Masterclass

www.aurelius.in

Clinical Trials
"Enhancing quality in clinical trials after
implementation of new ICH E6 R2
addendum."
17th to 19th SEPTEMBER 2019 | Amsterdam, the Netherlands

www.aureliusglobalmasterclass.com +44 203 239 8083 masterclass.registrations@aurelius.in

 Course Objectives
Key Topics
Risk assessment This interactive advanced GCP course is
recommended for those who have experience
Risk management in the clinical trial process and wish to
Risk-based monitoring develop their skills.
Central monitoring The course involves active interaction between
Safety reporting the trainers and the participants
during the presentation. There is a lot of group
Computerised systems work facilitated by the trainers. Anonymized case
Validation of computerised systems studies from real lifewill be used for discussion
IMP handling according to GCP and problemsolving.
After the course, you will have a good
EU Annex 13 understanding of:
Sponsor & investigator oversight
QA and audit plan Interpretation of the updated GCP
Protocol deviation and CAPA requirements and how to implement them in
practice with regards of risk-based approach
Handling of data and risk assessment
(e)TMF Corrective Action and Preventive Action
Risk-based audit and quality plan

Key Takeaways Sponsor and investigator oversight

Handling of protocol deviation
Handling of source data
Discover important developments such Essential requirements of EMA Trial
as riskbased approaches to trial Master File Guidance from Dec. 2018
Safety reporting and Reference Safety
management & oversight. Information
Develop GCP problem solving skills by Requirements to computerised systems and
considering the most common electronic data
Handling of investigational medicinal
problems encountered in clinical trials.
products (IMPs)
Have a complete understanding of
different processes in a clinical trial
Explore the most important rules.
related to handling of clinical trial data.
Gain understanding of trial master file
requirements.

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www.aureliusglobalmasterclass.com +44 203 239 8083 masterclass.registrations@aurelius.in ONLINE
Your Prominent Trainer:

Jo Burmester
Clinical Research Training Consultant
Jo is a pharmacology graduate and began her career in clinical research in 1987.

She worked as a CRA and senior CRA for 5 years before moving into a full time clinical research training role in 1992.
She has designed and delivered clinical research and soft skills training for a wide variety of audiences and has managed
training departments in two global organizations.

Her career has included experience in the pharmaceutical industry (Glaxo, Lederle and Wellcome) and the CRO world
(ClinTrials Research and Quintiles) and she has worked internationally, covering both ICH and FDA requirements.

She was a founding Director of Pharma School for 14 years, and is now the CEO of JoBurmester.com. She holds a
Certificate in Training and Development from the Chartered Institute of Personnel and Development, was a Module
Leader on the MSc Program run at Liverpool John Moore’s University.

She regularly chairs and speaks at international clinical research conferences and is the author of a book on Continuing
Professional Development.

Training audience Special features

Clinical Quality Assurance Bring your own case studies
Clinical Auditing that needs to be clarified
Clinical Quality & Pharmacovigilance All delegates will receive
Medical Quality comprehensive course
Development Quality documentation
Medical Compliance Certificate of Attendance
R&D QA issued by the trainers
Clinical CAPA 3 Days of Intensive Learning
Clinical quality oversight 5H+ Practical Workshops &
Clinical Data Quality Discussions
GCP Compliance 6H+ Networking
Clinical Quality Project Management Hands-on examples
Clinical process management
Trial Master Files

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www.aureliusglobalmasterclass.com +44 203 239 8083 masterclass.registrations@aurelius.in ONLINE
 DAY 1
8:30 Registration & Welcome
14:00 Workshop & Discussion
Coffee
8:25 Welcoming Note and Opening • Cases and Discussion: Risk Assessment and
Remarks Risk Management
• Cases and Discussion: Risk-based
9:10 Introduction & speed Networking
monitoring and Central monitoring
9:20 Quality Risk Management • Review of a small biotech company‘s quality
Risk Assessment and Risk Management
management system
• Purpose of quality risk management
• How to create a risk management plan for a
• How to identify and assess risks
GCP-2019 clinical trial
• How to mitigate risks
• How to do risk-based monitoring for a GCP-
• How to review risks
2019 clinical trial
• How to communicate and document
risks 15:00 Afternoon Refreshments &
10:00 Morning Coffee & Networking
Networking 15:30 Safety reporting
10:30 Quality Risk Management
• GCP requirements and EU CT-3 guidance for
Risk Assessment and Risk Management
safety reporting
• Case studies from delegates
• Adverse Events assessment and reporting
11:30 Risk-based monitoring and Central timelines
monitoring
• Investigator and Sponsor responsibilities in
• Risk-based monitoring - since when
handling of adverse events
• Legal changes
• SUSAR reporting
• Expectations of competent authorities
• Reference Safety Information challenges
• Who is responsible for monitoring?
Case studies will be provided for discussion.
• Central monitoring - since when
• Expectations of competent authorities 17:00 Review of Day 1

