Scientific Program

Day 1| Wednesday, 4 February
7:30 – 8:30 WELCOME COFFEE AND ATTENDEES REGISTRATION
Theme: Good Review Practices
8:30-9:40

Session 1: Opening Ceremony

Opening remarks from Conference Chairpersons
Ms. Estelle Michael
AstraZeneca, United Kingdom

WELCOME FROM GUEST OF HONOR
Dr. Ming-Neng Shiu

Ministry of Health and Welfare, Taiwan
Dr. Shiow-Ing Wu
Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan

Welcome from Partners
Dr. David Jefferys
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Switzerland;
Eisai Europe Ltd, United Kingdom
Haijun Dong, PhD, MBA 
DIA, Greater China

Keynote Speakers
Dr. Lembit Rägo (by video)
World Health Organization (WHO), Switzerland
A/Prof. John C.W. Lim
Ministry of Health, Singapore;
Centre of Regulatory Excellence (CoRE), Duke-NUS Graduate Medical School, Singapore

9:40 -10:30 Session 2: Maximising Good Regulatory Practice – What More is Needed and Why?
Opportunity to hear what eminent regulators think about current good regulatory practice and potential improvements for the future.
Question - What more is needed to make good regulatory practices a reality for the region? Does it necessarily need regulatory amendments or just changes in working practice?
SESSION CHAIRPERSON
Prof. Stuart Walker
Founder, Centre for Innovation in Regulatory Science (CIRS), United Kingdom

Panelists
Ms. Justina Molzon
CAPT (retired) US Public Health Service formerly Center for Drug Evaluation and Research US Food and Drug Administration Associate Director for International Programs, United States
Dr. Junko Sato
Division Director, Division of Regulatory Cooperation Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Barbara Sabourin
Director General, Therapeutic Products Directorate, Health Canada
Ms. Li Ling Liu
Director, Division of Medicinal Products, Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan

10:30-11:00 Coffee Break

11:00-12:30
Session 3: Principles of Good Review Practice
Update on current ‘good review practice’ activities inside and outside the Asian region.
Session Chairpersons:
Ms. Li Ling Liu
Director, Division of Medicinal Products, Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan
Florence Houn, MD MPH FACP
Co-chair, Food and Drug Administration Alumni Association (FDAAA) International Network, United States; Vice-President, Global Regulatory Intelligence Policy and Strategy, Celgene Corporation, United States

Speakers
Ms. Barbara Sabourin
Director General, Therapeutic Products Directorate, Health Canada
Ten Years of Good Review Practices at Health Canada
Florence Houn, MD MPH FACP
Co-chair, Food and Drug Administration Alumni Association (FDAAA) International Network, United States; Vice-President, Global Regulatory Intelligence Policy and Strategy, Celgene Corporation, United States
Update on Current ‘Good Review Practice’ Activities Inside and Outside the Asian Region
Dr. Tomas Salmonson
Chair, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), Europe
"Good Review Practice"Concept - An European View
Dr. Woo Young Oh
Division of Gastroenterology and metabolism products, Ministry of Food and Drug Safety (MFDS), South Korea
Good Review Systems in South Korea

12:30-13:30 Lunch
13:30 -15:00 Session 4: Co-operation, Convergence, Competencies & Capacity, and Communication in Managing the Review
Real live experience-sharing of the application of the 6 Cs from different perspectives. Key learnings from international & regional initiatives.
Session Chairpersons:
Ms Cordula Landgraf
Head of Networking, Swissmedic, Switzerland
Mr Arun Mishra
Director and Head, Regulatory Affairs, Abbott, India
Speakers:
A/Prof. John CW Lim
Deputy Director of Medical Services (Industry & Research Matters), Ministry of Health;
Executive Director, Centre of Regulatory Excellence (CoRE), Duke-NUS Graduate Medical School, Singapore
Examining 6 Cs of Good Regulatory Review Practices
Ms Cordula Landgraf
Head of Networking, Swissmedic, Switzerland
Evolving regulatory cooperation platform for the review of generics – IGDRP Initiative
Prof. Stuart Walker
Founder, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Update on Southeast Asia Benefit Risk Evaluation (SABRE) Program
15:00 -15:30 Coffee Break
15:30 - 17:00 Session 5: Hot Topic: Achieving Earlier Patient Access to Medicines
Exploration of different approaches which aim to “achieve early patient access to medicine” from within and outside the Asian region.
Questions - what are the new approaches to regulatory review process? As examples, what is the Japan’s SAKIGAKE Project? What are US FDA’s new and existing expedited approval pathways?
Session Chairperson:
Prof. John Skerritt
National Manager, Therapeutic Goods Administration Department of Health (TGA), Australia
Speakers:
Dr. Nobumasa Nakashima
International Planning Director (Pharmaceutical Affairs), Ministers Affairs, Ministry of Health and Labour and Welfare (MLHW), Japan
Strategy of Sakigake 
Dr. David Verbraska
Vice President, Worldwide Policy and Public Affairs, Pfizer, United States
Speeding Patient Access to Medicine: Expedited FDA Review and Approval Pathways
Dr. Hans Georg Eichler
Senior Medical Officer, European Medicines Agency (EMA), Europe
Achieving Earlier Patient Access to Medicines – Perspective from the European Medicines Agency (EMA)
End of Day 1

