CHULUNA

conferences
Extending
Pharmaceutical
Horizons
Hilton Leningradskaya Hotel
Moscow, Russia
17
th
– 19
th
September 2014
7
th
Practical Conference
12
th
from the Golden “Pharma” Series
Generics and Biosimilars in Russia and CIS
Ensuring the Stable Growth of Generics and Biosililars Market in the Framework of the Current
Regulatory Platform
Attending this Conference will Enable You to
• Discuss the dynamics of the generics and biosimilars market in the CIS
• Analyse the prospects of the pharmaceutical legislation in Russia
• Examine the legal aspects when launching generic drugs
• Apply the practice of pharmaceuticals registration in CIS and Europe
• Improve approaches to conducting clinical trials in the current
market conditions
• Identify the main requirements for the generic and biosimilar
drugs management within the Customs Union and the Common
Economic Space
Expert Speaker Panel
Timofey Nizhegorodtsev
Head of the Department
for Control over Social
Sphere and Trade
FAS of Russia
Vasily Boytsov
Director of Technical
Regulation and
Accreditation Department
EurAsEC Committee
Larisa Savinkina
Expert
National center for
expertise of drugs, medical
products and equipment
Ministry of Public
Health of the Republic
of Kazakhstan
Representative
Department for Medicine
Provision and Medical
Products Regulation
Ministry of Health
of Russia
Representative
State Duma Health
Committee
Marianna Sarkissova
Managing Director
PACE Business Partners
Rick Passenier
Director, Innovation and
Business Development
PACE Business Partners
Liliya Pentyashkina
Quality Assurance
Farmaplant GmbH
Igor Krylov*
General Director
Pharmstandard
Alexey Smirnov
Executive Director
PharmActa
Nikolay Bespalov
Chief Editor
PharmVestnik
Elena Artamonova
Chief Specialist of
the Leading Research
Department of New
Anticancer Drugs
Russian Oncology
Research Center n.a.
N.N.Blokhin RAMS
Olga Kravtsova
Registration Director
BIOCAD
Leonid Arkhipenko
General Director
Association of Honoured
Doctors of Russia
Ilya Nilva
PharmDR., Director
of Development
and Marketing
Veropharm
Alexandra Kitashova
Regulatory Afairs Director
GlaxoSmithKline
Pharmaceuticals
Edelgard Rehak
Medical Director
Zentiva
Head of Regulatory Afairs
Sanofi
Juan Vicente Esplugues
Mota, MD, PhD
Full Professor
of Pharmacology
Department of
Pharmacology
Faculty of Medicine
University of Valencia
Andrey Meshkovsky
Expert
World Health Organisation
Sanjay Singh
Chief Executive Ofcer
Gennova
Biopharmaceuticals Ltd.
Anastasia Nadezhdina
Legal Director
Valeant
Vadim Novikov
Senior Researcher
RANEPA
Member of the Russian
Government Expert
Committee
* Speaker to Be Confirmed
w
Including Interactive Workshop
on the 17
st
September 2014
The Practice of Organising Bioequivalence Studies
of Generic Drugs
Led by:
Alexander Khokhlov
Doctor of Medical Science, Professor
Vice President
Central Ethical Committee, Russian Ministry of Health
Chief Clinical Pharmacologist
Department of Health and Pharmacia of Yaroslavl Region
Andrzej Dzierbicky
Clinical Research Director
Polpharma
Miroslav Ryska
Leading European Expert in Bioequivalence Studies
Learn from Key Practical Case Studies
• BIOCAD defining the methods of forming registration dossier
for generics and biosimilars
• Veropharm implementing development strategies for generics
portfolio in Russia and CIS
• Valeant analysing the legal regulation for generic companies
• Sanofi sharing the practice of generic registration
• Pharmstandard discussing the prospects of the market development
Gold Sponsor Silver Sponsor
Media Partners
W Interactive Workshop
17
th
September 2014
12.30 Registration and Cofee
13.00 Opening Address from the Workshop Leaders
Interactive practical workshop will allow participants to discuss
the most important steps in the preparation of generics
manufacturers to conduct bioequivalence studies in the current
regulatory environment.
