Program
"Generic Medicines for Better Access and Sustainable Healthcare"

Main Conference

December 4, 2012 (Tue): Main Conference (Evening before Day 1)
Time Session Subject Moderator: Mr. T. Fujino, JGA
17:30～18:30 Special Session, Science Committee "Pharma Regulatory Matters of recent development in Indonesia and ASEAN harmonization. "
Chair: Dr. Nicholas Cappuccino
Speaker: Dra. Lucky S.Slamet, MSc., Head of NADFC, Republic of Indonesia
19:00～21:00   Registration and Welcome Reception
Welcome Speeches
Mr. Hiroyuki Sawai, Chairperson, Japan Generic Medicines Association (JGA) and
a representative of Platinum sponsors
December 5, 2012 (Wed): Main Conference (Day 1)
Time Session Subject Moderator: Mr. T. Fujino, JGA　
07:30   Registration and Networking Coffee
08:30   Welcome Address
Mr. Hiroyuki Sawai, Chairperson, Japan Generic Medicines Association (JGA)
08:40 Keynote Speech Opening Keynote Speech:
"Promotion of the Use of Generic Drugs in Japan"
Dr. Norihisa Hara, Director General, Health Policy Bureau, MHLW, Japan
09:00 Session 1 Activities of International Organizations and Global Pharmaceutical Business
Chair: Mr. Jim Keon, President, Canadian Generic Pharmaceutical Association (CGPA)
09:05 The Interface Between Public Health, Trade and TRIPS: Current Work at the WTO and How It Relates to the Generic Industry
Mr. Roger Kampf, Counsellor, Intellectual Property Division, WTO
09:40 Pharmaceutical Policy of WHO
Dr. Lembit Rägo, Coordinator, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Policy, WHO
10:15 Global Pharmaceutical Business and Generic Medicines Market
Mr. Alan Sheppard, Principal, Generics Thought Leadership, IMS Health
10:50 Question and Answer　
11:00 Networking Coffee Break　
11:25 Session 2 Future of Generic Medicines Industry - Recent Trends of Biosimilars
Chair: Mr. David R. Gaugh, R.Ph., Senior Vice President for Sciences and Regulatory, GPhA
11:30 Global Generic Medicines Business through Investment Banker's Crystal Ball
Mr. Vijay P. Karwal, CFA; Managing Director, Head of Industrials, Consumer & Healthcare, CIMB Investment Bank
11:55 Biosimilars, US and Beyond - When and How Much?
Dr. Viren Mehta, Mehta Partners
12:20 Biosimilars, a Global Opportunity? An EU perspective
Ms. Suzette Kox, Senior Director Scientific Affairs, European Generic medicines Association (EGA)
12:45 Question and Answer　
12:55 Networking Buffet Lunch
14:25 Session 3 Reviews and Market Trends I
Chair: Mr. Greg Perry, Director General, European Generic Medicines Association (EGA)
１4:30 Canada:
Mr. Barry Fishman, President & CEO, TEVA Canada Limited and Chair, CGPA
14:55 Europe: market trends during the current economic crisis
Mr. Victor Lino Mendonça, Head of Pharmaceutical Policy and Health Economics, EGA
15:20 U.S.:
Mr. Shawn Brown, Vice President of International
Government Affairs, Watson Pharmaceuticals
15:45 India:
Dr. Kailash D. Sharma, Ph D., MBA, President & Representative Director,
Zydus Pharma Japan Co., Ltd.