12:30 Luncheon 17:15 Networking

13:30 Risk-based monitoring and Central
monitoring
• Program continued
• Case studies from delegates

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ONLINE
 DAY 2
9:00 Opening remarks from the training
leaders 14:00 Sponsor & investigator oversight
9:10 Computerised systems and validation • Inspection – what is it about?
• Know the guidelines and requirements • Sponsor & investigator obligations
• Understand the legal framework • Sponsor & investigator tools
• Understand the expectations of competent 15:00 Afternoon Refreshments &
authorities Networking
• Understand the validation requirements 15:30 Sponsor & investigator oversight
• Workshop
10:30 Morning Coffee &
Networking 16:00 QA and audit plan
11:00 Computerised systems and validation - • Organisation
continued • Obligations
• Workshop • Tools
11:30 IMP handling according to GCP and 17:00 Review of Day 2
Annex 13
• GCP requirements for the sponsor related 17:15 Networking
to IMP
• EU Annex 13
• Handling of IMP at sites
• Distribution to sites
• Transfer of IMP between sites
• Handling of IMP temperature deviations
and complaints
Case studies will be provided for discussion.

12:30 Luncheon
13:30 IMP handling according to GCP and
Annex 13 – continued
• Workshop

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ONLINE
 DAY 3
8:30 Protocol deviations and CAPA 15:50 Panel Discussion Session with our
• How to categorise protocol deviations esteemed trainers
• Protocol deviations as serious breaches • Case Studies brought up by participants
• How to handle protocol deviation by the • Panel Discussion
investigator • Q & A Session
• How to handle protocol deviation by the • Design your strategy
sponsor 16:30 Closing remarks from the training
• How to prevent protocol deviations leaders
Case studies will be provided for discussion.

10:30 Morning Coffee &

Networking
11:00 Handling of Data
• Storage
• Formats
• Pitfalls

11:00 Handling of Data

• Workshop and case studies

12:30 Luncheon

13:30 eTMF
• Guideline and regulation
•Transformation – paper and electronics
• Storage

14:40 Afternoon tea &

networking
15:00 eTMF
• Workshop & case studies

REGISTER
www.aureliusglobalmasterclass.com +44 203 239 8083 masterclass.registrations@aurelius.in
ONLINE
Registration Form
Clinical Trials | 17th to 19th September 2019 | Amsterdam, The Netherlands

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 In-House Trainings
Specific industries face specific problems. They require niche informa-
tion and solutions. In-House Training is precisely engineered to your
needs.

Taking place in the privacy of your company, including real-life case

studies and best practices, the course is led by an independent indus-
try expert.

We have the best subject matter experts (empanelled with us)

globally which further help us to draft agenda in line of needs &
which is delivered at the convenient time & venue to you.

Provide your employees a unique learning experience without having

to leave the office, interruption of work and duties & incurring travel
costs.

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ABOUT
AURELIUS
Aurelius Corporate Solutions is a first of its kind on
demand Insourcing Multiplier. We are a one stop
shop for all technical and functional Insourcing
Needs. Being an In-sourcing Multiplier, with almost
a decade of experience we facilitate in-sourcing fis-
sion across organization (technical and functional),
by enabling your people to do your business better.
We are a one of its kind Insourcing Multiplier – we
help solve business problems, this is done through
our clan of empanelled SMEs real time on anytime
any where basis.
Aurelius gets its farsighted and guiding path light
from its Founding Leaders, who bring with them
several decades of technology sales and marketing
experience, coming from an IVY League University,
the Management has travelled more than 60 coun-
tries for business before starting this Venture.
Insourcing Solutions
TRAINING Solutions
MASTERCLASSES
WE ENABLE YOUR
PEOPLE TO DELIVER
YOUR BUSINESS BETTER
So far we have successfully delivered more than 1000 plus unique tech-
no-functional in-sourcing projects, in and around 30 countries. We today
boost of 700 plus corporate customers most of which are Fortune 500 compa-
nies. We have enabled more than 70 K plus professionals worldwide in over 30
plus countries. Aurelius has a clan of 100,000 plus clan of global SME empan-
neled worldwide and there are about 100 plus media houses and publications
nationally and internationally which have written about Aurelius and spoken
for the work and contributions done so far.
Masterclasses is yet another feather in our hat. Through these advanced Mas-
terclasses we are able to provide solutions to some of the most complex and
advanced subjects within the industry. We believe we can source and channel
the most complex and updated knowledge in various industrial sectors and
provide them to the organizations who need it to reach their true potential.