Measuring the Main Challenges of Running
Bioequivalence Studies
• Planning bioequivalence studies
• Analysing errors in the clinical section
• Managing the reports on bioequivalence studies
Led By:
Alexander Khokhlov
Doctor of Medical Science, Professor
Vice President
Central Ethical Committee, Russian Ministry of Health
Chief Clinical Pharmacologist
Department of Health and Pharmacia of Yaroslavl Region
Attendees will be able to enjoy tea and networking
opportunities through the workshop at 14.45
Topics Covered Include:
• Current Russian guidelines in BE studies: Comparison
of guideline 2008 and new guideline 2013 – impact
of diferences in PK parameters between these
two guidelines
• Comparison of new guideline with European guideline
• Current situation in clinical operations in BE studies in Russia:
Practical examples and diferent point of views
• Discussing issues with designing BE studies in Russia
(i.e. challenges with proper estimation of number of subjects
to be enrolled in BE study)
• Discussion about efcacy parameters in BE studies – do we
really need them?
Led By:
Andrzej Dzierbicky
Clinical Research Director
Polpharma
Topics Covered Include:
• Defning the stages of bioequivalence studies
• Measuring the main challenges of running
bioequivalence studies
• Discussing the potential use of the biowaiver procedure
Led By:
Miroslav Ryska
Leading European Expert in Bioequivalence Studies
16.30 Closing Remarks from the Workshop Leaders
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Who Should Attend
• CEO, Deputy CEO
• Regional Vice President, Country Head/Manager,
Head of Representative Ofce
• Business Development Director
• Head of Biopharmaceuticals Business Unit
• Medical Director
• Head of Departments, Licensing Managers, Registration
Managers, Head of Clinical Trials, Legal
from international and domestic pharmaceutical
companies involved in production and distribution
of generics and biosimilars, and originals.
As well as representatives of investment banks and market
research agencies, legal advisers, patent protection consultants
and other solution providers.
The Practice of Organising Bioequivalence Studies of Generic Drugs
P
P
Day One
18
th
September 2014
08.30 Registration and Cofee
09.00 Opening Address from the Chair
TRENDS IN THE GENERIC AND BIOSIMILAR MARKETS DEVELOPMENT
09.10 Russian Pharmaceutical Market: Catch Up and Surpass the Crisis
• Volume and dynamics of the market, the main problems of growth
• Key legislative innovations in 2013-2014 and their impact on the market
• Market forecast
• Discussing assortment policy of pharmaceutical companies in a crisis action
• Analysing the situation in the distribution system (ratings of wholesalers and
pharmacy chains)
Nikolay Bespalov
Chief Editor
PharmVestnik
09.50 Studying the CIS Generics Market Dynamics
• Analytical review on the key parameters of the CIS generics market
and development forecast for 2012–2013
• Latest global trends of the generics market development and their impact
on the local markets
• Specifc features of the CIS economies in the generics market development
Igor Krylov*
General Director
Pharmstandard
Speaker to Be Confirmed
10.30
11.00 Healthcare Business Acceleration
• Integral Innovation Management
• Product - Market Combinations
• Advanced Technology Transfer
• Strategic Partnerships
Marianna Sarkissova
Managing Director
PACE Business Partners
Rick Passenier
Director, Innovation and Business Development
PACE Business Partners
11.40 Case Study
Discussing the Generics Portfolio Lifecycle
• Improving the regulatory basis for the producers of generics
• Analysing the market structure of originals and generics
• Defning the nuances for clinical trials organisation
Alexandra Kitashova
Regulatory Afairs Director
GlaxoSmithKline Pharmaceuticals
12.20 Analysing the Recent Legislative Initiatives in Russia
• Introducing amendments and developing the Federal
La “On Drugs Circulation”
• Evaluating the recommendations of regulators to drug manufacturers
• Harmonising the drug registration system with European
Union requirements
Representative
Department for Medicine Provision and Medical Products Regulation
Ministry of Health of Russia
13.00 Lunch
14.00 Overview on the Pharmaceutical Market of Kazakhstan: Current
Trends and Development Potential of Generics and Biosimilars
