
African countries. The course provide detail training on Regulations, Content
Registration procedure, guidelines and dossier preparation specific to
african countries. Moreover course focus on the regulatory affairs
strategic planning for registration of pharmaceutical, biopharmaceutical
in african countries.This advance certification course in
Pharmaceutical Regulatory Affairs covers drug registration, regulation
and marketing authorization strategic planning for all African countries
like Nigeria, Egypt, South Africa, Zmbia, Algeria, etc.
In addition, this course is designed to challenge students and
Professionals to apply what they have learned through the use of
interactive exercises, reflection questions, and a final assessment at
the end of the course.The course can be completed at any place. So, it
allows the user to stop and start at their lei
Gain an overview of the regulatory environment in the Africa

Insight on the pharmaceutical markets in Africa
Understand the strategic pathway for marketing authorization in African
countries
Harmonization and recent developments in the African region
Course provides extensive training on country specific

dossier preparation, CTD, ACTD, DMF, ANDA Filing.
Hands on training is provided on ECTD, plant inspection,
EIR, 483s, data integrity, data exclusivity.
RYD-066
MIDDLE EAST DRUG

REGULATORY AFFAIRS
The objective MIDDLE EAST Drug Regulatory Affairs is to impart
knowledge of drug regulatory procedures in MIDDLE EAST countries.
The course provide detail training on Regulations, Registration
view Course
procedure, guidelines and dossier preparation specific to MIDDLE
EAST countries. Moreover course focus on the regulatory affairs Content
strategic planning for registration of pharmaceutical, biopharmaceutical
in MIDDLE EAST countries.
This advance certification course in Middle East Regulatory Affairs
covers drug registration, regulation and marketing authorization
strategic planning for Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait,
Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria,
UAE and Yemen.

Gain an overview of the regulatory environment in the Middle East
Understand the Economic and cultural background to the Markets
Understand the strategic pathway for marketing authorization in middle east countries
Harmonisation and recent developments in the region - Centralised registration in the
Gulf (GCC-DR), Middle East Regulatory Conference (MERC)
RYD-065
DRUG REGISTRATION AND

REGULATION IN SAUDI ARABIA
This drug regulatory affairs course "Drug Registration and Regulation
in Saudi Arabia" provides training on marketing authorization process
in Saudi Arabia. The course provide detail training on drug
view Course
Registration Procedure in Saudi Arabia. It covers recent regulations,
marketing authorization procedure, country specific Common Content
course focus on the regulatory affairs strategic planning for marketing
authorization for different class of pharmaceutical, biopharmaceutical
in Saudi Arabia.
Hence, this course is vastly useful for those who want to know or
already working in regulatory affairs. This course will help them to
enhance competency to handle Saudi Arabia Marketing Authorization
Application effectively.

registration procedure of Saudi Arabia.
guidelines and drug dossier preparations. Moreover, course
explains various marketing authorization strategic pathways.
This helps to enhance the regulatory strategic decision making
skill.The course extensively covers marketing authorization
requirements for full application, verification pathway and abridged
pathway.
Hence, the course will nurture the regulatory strategic decision
making skills.Moreover, this training covers variations and renewals
of marketing authorization specific to pharmaceutical registration in
Saudi Arabia.
Course also provides hands on training on ECTD.
RYD-031

REGULATION IN UAE
This drug regulatory affairs course on "Drug Registration and
Regulation in UAE" provides deep insight on the marketing
authorization process in UAE. The course provide detail training on
view Course
drug Registration Procedure in United Arab Emirates. It covers recent
regulations, registration procedure, country specific Common Content
course focus on the regulatory affairs strategic planning for registration
of pharmaceutical, biopharmaceutical in United Arab Emirates.The
course is designed to challenge students and Professionals to apply
what they have learned through the use of interactive exercises,
reflection questions, and a final assessment at the end of the course.

registration procedure of UAE.
guidelines and drug dossier preparations. Moreover, course
explains various marketing authorization strategic pathways.
This helps to enhance the regulatory strategic decision making
skill.The course extensively covers marketing authorization
requirements for full application, verification pathway and abridged
pathway.
Hence, the course will nurture the regulatory strategic decision
making skills.Moreover, this training covers variations and renewals
of marketing authorization specific to pharmaceutical registration in
UAE.
Course also provides hands on training on ECTD.
RYD-060

REGULATION IN CHINA
This self paced online certification course on Drug Registration and
Regulation in China provides deep insight on the drug registration
process in China. How pharmaceuticals and biopahrmaceuticals
view Course
should be registered in China. Detailed understanding is provided new
and updated pharmaceutical regulatory system (post 2015) of China. Content
Hence, this China drug regulatory affairs course is designed to provide
extensive training for professionals who are handling drug registration
and marketing of pharmaceutical and bio-pharmaceuticals for China.In
2015, China’s pharmaceutical sector is undergone with the significant
regulatory reform. Therefore, regulatory approval process has
changed a lot. The regulatory reform had taken place keeping easy of
marketing authorization. While all effort is provided to realign the
regulatory pathway with developed market like US and EU.So, focus of
the course will be on strategic pathway for registering new drugs, Course covers
generic drugs, and also imported drugs which are not manufactured in China's new
china. Moreover, special emphasis is given on advance drug dossier
guideline, 2018.
development training. So, that one can create the submission dossier
effectively.