 


Day 2| Thursday, 5 February
7:30 – 8:30 WELCOME COFFEE AND ATTENDEES REGISTRATION
Theme: Good Submission Practices
8:30-8:45 Session 6: Opening Day 2

Conference Chairpersons
Ms. Li Ling Liu
Director, Division of Medicinal Products, Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan
Ms. Estelle Michael
Senior Policy Director, AstraZeneca, United Kingdom
Day 1 key highlights

Keynote Speaker
Mr. Akihiko Matsubara
Managing Director, Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Outline of APAC Activities

8:45 -10:00 Session 7: APAC’s Good Submission Practice (GSubP) Guideline for New Drug Application - New Industry Initiative by Asian Pharma Associations-
A moderated panel discussion with contributions from the floor to review and discuss APAC’s draft guidelines on good submission practice.
Question - What more can industry do to assist the process towards good submission practice? What are the current industry-led initiative(s) or tools developed in Asia?
Session Chairperson:
A/Prof. John CW Lim
Deputy Director of Medical Services (Industry & Research Matters), Ministry of Health;
Executive Director, Centre of Regulatory Excellence (CoRE), Duke-NUS Graduate Medical School, Singapore
Dr.Toshiyoshi Tominaga
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelists:
Mr Isao Sasaki
APAC Regulations and Approvals-Expert Working Group (RA-EWG) Deputy Director, JPMA
Director, Asian Regulatory Affairs, Regulatory Affairs Japan, Astellas, Japan
APAC Good Submission Practice (GSubP) Guideline for Applicants
Dr. Churn-Shiouh Gau
Executive-Director, Center for Drug Evaluation (CDE), Taiwan
Mr Kum Cheun Wong
Co-Chair Regulatory Affairs Committee, Singapore Association of Pharmaceutical Industries (SAPI);
Head Asia Pacific Policy & Liaison, Drug Regulatory Affairs, Novartis, Singapore
Ms Justina Molzon
CAPT (retired) US Public Health Service formerly Center for Drug Evaluation and Research US Food and Drug Administration Associate Director for International Programs, United States
Dr. Woo Yong Oh
Division of Gastroenterology and metabolism products, Ministry of Food and Drug Safety (MFDS), South Korea
10:00-10:30 Coffee Break
10:30-12:00 Session 8: Good Submission Practice for the ASEAN Region
In this second panel discussion the focus will focus on ASEAN and a discussion with regard to industry’s experience of good submission practice with ASEAN countries, while seeking feedback from Regulators.
Session Chairperson:
Dr. Ashley Preston
Head of International, Global Regulatory & Scientific Policy, Merck, Singapore
Panelists:
Dr. Looi Yee Hoo
Regulatory Consultant, Therapeutic Products Branch, Pre-Marketing, Health Products Regulation Group, Health Sciences Authority (HAS), Singapore
Dr. Tharnkamol Chanprapaph
Pharmacist, Senior Professional Level, Drug Bureau Food and Drug Administration Office (ThaiFDA), Ministry of Public Health, Thailand
Dato’ Eisah A. Rahman
Senior Director, Pharmaceutical Services Ministry of Health, Malaysia
Ms Jayanthi Boobalan
Asia Regulatory Country Strategist, Worldwide Safety & Regulatory, Pfizer, Malaysia
Ms. Pia Angelique De Mesa – Priagola
Food Drug Regulation Officer III, Licensing and Registration Division, Center for Drug Regulation and Research, Philippines
12:00-13:00 Lunch
13:00 -14:30 Session 9: Evolving and Establishing Regulatory Framework for Multi-Regional Clinical Trials (MRCTs)
Debate on global clinical development benefits and challenges and related regulatory framework this requires.
Questions - What are companies’ experiences with undertaking global MRCTs? What is sub-group analysis potential impact on output from global trials – role of biostatistics and new methodologies? Is there any trend towards ‘one CTA’ in North Asia, i.e. single dossier requirements for Korea, Taiwan, Japan and China with harmonization of ethnic sensitivity assessment?
Session Chairpersons:
Dr. Yasuko Asahina
Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms Estelle Michael
Senior Policy Director, AstraZeneca, United Kingdom
Speakers:
Dr. Yasuko Asahina
Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA’s Perspective on Good Submission Practice for Global Clinical Development
Prof. Oliver Yoa-Pu Hu
Vice-Chair of Special Interest Group (SIG), International Pharmaceutical Federation (FIP), Taiwan
Evolving and Establishing Regulatory Framework for Multi-Regional Clinical Trials
Ms. Hsueh-Yung (Mary) Tai
Deputy Director, Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan
Multi-Regional Clinical Trials Experience in Chinese Taipei
Ms. Hui (Angela) Yan
Senior Director for Science and Regulatory Affairs, R&D-based Pharmaceutical Association Committee (RDPAC), China
China IMCT/MRCT Draft Guideline and RDPAC Suggestions
Mr. Xiang (Tony) Guo
Senior Director, Head of Statistics, Biostatistics and Research Decision Sciences – Asia Pacific, Merck Research Laboratories, China
A Nested Group Sequential Framework for Regional Evaluation in Global Drug Development
14:30 -15:30 Coffee Break and Networking Session
15:30 – 17:00 Session 10: Hot Topic: Regulatory Convergence – Update on Regional Harmonization Initiatives with a Particular Focus on APEC
Focus on APEC and the related numerous projects that have been kicked off in and for the Asian region.
Question - What are APEC latest developments? What are the next steps stemming from the different initiatives/activities launched to drive sustainable change in Asia?
Session Chairperson:
Ms Justina Molzon
CAPT (retired) US Public Health Service formerly Center for Drug Evaluation and Research US Food and Drug Administration Associate Director for International Programs, United States
Speakers:
Ms Justina Molzon
CAPT (retired) US Public Health Service formerly Center for Drug Evaluation and Research US Food and Drug Administration Associate Director for International Programs, United States
Update on APEC Regulatory Harmonization Steering Committee
A/Prof. Silke Vogel
Deputy Director, Centre of Regulatory Excellence (CoRE), Duke-NUS Graduate Medical School, Singapore
Example of a Future Center of Regulatory Excellence (CoRE): The MRCT Pilot in Collaboration with Duke-NUS 
Mr Kiminori Nagao
APAC Regulations and Approvals-Expert Working Group (RA-EWG) Director, JPMA
Vice President, Asia Development (Region Head), Daiichi Sankyo, Japan
Industry Perspective on Regulatory Convergence Within the APEC Region 
17:00 – 18:15