• Studying the recent regulative updates in the sphere and discussing
the perspectives on the regulatory basis improvement
• Assessing the results and impact of changes on annual market dynamics
• Steps for registering generics and biosimilars in Republic of Kazakhstan
Larisa Savinkina
Expert
National center for expertise of drugs, medical products and equipment
Ministry of Public Health of the Republic of Kazakhstan
14.40 Analysing Quality and Efciency of Pharmaceuticals Nowadays:
Professional Community’s Point of View
Leonid Arkhipenko
General Director
Association of Honoured Doctors of Russia
PANEL DISCUSSION
15.00 Discussing the Relations of Doctors and Professional Associations
to the Use of Generics in Practice
The discussion will be joined by the representatives of the drug manufacturers,
medical institutions, as well as regulatory authorities
Leonid Arkhipenko
General Director
Association of Honoured Doctors of Russia
Elena Artamonova
Chief Specialist of the Leading Research Department of New Anticancer Drugs
Russian Oncology Research Center n.a. N.N.Blokhin RAMS
15.20
15.40 Case Study
Complex Regulatory Pathway for Biosimilars: A Case Study Based on
Elaxim (TNK-tPA, Third Generation Thrombolytic)
Sanjay Singh
Chief Executive Ofcer
Gennova Biopharmaceuticals Ltd.
LEGAL ASPECTS WHEN LAUNCHING GENERICS AND BIOSIMILARS LAUNCH
16.20 Case Study
Evaluating Legal Rights of Generic Drug Producers
• Discussing due diligence for generics manufacturers
• Implementing the full patent protection of originals in a situation
of domestic legislation
• Practical examples from the life business cases
Anastasia Nadezhdina
Legal Director
Valeant
PANEL DISCUSSION
17.00 Successful Strategies for the Protection of Original Drugs
in Aggressive Environments: Discussing the Ways to Find the Right
Market Balance and Developing Competition in the Field of
Intellectual Property on the Market
The discussion will be joined by the representatives of generic and original
pharmaceutical companies as well as the experts in the sphere of regulation and
regulatory authorities
Timofey Nizhegorodtsev
Head of the Department for Control over Social Sphere and Trade
FAS of Russia
Vadim Novikov
Senior Researcher
RANEPA
Member of the Russian Government
Expert Committee
Anastasia Nadezhdina
Legal Director
Valeant
17.40 Closing Remarks from the Chair
18.00 End of Day One
Business Development Opportunities
Does your company have services, solutions or technologies that
the conference delegates would benefit from knowing about?
If so, you can find out more about the exhibiting, networking and branding
opportunities available by contacting:
Athul George, Sponsorship Director, marcus evans London
Tel: +44 0 20 3002 3172, E-Mail: athulg@marcusevansuk.com
Booking Line:
Jana Borisova
Tel.: + 44 20 3002 3321
Fax: + 44 20 3002 3016
Email: JanaB@marcusevansuk.com
Business Development Opportunities
Does your company have services, solutions or technologies that
the conference delegates would benefit from knowing about?
If so, you can find out more about the exhibiting, networking
and branding opportunities available by contacting:
Jana Borisova, Marketing Manager, marcus evans London
Tel: +44 20 3002 3321, Fax: +44 20 3002 3016
E-Mail: JanaB@marcusevansuk.com
P
P
Day Two
19
th
September 2014
08.30 Registration and Cofee
09.00 Opening Address from the Chair
STRATEGIES OF THE BUSINESS DEVELOPMENT IN CIS
09.10 Case Study
Implementing Development Strategies for Generics
Portfolio in Russia and CIS
• The role and prospects of development of domestic generics in the strategy
of import substitution
• Analysing changes in the market structure of original and generic drugs
• Proper allocation of resources in the development of a generic portfolio
• Ensuring the ROI for new generic projects
Ilya Nilva
PharmDR., Director of Development and Marketing
Veropharm

IMPLEMENTING GMP IN RUSSIA AND CIS
PANEL DISCUSSION
09.50 Ensuring Compliance with the GMP Standard in CIS
• Reviewing the current applications of the standard
• Approaches to implementing GMP taking into account the local
market specifics
• Ensuring compliance with the requirements in the existing manufacture
in practice
Moderator:
Liliya Pentyashkina
Quality Assurance
Farmaplant GmbH
Panellists:
Sanjay Singh
Chief Executive Ofcer
Gennova Biopharmaceuticals Ltd.