This China Drug Regulatory Affairs online course utilizes interactive
learning tools to guide each participant through to understand of the
regulatory process of the china pharmaceutical market.
This online certification course will focus on understanding regulatory affairs
strategic management skills which is required for effective functioning as
regulatory personnel. Indeed, advance simulation in the course will
challenge students to apply what they have learned from the course.
In addition, there are advance learning tools like interactive exercises,
reflection questions, expert live chat which makes the course very
interesting.
Course provides extensive training on dossier preparation, CTD, ACTD,

DMF, ANDA Filing. Hands on training is provided on ECTD, plant inspection,
gmp audit, EIR, 483s, data integrity, data exclusivity.
RYD-060
LATAM DRUG REGULATORY

AFFAIRS
The objective of this course is to impart knowledge and understanding
of Drug Registration Procedure in Latam countries, Regulations,
Registration procedure, country specific Common Technical
view Course
Documents, LATAM guidelines and dossier preparation.This online
course utilizes interactive learning tools to guide each participant Content
through the steps of drug regulation and registration process for the
LATAM countries. The course is designed to challenge students and
interactive exercises, reflection questions, expert live chat and a final
assessment at the end of the course.
This LATAM Drug Regulatory Affairs online course utilizes

interactive learning tools to guide each participant through to
understand of the regulatory process of the LATAM countries.
This online certification course will focus on understanding
regulatory affairs strategic management skills which is required for
effective functioning as regulatory personnel.
The course provide extensive training on dossier preparation and
submission. ECTD filing training is included in the course.
In addition, there are advance learning tools like interactive
exercises, reflection questions, expert live chat which makes the
course very interesting.

preparation, CTD, ACTD, DMF, ANDA Filing. Hands on training is
provided on ECTD, plant inspection, gmp audit, EIR, 483s, data
integrity, data exclusivity.
RYD-041
USFDA PHARMACEUTICAL AND

BIOPHARMACEUTICAL
REGULATION
view Course
The US regulatory affairs certification training course is to train
pharmaceutical, biopharmaceutical regulatory approval process in US. Content
The course provide comprehensive training on fundamental regulatory
topics. For example, understanding about investigational new drug,
and biologics development and approval process, submission dossier
preparation, filing steps etc. Moreover, upon completion of the
fundamental section, you will move to the next level which is advance
strategic planning on portfolio management. Hence, this course is
ideal for the effective training of Regulatory Affairs personnel. Above
all, this US Regulatory Affairs training course gives practical
knowledge and real life job simulation. Course focus on how regulatory
professionals work in company and understanding of key
responsibilities and job functions.
This Drug Regulatory Affairs online course utilizes interactive

learning tools to guide each participant through to understand
of the regulatory approval by USFDA.
regulatory affairs strategic management skills which is required
for effective functioning as regulatory personnel.
Indeed, advance simulation in the course will challenge
students to apply what they have learned from the course.
In addition, there are advance hands on training on CTD and
eCTD filing.
RYD-012
GCC DRUG REGULATORY

AFFAIRS
The objective GCC Drug Regulatory Affairs is to impart knowledge of

drug regulatory procedures in GCC countries. The course provide
detail training on Regulations, Registration procedure, guidelines and view Course
dossier preparation specific to GCC countries. Moreover course focus Content
on the regulatory affairs strategic planning for registration of
pharmaceutical, biopharmaceutical in GCC countries.
In addition, this course is designed to challenge students and

interactive exercises, reflection questions, and a final assessment at
the end of the course.

preparation, CTD, ACTD, DMF, ANDA Filing. Hands on training is
provided on ECTD, plant inspection, gmp audit, EIR, 483s, data
integrity, data exclusivity.

This Drug Regulatory Affairs online course utilizes interactive
learning tools to guide each participant through to understand
of the marketing authorization process in GCC countries.
regulatory affairs strategic management skills which is required
for effective functioning as regulatory personnel.
Indeed, advance simulation in the course will challenge
students to apply what they have learned from the course.
In addition, there are advance hands on training on CTD and
eCTD filing.
RYD-013
PHARMACEUTICAL
INTERNATIONAL BUSINESS
MANAGEMENT
view Course
This online Pharmaceutical International Business Management
course provides an understanding of international business Content
requirement of pharmaceuticals. Advance Certification is designed to
create effective Pharmaceutical International Business Manager for
Pharmaceutical and Biopharmaceutical Industry. Pharma International
Business Manager's training gives practical knowledge and real-life job
simulation. Course focuses on how international marketing
professionals work in the company and understanding of key
responsibilities and job functions.This is a real-life learning course
which is specially prepared and designed not only for beginners but
also for those who are currently engaged in the activities of import &
export but are not too conversant with their international business
requirements for pharmaceuticals.