16:10 Japan: Trends of Generic Medicines Market in Japan
Mr. Kenichi Nagano, Director General, Japan Generic Medicines Association (JGA)
16:35 Question and Answer　
16:45 Close of Day One
19:30～22:30 Reception and Gala Dinner　
December 6, 2012 (Thurs): Main Conference (Day 2)
Time Session Subject Moderator: Mr. T. Fujino, JGA
07:30   Networking Coffee　
08:30   Opening Statement for Day 2　
Mr. Yoshiro Mukai, Vice Chairperson, Japan Generic Medicines Association (JGA)
08:40 Keynote Speech Day 2 Keynote Speech for Day 2:
Current Status of Generic Medicines and Activities of Japan Society of Generic Medicines
Dr. Masaki Muto, Chairman, Japan Society of Generic Medicines
Professor, International University of Health and Welfare Graduate School
09:00 Session 4 Recent Key Issues on Intellectual Property Rights　
Chair: Dr. Yehudah Livneh, Chairperson, Intellectual Property Committee, IGPA
09:05 International Patent System - Future of Intellectual Property Rights
Ms. Tomoko Miyamoto, Head, Patent Law Section, Patents and Innovation Division, WIPO
09:35 Europe：Enforcement of patent rights in The EU: finding the right balance between innovation and fair competition
Ms. Lidia Mallo, Senior Manager, Government Affairs, European Generic medicines Association (EGA)
09:55 USA: IP Reform and Access to Generic Medicines
Mr. Charles O'Sullivan, Director, Medical Affairs & Governmental Affairs, Hospira
10:15 Japan: Recent IPR Law Development and TPP
Dr. Yoshio Yagyu, Chair, Intellectual Property Committee, Japan Generic Medicines Association (JGA)
10:35 Question and Answer　
10:45   Networking Coffee Break
11:00 Session 5 CEO Panel: Challenges and Opportunities for Generic Medicines Development
Chair: Mr. Alan Sheppard, IMS Health
11:05 Europe:
Ms. Gudbjorg Edda Eggertsdottir, European Generic medicines Association (EGA), President and Actavis President Iceland & EVP Strategic Projects
11:25 USA:
Mr. Tony Mauro, President of Mylan North America
11:45 India :
Mr. Ray Tsunoda, President & Representative Director
Kyowa Pharmaceutical Industry Co., Ltd. (A Lupin Company)
12:05 Japan:
Mr. Junichi Nakamichi, Country Head, Japan, Sandoz K.K.
12:25 Japan:
Mr. Mitsuo Sawai, President, Sawai Pharmaceutical Co., Ltd.
12:45 Question and Answer　
13:00   Networking Buffet Lunch　
14:00 Session 6 Bioequivance Requirements in Different Regions
Chair: Ms. Suzette Kox, Senior Director Scientific Affairs, European Generic Medicines Association (EGA), Vice-Chair - Science Committee, IGPA
14:05 Bioequivalence Requirements in USA and EU and Their Background Concept
Dr. Nicholas Cappuccino, Chair - Science Committee, IGPA
14:25 Bioequivalence Requirements in Japan and Their Background Concept
Dr. Hiroyasu Ogata, Director, Japan Society of Generic Medicines,
Professor Emiritus, Meiji Pharmaceutical University, Visiting Scientist, National Institute of Health Sciences (NIHS)
14:45 Question and Answer　
14:55   Coffee Break　
15:10 Session 7 Reviews and Market Trends II
Chair: Mr. Jim Keon, President, Canadian Generic Pharmaceutical Association (CGPA)
15:15 Brazil:
Mr. Luciano Lobo, Technical Administrative Manager
Pro Genericos
15:30 Jordan:
Mr. Mazen Tantash, Chairman, Jordanian Association of Pharmaceutical Manufacturers (JAPM)
15:45 South Africa: The Development and Impact of Generic Medicine Usage in South Africa
Dr. Fathima Docrat, CEO
National Association of Pharmaceutical Manufacturers（NAPM）
16:00 Taiwan:
Ms.Tiffany Chen, Chairperson of Marketing Development Committee, Taiwan Generic Pharmaceutical Association (TGPA)
16:15 Question and Answer　
16:25   IGPA 2013 - Europe: Introduction of the 16th IGPA Annual Conference
European Generic Medicines Association (EGA) A short speech by Mr. Greg Perry
16:40   End of Conference - Closing Speech: 　　　　
Mr. Itsuro Yoshida, Vice Chairperson, Japan Generic Medicines Association (JGA)
17:00～18:30   Farewell Cocktails