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Day1 April 26, 2011(Tuesday)

April 26, 2011(Tuesday) : day01:April 26, 2011(Tuesday), time
09:00 - 09:40 Opening Ceremony
  • Opening Remarks by Dr. Seung Hee Kim
  • Congratulatory Remarks by Dr. Yun Hong Noh
  • Congratulatory Remarks by Dr. Bup Wan Kim
  • Welcome from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) by Dr.Odette Morin
  • Welcome from the Drug Information Association(DIA) by Dr. Yves Juillet
10:00 - 12:00 Plenary Session : Update on ICH Activities, Focus on New Activities
Chair Dr. Sun Hee Lee (Director, Drug Evaluation Department, KFDA)
Chair Dr. Andre W. Broekmans (Vice President, MSD)
20 Years of ICH: Learning and Accomplishments
Speaker Dr. Justina A. Molzon (FDA, USA)
Japan’s Experience with ICH and the Implementation of Guidelines
Speaker Mr. Shinobu Uzu (MHLW, Japan)
Expanding Participation in ICH Technical Working Groups to Regional Harmonization Initiatives (RHIs) and Drug Regulatory Agencies (DRAs)
Speaker Mr. Mike Ward (Chair, APEC RHSC)
KFDA’s Perspectives on the Implementation of ICH Guidelines
Speaker Dr. Sun Hee Lee (Drug Evaluation Department, KFDA)
13:00 - 15:30 Plenary Session : Regional Harmonization Initiatives
Chair Dr. Justina A. Molzon (Chair, APEC RHSC Subcommittee on Training)
Chair Ms. Weon Do (Head of Regulatory Affairs and Market Access. Sanofi-Aventis)
The Role of APEC in Advancing Harmonization Efforts in a More Strategic, Effective and Sustainable Fashion
Speaker Mr. Mike Ward (Chair, APEC RHSC)
AHC Activities: Current Status and Future Prospects
Speaker Dr. Kui Lea Park (KFDA)
ASEAN Regulatory Harmonization Activities and Future Perspectives
Speaker Dr. Yuppadee Javroongrit (FDA, Ministry of Public Health, Thailand)
Tripartite Symposium on Rationalization of Clinical Trial Requirements
Speaker Ms. Hee Young Park (KFDA)
Mr. Shinobu Uzu (MHLW, Japan)
Dr. Li Jinju (SFDA, P.R. China)
16:00 - 17:30 PARALLEL TRACKS

  • TRACK 1: Fighting Counterfeit Medicines in Emerging Countries: Addressing Infrastructure And Capacity Gaps
    Chair Dato’ Eishah A. Rahman (Senior Director,
    Pharmaceutical Services Division, Ministry of Health, Malaysia)
    Chair Mr. Arun Mishra (Director, Global Regulatory Affairs, GlaxoSmithKline, UK)
    Counterfeit Medicines in Asia Today
    Speaker Mr. Thomas Kubic (the Pharmaceutical Security Institute, USA)
    The Malaysian Experience with Meditag
    Speaker Dato’ Eishah A. Rahman (Ministry of Health, Malaysia)
    Singapore’s Experience in the Fight Against Counterfeits
    Speaker Ms. Ruth Lee Choo Ai (HSA, Singapore)

  • TRACK 2: Ensuring Quality - Enhance the Approach of Quality Driven by ICH Q8, Q9, Q10, and Q11: What about Practical Implementation
    Chair Dra. Kustantinah (Head, NA-DFC/BPOM, Indonesia)
    Chair Dr. Geroges France (Vice President, Pfizer, UK)
    ICH Q-IWG Updates and Challenges
    Speaker Dr. Geroges France (Pfizer, UK)
    Speaker Dr. Jean-Louis Robert (National Health Laboratory,Luxembourg)
    CMC Requirements to Support New Technology in Development and Analytical Methods (e.g. NIR, UPLC)
    Speaker Dr. Moheb Nasr (FDA, USA)
    Validation and Continuous Verification: Regulatory Challenges
    Speaker Dr. Yukio Hiyama (MHLW, Japan)