The course trains the candidate on skill set required pre-
registration, registration and post registration business
development and management process effectively. Moreover,
Course covers fundamental to advance learning on drug
registration process, regulation, and strategic management
process for effective decision making. Above all, this course
features pharmaceutical export business documentation process.
International Branding
Regulatory
and marketing
Business Development & Licensing
RYD-078
BIOPHARMACEUTICAL
PROJECT MANAGEMENT
This course provides training on the biopharmaceutical R&D
discovery, development and commercialization pipeline, project and
portfolio management. This online Pharmaceutical and view Course
Biopharmaceutical Project Management training course utilizes
interactive learning tools to guide each participant through the steps of
Content
the project management process which takes place in the
pharmaceutical, biotech keeping in view both in innovative and generic
industry.
Biopharma basic and training on various biopharmaceutical classes

Biopharma Regulation and Registration
Portfolio Management
Strategic planning
Skill training for project management
Detailed understanding in biologic discovery - development to commercialization project
management process.
Strategic look into biopharmaceutical R&D project management in pharmaceutical and
biopharmaceutical industry.
Biopharmaceutical Project Manager's Skill training - Introduction to Project Management,
Beginning a Project, Project Planning, Project Budgeting, Project Scheduling, Project
Execution, Monitoring and Controlling the Project, Summary of Project Management
Knowledge, Tools To Help Make a Project Manager Succeed.
Financial knowledge for biopharmaceutical industry. Advance training on licensing, advance
portfolio management, benchmarking, royalty management.
Valuation and deal management
Project Execution.
Customized formats, charts, logs for detailed project management systems and controls.
Practical Training on documentation.Handling of IT system and Project software.
RYD-079
BIOPHARMA MEDICAL
REPRESENTATIVES SELLING
SKILL DEVELOPMENT
view Course
The Biopharma medical representative training course is designed to
impart basic biologics selling skill training for medical Content
representatives.
This is competency development online certification course for medical
sales representatives. This pharma selling skill training is ideal for the
biologic sales representatives to enhance selling skills. Biopharma medical
representative training course gives practical knowledge and real life job
simulation. Course objective is to focus on specific biopharma selling skill
training for those working with the biopharmaceutical companies in sales
department. The course is unique blend of the two aspects. First of all, it
covers the biopharmaceutical industry and detailed understanding on the
various class of the biopharmaceuticals. Secondly, the course covers daily
job role and responsibilities of medical representative. Orientation to job
related practical aspects covers in this biopharmaceutical medical
representative selling skill training.

Job related practical training for the biopharma sales representative.
Simulation to real life working in Biologic Sales. For instance, how to plan a day working by
medical representatives.
The course is designed on step on approach. Firstly focus on pharma sales process and
selling skills. Secondly, how to handle the promotion management tools and techniques.
Thirdly, advance training is provided on sales reporting and administration requirements which
medical representatives need to carry out effectively. For example, daily reporting, monthly tour
planning, Joint working report, monthly sales analysis report, primary vs. secondary trend
analysis etc. Finally the focus on work knowledge enhance like sales territory management, in-
clinic performance and soft skills for the pharmaceutical medical representative.
RYD-047
PHARMACEUTICAL PROJECT
MANAGEMENT
This course provides training on the pharmaceutical R&D discovery,
development and commercialization pipeline, project and portfolio
management. This online pharmaceutical Project Management training view Course
course utilizes interactive learning tools to guide each participant
through the steps of the project management process which takes
Content
place in the pharmaceutical keeping in view both in innovative and
generic industry.
Portfolio Management
Strategic planning
Skill training for project management

Detailed understanding in drug discovery - development to commercialization project
management process.
Strategic look into R&D project management in pharmaceutical and biopharmaceutical
industry.
Pharmaceutical Project Manager's Skill training - Introduction to Project Management,
Beginning a Project, Project Planning, Project Budgeting, Project Scheduling, Project
Execution, Monitoring and Controlling the Project, Summary of Project Management
Knowledge, Tools To Help Make a Project Manager Succeed.
Financial knowledge for pharmaceutical industry. Advance training on licensing, advance
portfolio management, benchmarking, royalty management.
Valuation and deal management
Project Execution.
Customized formats, charts, logs for detailed project management systems and controls.
Practical Training on documentation.Handling of IT system and Project software.
RYD-048
PHARMACOVIGILANCE AND
DRUG SAFETY
The Overview of Pharmacovigilance & Drug Safety course gives you a
good understanding of the basic principles of pharmacovigilance – the
course covers the history of pharmacovigilance & drug safety, key
view Course
components within adverse event reporting in the clinical and post-
marketing settings and an overview of signal detection & risk Content
management.Keeping products on the market without interruption
becomes more essential with the reduced pipeline of drugs in
development. Successful navigation of drug safety and
pharmacovigilance are keys to product longevity, consumer
confidence and regulatory compliance. This module will provide you
with a strong foundation of knowledge on pharmacovigilance and drug
safety.
Core Learning Area