Session 11: Closing Panel Discussion
Good Registration Practices  - Regulators and Industry Views  on Review and Submission Aspects

CONFERENCE CHAIRPERSONS
Dr. Shiow-Ing Wu
Deputy Director-General, Food and Drug Administration, Ministry of Health and Welfare, Taiwan
Ms Estelle Michael
Senior Policy Director, AstraZeneca, United Kingdom
Panelists:
Florence Houn, MD MPH FACP
Co-chair, Food and Drug Administration Alumni Association (FDAAA) International Network, United States; Vice-President, Global Regulatory Intelligence Policy and Strategy, Celgene Corporation, United States
Dr. Junko Sato
Division Director, Division of Regulatory Cooperation Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Li Ling Liu
Director, Division of Medicinal Products, Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan
Mr Kiminori Nagao
APAC Regulations and Approvals-Expert Working Group (RA-EWG) Director, JPMA
Vice President, Asia Development (Region Head), Daiichi Sankyo, Japan
Mr Chih-Ping Yang
General Manager, Chugai Pharma Taiwan;
Standing Director, International Research-Based Pharmaceutical Manufacturers Association (IRPMA), Taiwan
Dr. David Jefferys
Vice-Chair, Regulatory Policy and Technical Standards Committee, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Switzerland;
Senior Vice President, Global Regulatory, Government Relations, Public Affairs and European Product Safety, Eisai Europe Ltd, United Kingdom

18:15 – 18:30 Session 12: Closing Remarks by the Conference Chairs
CONFERENCE CHAIRPERSONS
Dr. Shiow-Ing Wu
Deputy Director-General, Food and Drug Administration, Ministry of Health and Welfare, Taiwan
Ms Estelle Michael
Senior Policy Director, AstraZeneca, United Kingdom
End the conference