  • TRACK 3: Practical Uses of Common Technical Documents (CTDs) in Asia
    Chair Dr. Lembit Rago (Coordinator, QSM, WHO, Switzerland)
    Chair Mr. Kum Cheun Wong (Director, Global Regulatory Policy & Intelligence,
    Asia Pacific, Johnson & Johnson, Singapore)
    Experience and Value of CTD
    Speaker Ms. Jalene Poh (HSA, Singapore)
    Practical Use of ICH CTD in Facilitating Approval of Prequalification of Pharmaceutical Products and the Benefits to the WHO Program
    Speaker Dr. Lembit Rago (WHO, Switzerland)
    Practical Use and Value of CTD in Clinical Trials and New Drug Application (NDA), and Challenges Faced in the Asia Region
    Speaker Mr. Alistair Davidson (PPD, UK)

Day2 April 27, 2011 (Wednesday)

day02: April 27, 2011 (Wednesday) : day02: April 27, 2011 (Wednesday): time
08:30 - 10:00 Plenary Session : Early Clinical Development in Asia
Chair Professor In-Jin Jang (Seoul National University, Republic of Korea)
Chair Dr. Ajmeer Ramkishan (Asst. Drugs Controller, CDSCO, Sub Zonal Office, India)
Current Status of Early Clinical Development in Asia and Plan for the Future: Industry Perspective
Speaker Dr. Ken Kobayashi (Johnson & Johnson, Japan)
Regulatory Experience in Early Clinical Trial Approval
Speaker Dr. Ajmeer Ramkishan (CDSCO, Sub Zonal Office, India)
How Asian Clinical Sites are Working for Early Clinical Trials
Speaker Professor In-Jin Jang (Seoul National University, Republic of Korea)
10:30 - 12:30 Plenary Session : Late Clinical Development in Asia
Chair Dr. Herng-Der Chern (Distinguished Researcher, CDE, Chinese Taipei)
Chair Mr. Adrian Waterson (Asia Regulatory Director, AstraZeneca, UK)
Simultaneous Multi-regional Clinical Trials
Speaker Dr. Moira Daniels (AstraZeneca, UK)
Acceptance of Clinical Data - The Challenge of Generalizability
Speaker Dr. Yuki Ando (PMDA, Japan)
Towards Simultaneous Regulatory Approval
Speaker Dr. Herng-Der Chern (CDE, Chinese Taipei)
13:30 - 15:30 PARALLEL TRACKS

  • TRACK 1: Establishing the Asia Pacific Region as an Important Partner in Global Pediatric Development
    Chair Dr. Min Soo Park (Director, Clinical Trials Center, Chair, Department of Clinical Pharmacology, Yonsei University, Republic of Korea)
    Chair Mrs. Angelika Joos (Head, Regulatory Policy, MSD (Europe), Belgium)
    Participation in Asia in Global Pediatric Programs, Including Cultural Barriers to Conduct Pediatric Clinical Trials
    Speaker Dr. Hidefumi Nakamura
    (National Center For Child Health and Development, Japan)
    How to Extrapolate Clinical Development Results to Asia Children: Usefulness of Bridging the Program with Adults
    Speaker Dr. An Vermeulen (Johnson & Johnson, Belgium)
    FDA’s Experience With Global Pediatric Development
    Speaker Dr. Jean W. Temeck (FDA, USA)
    Position of WHO ICDRA on Global Pediatric Development
    Speaker Ms. Agnes Chan (HSA, Singapore)

  • TRACK 2: Ensuring Quality: Harmonizing and Optimizing Inspection Approach in the Global Environment
    Chair Dr. Yukio Hiyama (Chief, Third Section, Division of Drugs, MHLW, Japan) Chair Dr. Georges France (Vice President, Global Quality Strategy and IAQC, Pfizer UK)
    Control Strategy and Batch Release: Challenges for a Global and an Harmonized Approach
    Speaker Dr. Jacques Morenas (AFS-SAPS, France)
    Quality Risk Management in the WHO Prequalification Process
    Speaker Dr. Lembit Rago (WHO, Switzerland)
    API: Role of EDQM in Globalization, Input on Inspections and Standards
    Speaker Dr. Susanne Keitel (EDQM, Council of Europe, France)
    Panel Discussion: CMC Harmonization and Regulatory Challenges
    Chair Dr. Georges France (Vice President, Global Quality Strategy and IAQC, Pfizer UK)
    Panelists Dr. Moheb Nasr (FDA, USA)
    Dr. Yukio Hiyama (MHLW, Japan)
    Dr. Jacques Morenas (AFS-SAPS, France)
    Dr. Lembit Rago (WHO, Switzerland)
    Dr. Susanne Keitel (EDQM, Council of Europe, France)
    Dra. Kustantinah (NA-DFC/BPOM, Indonesia)