Introduction to Clinical Research and Pharmacovigilance
Global Pharmacovigilance System
Sources and Documentation of Individual Case Safety Reports
(ICSRs)
Case processing and Reporting
Medical dictionary (MedDRA) and Medical aspects in
Pharmacovigilance
Special cases in Pharmacovigilance• Medical Information
System
Safety monitoring in Clinical Trials
Signal detection
Periodic Safety Update Reports (PSURs)
Risk-benefit assessment and management in
Pharmacovigilance
Standard operating procedures in Pharmacovigilance
Compliance monitoring and Pharmacovigilance inspections
Global regulatory requirements and guidelines in
Pharmacovigilance
Pharmacovigilance communications
Pharmacoepidemiology
RYD-059
BIOPHARMA BUSINESS
DEVELOPMENT
Biopharma Business Development course is designed to train the
practical working knowledge and skill-set of Business Development job
in biopharma companies. This course provides comprehensive skill
view Course
training for business development managers working in
pharmaceutical and biopharmaceutical industry.This biopharma Content
business development course utilizes interactive learning tools to
guide participant to understand of the Business Development working
in a biopharma company.
The course will focus on understanding business development skills

which is required for effective functioning as BD personnel in business
development department. The course will adopt a practical and
interactive approach that will enable you to apply what you have
learned to your daily work.the steps of approval process in details. The
course is designed to challenge students to apply what they have
learned through the use of interactive exercises, reflection questions,
simulation and a final assessment at the end of the course.

This course provides comprehensive training on how to nurture and
manage BD deals step by step.
licensing (in and out licensing) and various types of BD deals in
pharmaceutical and biopharmaceutical companies.
Business Development case studies, simulation to enhance the
decision making skills.
Training on contract drafting and licensing agreement preparation.
Advance training on soft skills for the business development
professionals.
Hands on training on digital pharma business development tools
which are predominantly used by pharmaceutical and
biopharmaceutical companies.
RYD-015
DRUG DISCOVERY
DEVELOPMENT &
COMMERCIALIZATION
This online drug discovery, development and commercialization view Course
training course focus on drug development to market
commercialization process. The course provides orientation to Content
practical understanding in the entire drug development process. Learn
how to manage each steps of the drug development stages effectively.
Further, course provide extensive training on clinical trials which is key
for the approval of the drug. Fourthly, training includes regulatory
pathways for approval. What exactly the requirement from regulatory
agency for approving the drug. Lastly, this online training focuses on
the market commercialization process. How to launch the drug into the
market. And post marketing phase is explained in the course with
interactive exercises.

The Drug Development Process Regulatory Environment.
Training on Stages in the Drug Development Process – the second module provides a
detailed overview of the drug development process, taking a look at the life cycle, history,
timelines and phases critical to the process. The module covers the product discovery and
clinical testing steps essential to the early stages of the drug development process. After
that, course provides detailed understanding on the activities needed for regulatory
approval, manufacturing scale-up and post-market issues such as adverse event
monitoring or reporting and patent exclusivity.
Preclinical Steps in Drug Development -Training on the preclinical studies (studies in
animal subjects). Topic includes preclinical pharmacology, pharmacokinetic, GLP
compliance and more.
Clinical Steps in Drug Development -This covers what happens after discovering an NCE,
conducting preclinical trials and completing the IND/CTA application. Attendees will learn
the different phases of these clinical studies and about the NDA/MAA application.
Launching and marketing of Innovative Branded Drug - marketing planning, strategic
initiative, usage of clinical trial in marketing, Product Life cycle Management, forward and
backward integration for the branded pharmaceuticals for managing high ROI.
RYD-082
US MEDICAL DEVICES
REGULATORY AFFAIRS
(ACUSMDR)
The US Medical Device Regulation Course is to impart knowledge and view Course
practical understanding about the Regulation, Registration and
approval process in United States. This advanced certification course Content
in Medical Devices also covers medical devices strategic management
and planning process. Hence, this course will demonstrate medical
devices business skills and concepts. The course provides cased
based learning. As a result, it is easy for participants to understand the
concepts. Moreover, cutting edge simulations help participants apply
the knowledge in interactive real life simulation.

The course provided comprehensive
advanced understanding on US medical
device regulation.
Advance practical training in 510k
notification, premarket approval process.
Medical Devices strategic planning for
Marketing Authorization application.
Device trial - in-depth understanding.
Labelling requirments
Medical Device Post Approval Varitations |
PMA Supplements | PMA amendments |
Variation Management Strategic Planning
Advance training on technical dossier
preparation.
c-GMP requirement for medical devices.
Detailed training on ISO 13485 and CE
certification process.
Training on Medical device technical dossier
preparation.
Combination device approval process
RYD-034
483 OBSERVATIONS AND

WARNING LETTERS
3 days microlearning certification
This online training is to provide participants with an understanding of

483 Observations and Warning Letters in Pharmaceutical,
Biopharmaceutical and Medical Devices Industry. The course provides view Course
understanding on the parameters, approaches, and concerns of FDA
Content
inspections, and the tool to manage those inspections in the field of
pharmaceuticals.
This e-learning course provide comprehensive idea about the
following:
FDA as regulatory body and process including EIR, 483s, Warning
Letters, recalls, and other potential actions
The FDA inspection process and approach
Corrective Actions and Preventive Action (CAPA)
Flow of handling of warning letter from company side (who received
warning letter)
Follow up inspections
How to respond to inspection and audit results
RYD-033
DATA INTEGRITY IN PHARMA,