Anastasia Nadezhdina
Legal Director
Valeant
10.30
CUSTOMS UNION INFLUENCE ON DRUG TURNOVER
11.00 Prospects for the Development of the Eurasian Economic Union’s
Common Market of Medicines, Including Generics and Biosimilars
Based on Common Principles and Rules of Regulation
Vasily Boytsov
Director of Technical Regulation and Accreditation Department
EurAsEC Committee
PANEL DISCUSSION
11.40 Evaluating Processes of Drugs Access on the Markets of the Member
States of the Customs Union and the Common Economic Space
The discussion will be joined by the representatives of generic and original
pharmaceutical companies as well as the experts in the sphere of regulation and
regulatory authorities
Vasily Boytsov
Director of Technical Regulation and Accreditation Department
EurAsEC Committee
EFFECTIVE PRACTICE OF GENERICS AND BIOSIMILARS REGISTRATION
12.20 Case Study
Overview of the Requirements for the Generics Registration Process
• Features of registration of generics in the CIS
• Discussing the legal framework in the feld of generic drugs
• Analysing the main reasons for registration refusal
• Reviewing documents necessary for registration of medicines nowadays
and after the new legislation is applied
Edelgard Rehak
Medical Director
Zentiva
Head of Regulatory Afairs
Sanofi
13.00 Lunch
14.00 Case Study
Methods of Forming Registration Dossier for Your Generics
and Biosimilars
• The procedure for preparing the registration dossier in Russia
• Discussing the features of the dossier preparation in diferent CIS countries
• Preparing an action plan for the registration and collection
of necessary documentation for the further research and studies
Olga Kravtsova
Registration Director
BIOCAD
14.40 The World Health Organisation and the Market of Generics
and Biosimilars
• Practical WHO recommendations for manufacturers
• Applying prequalifcation program for generics
• Recommendations of WHO in defning equivalence
Andrey Meshkovsky
Expert
World Health Organisation
15.20
DEVELOPING NEW HORIZONS
15.40 Practice of Generics and Biosimilars Registration
in the European Union
• Recent changes in regulation of EMA and their impact on the CIS market
• Preparing relevant documentation for the domestic products launching
on the European market
• The practice of conducting clinical trials in Europe
Alexey Smirnov
Executive Director
PharmActa
16.20 Generics vs Biosimilars: Diferences and Challenges,
a Clinical Overview
Juan Vicente Esplugues Mota, MD, PhD
Full Professor of Pharmacology
Department of Pharmacology
Faculty of Medicine
University of Valencia
17.00 Closing Remarks from the Chair
17.10 End of the Conference
Gold Sponsor
PACE Business Partners ofers business acceleration and innovation
services. Together with our clients, we create and accelerate business value
by increasing the impact and return on investment on innovation activities
and developing value based solutions that connect businesses, technologies,
products and markets. PACE Business Partners accelerates integral innovation
management, project portfolio management, new product development,
strategic partnerships and technology transfers.
Silver Sponsor
Farmaplant is a German pharmaceutical company with the main ofce
located in Hamburg. During the last three years Farmaplant cooperates
with the pharmaceutical plants in Russian and the Ukraine operating as
a supplier of substances and as a protector of good quality of pharm raw
materials. The key customers of Farmaplant are pharmaceutical enterprises
manufacturing finished dosage forms as well as companies releasing drugs
under the unique trading marks. Farmaplant provides a complete package
of documents for pharmaceutical substances and finished dosage forms,
assists in authorization of pharmaceutical substances, provides drugs in bulk
form, controls the product quality and renders logistics services.
Booking Line:
Jana Borisova
Tel.: + 44 20 3002 3321
Fax: + 44 20 3002 3016
Email: JanaB@marcusevansuk.com