  • TRACK 3: Ethical Business Practices: Towards Better Marketing Compliance
    Chair Dr. Megan Keaney (Principal Medical Adviser, TGA, Australia)
    Chair Mr. In-Bum Kim (Sr. Director, KRPIA, Republic of Korea)
    Latest Developments on Ethical Business Practices (EBP) in Australia
    Speakers Dr. Megan Keaney (TGA, Australia)
    Ms. Deborah Monk (Medicines Australia, Australia)
    Update on New RDPAC Code and Latest Developments in China
    Speaker Ms. Jennifer Chen (RDPAC, P.R. China)
    Code Compliance Governance in Japan
    Speaker Mr. Yota Kikuchi (Sanofi-Aventis, Japan)

April 28, 2011 (Thursday)

day03:April 28, 2011 (Thursday) : day03:April 28, 2011 (Thursday), time
08:30 - 10:00 Plenary Session : Electronic Submissions and eCTD as Vehicle to Reconcile Differences in Technical Regulatory Requirements
Chair Mr. Gary M. Gensinger (Deputy Director, Office of Business Informatics, CDER, Food and Drug Administration)
Chair Mr. John W. Kiser (Senior Director, Global Pharmaceutical Regulatory Affairs, Abbott Laboratories, USA)
The Advantages and Challenges of Electronic Regulatory Submissions in eCTD and Non-eCTD Electronic Submissions (NeeS) Formats - An Industry Perspective
Speaker Mr. John W. Kiser (Abbott Laboratories, USA)
Benefits to Implementing eCTD - A Regulatory Perspective
Speaker Mr. Gary M. Gensinger (CDER, FDA, USA)
Practical Use and Challenges Faced -An Asia Regular Perspective
Speaker Ms. Jalene Poh (HSA, Singapore)
10:30 - 12:30 Plenary Session : Pharmacovigilance: How Do Regulatory Agencies and Industry Work Together to Protect Patients?
Chair Dr. Suzette Henares-Lazo (Acting Director IV, FDA, Philippines)
Chair Dr. Paul Eisenberg (Senior Vice President, Amgen, USA)
Current Status and New Directions for Pharmacovigilance in Korea
Speaker Dr. Joungwon Oh (KFDA, Republic of Korea)
Integrating Risk Management into Global Drug Develop¬ment - Opportunities and Challenges
Speaker Dr. Paul Eisenberg (Amgen, USA)
Post-Marketed Surveillance - A Shared Responsibility
Speaker Dr. Rebecca Wang (Roche, P.R. China)
The Role of MedDRA in Pharmacovigilance Activities
Speaker Dr. Patricia Mozzicato (MSSO, USA)
01:30 - 03:00 Plenary Session : Good Regulatory Practices, Including Assessment Report, Efficient Use of Certificate of Pharmaceutical Product (CPPs) and Transparency
Chair Dr. Megan Keaney (Principal Medical Adviser, TGA, Australia)
Chair Dr. Yves Juillet (DIA President Elect, Senior Advisor, LEEM, France)
Good Regulatory Practices: Do We Have a Common Understanding?
Speakers Dr. Yoshiaki Uyama (PMDA, Japan)
Opportunities for Industry to Partner with Drug Regu¬latory Authorities (DRAs) to Further Good Regulatory Practices
Speakers Dr. Romi Singh (Amgen, USA)
Efficient Use of CPPs
Speakers Dr. Lembit Rago (WHO, Switzerland)