BIOPHARMA, MEDICAL
DEVICES
Data integrity online training course is provide basic fundamental know-
how about data integrity issues of pharma, biopharma and medical view Course
devices companies. This online course will help to understand the
concept of data integrity, interpreting expectations of regulatory Content
agencies. Moreover, the course helps to understand major data integrity
issues practically to avoid future mistakes.
RYD-036
CLINICAL RESEARCH
The objective of this course is to impart knowledge and

understanding with an opportunity to acquire and develop the
expertise necessary for effective clinical research. The program is
designed to meet the high demand for trained personnel for human
clinical trials. The program enable you to master practical aspects of view Course
clinical trial conduct and management including clinical trial phases
and design, planning, implementation, data analysis, regulatory and Content
procedural guidelines and ethical considerations.
RYD-042
PHARMACEUTICAL IPR
MANAGEMENT
1 month advance certification course
Intellectual Property Right Management courses are conceptualized
with vision to create effective IPR Manager for Pharmaceutical and
biopharmaceutical Industry. This course gives practical knowledge of view Course
the functionalities of IPR Manager with practical exposure.
Content
RYD-045
GMP AND GMP AUDIT

1 month advance certification course
GMP and GMP audit course provides comprehensive training for
Production, QA, QC and Regulatory professionals to handle and
management WHO-GMP requirement effectively. This course gives
practical knowledge on Plant inspection, EIR, Warning Letter, data
integrity and GMP violation management for pharma, biopharma and view Course
food industry.
Content
RYD-098
REGULATORY CMC WRITING

1 Month Certification Course
The online CMC writing training provides practical training on Chemistry, Manufacturing and
Controls (CMC) requirements for drug applications. In fact, the course provides review
processes for preformulation, non-clinical to clinical trial regulatory requirements for
registration and post approval drug applications. Moreover, the course provides hands-on
real life training on how to prepare drug submission dossiers. Hence, This online certificate
course in CMC writing is ideal for CMC specialists, regulatory affairs professionals who are
handling regulatory filing. Most importantly, this CMC writing course gives hands-on training
through simulation on CMC preparation and strategic planning process, which helps to
improve the dossier compilation process.
RYD-024
DRUG DOSSIER PREPARATION

The online Drug Dossier Preparation and filing provides practical training on drug
registration dossier preparation and submission process. In fact, this course provides real
life training on how to prepare drug submission dossier effectively. Hence, This online
certificate course in drug dossier preparation and registration is ideal for regulatory affairs,
Quality personnel, Business Development and International Marketing professionals working
in the pharmaceutical industry. Moreover, this course gives hands-on training through
simulation on dossier preparation, which helps to improve the dossier compilation process.
RYD-030
ANDA FILING AND STRATEGIC

MANAGEMENT
1 Week Certification Course
This online training on ANDA fling Strategic management provides training on the approval
pathway, submission and strategic planning process.
Regulatory Norms are ever-changing. Hence, there have been significant changes in FDA
expectations of Abbreviated New Drug Applications (ANDAs) since the passage of the Generic
Drug User Fee Act (GDUFA) in 2012. So, in this Abbreviated New Drug Application filing and
strategic management training course participants will learn about FDA requirements for for the
content, submission, and review of ANDAs. Therefore, objective of this course is to provide
hands on experience on ANDA filing process.
Most importantly, this course will provide comprehensive training on ANDA submission dossier
preparation, filing and related important topics. For example, ANDA format and technical
submission requirements, FDA expectations, fees, timelines under GDUFA. Above all, the
course will cover comprehensive strategic planning for the regulatory professional including
patent certification, patent and exclusivity periods, Para IV certification, 180 days exclusivity,
suitability petitions and the 505 (b)(2) NDA pathway. To sum up, this course focus on the ANDA
filing and strategic management steps which is must learn course for regulatory affairs,
business development, strategic management professionals.
Core Area of Learning in ANDA filing course
Drug Master Files and Site Master file

First of all, the course covers fundamental of drug
preparation and filings are covered in the
disovery development process.
course.
Followed by advanced understanding on generic drug
Next, under ANDA strategic management
approval process.
section, 505(b)(2), suitability petition
Thirdly, the course covers Abbreviated New Drug
application rationality and submission
Application (ANDA) submission process in detail.
process explained in detail. In fact, course
Most importantly, course provides in-depth
offers in-depth understanding on course
understanding on the Chemistry, manufacturing and
505 (b)(2) NDA. When does a “generic-
controls and ANDA Filing and submission dossier
like” drug become a 505 (b)(2) NDA.
preparation.
Also this course provides all inclusive
The course comprehensively covers ANDA strategic
understanding on Bioavailability and
management aspects like therapeutic ratings, patent
Bioequivalence study (BA BE study) which
certification, First to File, Para IV Filing, Para IV
is key for ANDA approval.
notices, 180 days exclusivity.
Above all, a brainstorming session
Concept and applicability of the GDUFA - Fees and
includes in FDA meeting and handling
FDA review timelines under GDUFA and Submission
FDA expectation.
expectations and content under GDUFA.
RYD-022
INLICENSING AND OUTLICENSING

This licensing online training course provides advanced practical real life training on
inlicensing and outlicensing deal. In fact the course covers entire strategic aspects of the in
and out licensing deal. Hence, pharmaceutical inlicensing and outlicensing course guides
each participant through licensing deal. Hence, it ensures in-depth understanding on
profiling to due diligence process. Moreover, the course will focus on portfolio analysis and
strategies for successful product pipeline management. Above all, the course provides
hands on training on biopharmaceutical brand valuation tools and techniques.
RYD-022
PHARMA FORECASTING
This Pharma forecasting training will provide practical understanding about the
pharmaceutical forecasting models, tools and techniques. Pharmaceutical forecasting
training covers pharmaceutical and biopharmaceutical market sizing and forecasting
models. Hence, this course will demonstrate sales forecasting skills what pharmaceutical
and biopharmaceutical managers to be successful. In fact, this pharmaceutical forecasting
course provides real life case based simulations for better understanding the complex
issues of market and new product forecasting. As a result, it is easy for participants to
understand the concepts. Moreover, cutting edge simulations help participants apply the
knowledge in interactive real life simulation.
This pharma selling skill training is ideal for the pharma sales representatives to enhance
pharma selling skills. Pharma medical representative training course gives practical
knowledge and real life job simulation. Course objective is to focus on pharma selling skill
training for pharma sales representatives. This course covers daily job role and
responsibilities of medical representative. Orientation to job related practical aspects of the
pharma sales representative (Medical Representative) is covered in this course
Medical Representative Training
Biopharma Medical
RYD-054 Representatives Selling
RYD-079 Skill Development
RYD-055 RYD-054
2nd line Manager /
1st line Manager /
RBM Training
ABM Training
Pharmaceutical Selling Skills

Selling Skills for Regional Training for Area Business
Business Manager (2nd Manager (1st Line Manager)
Line Manager)
Medical representative works in
This selling skill training course focus on individual role. They are responsible for
how to function as Regional Sales the performance of the territory. Medical
Manager in a pharmaceutical sales. representative, in turn, reports to Area
Regional Sales Manager are the second Sales Manger. Hence, when medical
line manager in pharmaceutical industry. representative promoted, they moves to
Hence, there is lot of chnage in job next level as Area Sales Manager. Area
function if you will be promoted to Sales Manager manages team of 4-5
Regional Manager from first line representatives. Therefore, we can say,
manager, that is area manager. This it is the first promotion of the medical
interactive skill training makes is simple representatives. As there is a shift of
to understand Regional Manager's job individual role function to managerial role
function effectively. function, it is important for
pharmaceutical company to groom the
new managers effectively. So that they
can function as company expects.
This is competency development online certification course for medical
sales representatives. These are stand alone skill enhancer training for
pharma sales professionals. These course gives practical knowledge
and real life job simulation for reffective understanding of the concepts.
All these courses are 3 days microlearning certification program, suits
working professionals.
Other Skill Training for Pharma, Biopharma

and Medical Devices Sales Professionals
RYD-057
RYD-055
Communication Negotiation
Skill Training Skill Training
Retail Chemist RYD-054 Sales Territory

Prescription Audit Management
Fundamental Training on Sales Analysis

Techniques for Pharmaceutical Sales
Professionals
A sales analysis is critical for success of the sales person as
report shows the trends of brands performance over time. In
its most basic form, a sales analysis report shows whether
sales are increasing or declining. At any time during the fiscal
year, sales managers may analyze the trends in the report to
determine the best course of action. In this online certification
course, one will be trained to different terminologies, tools for
pharmaceutical sales analysis. Course also provide effective
simulation for self assessment with real life sales data.
RYD-037
BIOPHARMACEUTICAL BUSINESS DEVELOPMENT
AND BRAND VALUATION
1 Week Competency Development Certification Course
Biopharmaceutical Business and Brand Valuation course is designed to train the practical working
knowledge and skill-set of Business Development and Licensing professionals. This course provides
comprehensive skill training for business development managers working in biopharmaceutical
industry. Biopharma Brand Valuation course covers brand valuation tools and techniques. Moreover
course provides detail understanding on business development deal financial management.
In these online self-paced modules, participants understands about valuation management of the
biopharma deals. In other words, you will understand how effectively manage the financials of the
deal. Moreover, this course focuses on how to devise the royalty in biopharma deal. Therefore, it
helps advance professionals to acquire cutting edged business skills.
RYD-039
PHARMACEUTICAL MARKETING PLAN
DEVELOPMENT
The online pharmaceutical marketing plan development training course provides training for brand
managers on how to prepare marketing plan. In pharma marketing, marketing planning always plays
a critical role. This course focus on how to prepare marketing plan for pharmaceuticals effectively.
Most importantly, course provides marketing plan samples in open format. Hence, this helps to
develop own database of the pharmaceutical marketing plan samples. Moreover, it will help to
develop the marketing plan development competency.
RYD-021
BASICS OF BIOPHARMA
The objective of this course is to impart basic fundamental know-how and practical understanding
about the different types of biopharmaceutical drugs and their regulatory approval process.
RYD-096
DRUG DEVELOPMENT
This online drug development training course focus on how the experimental drugs are designed and
developed. The course provides orientation to practical understanding in the entire drug development
process. Learn how to manage each steps of the drug development stages effectively. Further,
course provide extensive training on clinical trials which is key for the approval of the drug. Fourthly,
training includes regulatory pathways for approval. What exactly the requirement from regulatory
agency for approving the drug. Lastly, this online training helps you to understand the practical
timeline of the drug development process.
RYD-087
MEDICAL DEVICE REGULATION IN INDIA
This Course imparts knowledge and practical skills about the Regulation, Registration and approval
process in India. This advanced certification course in Medical Devices also covers medical devices
strategic management and planning process. Hence, this course will demonstrate medical devices
business skills and concepts to handle the medical devices business for India.
RYD-087
MEDICAL DEVICE REGULATION IN INDIA
This Course imparts knowledge and practical skills about the Regulation, Registration and approval
process in India. This advanced certification course in Medical Devices also covers medical devices
strategic management and planning process. Hence, this course will demonstrate medical devices
business skills and concepts to handle the medical devices business for India.
RYD-096
505(B)(2) APPLICATION SUBMISSION AND GUIDANCE
The 1 Week short Certification course is designed to provided comprehensive understanding of
the 505(b)(2) pathway. Focus is on learning requirements of real world issues associated with
creating and submitting 505(b)(2) applications. Course will focus on preparing a checklist to
construct a 505(b)(2) from scratch.
RYD-063
FUNDAMENTAL TRAINING IN NEW DRUG APPROVAL
3 Days Microlearning course
This New Drug Approval short orientation training provides fundamental understanding of regulation
and approval of the novel innovator pharmaceuticals. The course briefs how the new drugs are
discovered and developed and commercialized.
In this online self-paced modules, participant will be understanding about the new drug development
to commercialization process in detail. The course provide valuable insight on stages of drug
discovery and development, investigational new drug application, new drug application, handling of
different phases of clinical trials.
RYD-064
505(B)(2) APPLICATION SUBMISSION AND GUIDANCE
This short orientation training provides fundamental understanding of stability testing requirements
for establishing shelf life under cGMP criteria. The course provide valuable insight stability guideline
for finished pharmaceutical products, as well as active pharmaceutical ingredients.
RYD-023
PHARMA BRAND LOGO & IDENTITY DESIGNING AND
PLANNING
This practical online course trains the pharma product management professionals in pharma brand
logo and identity designing and planning. Participant will be understanding about the brand name
and logo development process in detail, with detailed understanding on how to prepare brand logo
for pharmaceuticals, biopharmaceutical molecules.
RYD-018
PHARMACEUTICAL VISUAL AID DEVELOPMENT.
In this online self-paced modules, participant will be understanding about the brand plan process in
detail, with detailed understanding on how to prepare visual aid for pharmaceutical brands.
BIOPHARMA PRODUCT CLASS TRAINING

Course Code Title Duration
Fundamental Training on Monoclonal Antibody

RYD-026 3 Days Microlearning
(MAB)
Fundamental
Training on Interferon
Fundamental Training on Erythropoieis

Stimulating Agent
RYD-018
TRADEMARK REGISTRATION IN INDIA
3 Days microlearning course
RYD-035
CE CERTIFICATION IN MEDICAL DEVICES
RYD-049
DRUG REGISTRATION AND REGULATION IN IDNA
RYD-051
ANDA & PARA IV FILING
RYD-058
DRUG REGULATORY AFFAIRS
RYD-088
MEDICAL DEVICES MEDICAL
REPRESENTATIVE TRAINING
1 week fundamental training
RYD-086
INCOTERMS
RYD-085
LETTER OF CREDIT MANAGEMENT
Course FAQs
Learn about the
How shall I take the admission? admission process
You can join the course online in 2 steps:
Step 1: Create your free account at www.royed.in.

Step 2: Login and Go your respective course page and you
can book or purchase the course effectively. Course will be
instantly activated after successful completion of the
course fees payment.
What is the eligibility criteria for the Royed courses?

Eligibility criteria for the admission in the course is mentioned below:
PG Certification: Graduation in any discipline. 3rd and Final year graduation
students can undergo the course.
Advance Certification, Microlearning courses, Competency Development
Training can be attended / pursued by anyone who requires the relevant
domain knowledge.
What is the training modes?

We have Online self Courses and customized corporate training which can be
online and onsite also.
How are Royed courses different from other providers?

At Royed, we are committed to providing the highest quality of on the job
learning. All our topics are designed with real life practical simulation.
Additionally, our training platform combines the convenience of online
training with the interactivity - Quizzes, case studies, break-out sessions,
polling, assessments.
Course participants receive the course analytics - performance by chapters and
also mentor evaluation reports for each section.
What are the different types of online courses available?
We have 4 types of online courses.
PG Certification - 1 Year Course.

Advance Certification - 1 Month Course.
Competency Development Program - 1 Week Course.
Microlearning Certification Course - 3 Days
Course FAQs
What kind of equipment do I need for training?
You only require Computer / any smart device with internet access. All our
courses are mobile device compatible. You can access the courses from
mobile too. Headphones will be ideal for listening to lectures effectively.
*There is no installation or downloading of the apps required.
Can I attend the training on mobile devices?

Yes, you can attend the lectures and entire course from any smart phone,
tab, IPAD, netbook etc.
Do I need to install any application?

You are not required to install any application / program in your system.
www.royed.in is a cloud based learning system. Therefore, you only need to
open www.royed.in in the browser and login with your credential to start
accessing the course.
What if I lose my login info? I lost my password?

You can reset your password. On the top sign in button you click, and then
you can reset the password by following on screen instruction.
Alternatively, You can mail us to info@royed.in or take help of Live Chat
Support. We will send you the user id and password to access in your email
id.
How to register for final examination?
You can login to your course page. Last section of the course will be having
the final examination. You can register and attend the final examination at
your convenient time and day.
When I can take the final examination?

You can take the final examination at your convenient date and timing,
within the course access period.
Course FAQs
Can I write my final examination anytime after expiry of

the course?
In case you have enrolled the course but due to some unavoidable reason,
could not be able to write the final examination within the course access
period, you can write final examination after scheduled period paying
additional Final Examination fees of 20 USD.
Note: There will be no fees for final examination if you write within stipulated
course time frame.
Do I need to pay for the final examination separately?

No. There are no additional fees other than course fees.
What if I failed to pass / could not attend the examination?

You need to reappear for RE-EXAMINATION. You will be able to appear for the
RE-EXAMINATION only after 2 days from the date of previous examination.
You need to take the RE-EXAMINATION date and appear as per the approved
date.
Are there any exam fees for re-examination?

No. There are no additional fees.
What is the pattern of final examination?
Generally final examinations will be online.
Time duration - Max. 2 hours (varies). Duration can be varying from 1/2 hour to
2 hour based on the course types, and the number of questions also vary
accordingly.
Types of questions: Multiple choice Objective type, short explanatory type.
Can I attend the final examination from mobile?

Yes. You can. But it is recommended to attend from the desktop or laptop or
tablet because of the relatively bigger screen size.
Can I extend the course duration?

Yes. You can. You need to apply for the course additional duration at least 7
days before the course expiry date. You can reach to info@royed.in or submit
your request via live chat.
Course FAQs
When will I be getting my certification after successfully

passing the final examination?
Final examination results and certificates will be sent to the registered email
id in 48 working hours time.
Do I get the certificate after completion of the course?

Yes. You will be awarded with a certificate after successful completion of the
course.
Royed issues learners one of two types of e-certificates. The types of e-
certificates are described below.
Course Participation Certificate: On completion of course schedule

duration, learners will be issued the course participation certificate.
Course Gradation Certificate: On successful completion of the course
online final examination, course certificate with % secured and grades will
be issued.
Can I complete the 1 Year PG Certification course within 6

months?
Yes, during your course tenure, you can write the final examination and
complete the course and get certified.
View our Alumni | Top Performers
Course Certificate
royed.in
Since 2012
ROYED TRAINING SERVICES

GSTIN: 19AMBPR7995J1Z4
98, Shyam Bazar Street.
Kolkata, West Bengal. Pin - 700005
Email: info@royed.in
Contact No. +91-984 557 1046
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ONLINE

GET SKILLED - GET CERTIFIED

Globally Since 2012

Interactive e-lectures (audio-visual), simulations, assignments and final

From desktop to mobile,

Course certificates will be provided at the end of the course.

Online final examination (Computer Based Test by secure mode), can be

In this catalogue to search any course

Royed Training is ISO 9001:2015 Certified Training Institute, dedicated to

Snapshot of Corporate Learning

Our Esteemed Clients info@royed.in www.royed.in

BIOPHARMA GLOBAL MANAGEMENT

Advanced Biopharmaceutical Strategic Management Course

Market Sizing, Forecasting Biopharma Branding Digital

PHARMA GLOBAL MANAGEMENT

Pharma global management course provides hands on training to enhance

Course comprehensively covers biopharmaceutical strategic

Drug Discovery, Development,

Pharma Branding, Marketing

International Business Development,

Plant certification, plant management,

Regional Business Development Strategies to manage

Middle East Africa ASEAN China Japan India

DRUG BIOLOGICS MEDICAL

Drugs Biologics Medical Devices

Course provides extensive training on country specific dossier

Most importantly, international drug regulatory affairs course covers

Feature of the course

Course provides extensive training on country specific dossier

Course only covers the drug and biologic regulatory affairs.

DRUG REGULATORY AFFAIRS

This PG Certification is designed to create effective Regulatory Affairs Manager for

Feature of the course

PHARMA SALES MANAGEMENT

The pharmaceutical sales management course is designed to

Feature of the course

Advance Selling Skill and Soft skill development

course gives practical knowledge and real life

Pharma Marketing Plan Development, Marketing Campaign Preparation, Brand

Feature of the course

Digital marketing training for

Feature of the course

Core Learning Area

Feature of the course

Feature of the course

PHARMA PRODUCTION AND

PG Certification in Pharmaceutical Production and operation Management is training on providing

Feature of the course

Feature of the course

Feature of the course

PHARMA INTERNATIONAL BUSINESS

Course covers International Business Development Training specific to MENA region.

Case Based Learning

PHARMA MARKET PHARMA MARKET

Feature of the course

Feature of the course

JAPAN DRUG REGULATORY

The course is an essential source of information and analysis on

Feature of the course

Orientation to practical understanding in the entire drug regulation,

BRAZIL DRUG REGULATORY

Feature of the course

Orientation to practical understanding in the entire drug regulation,

Feature of the course