9:00 - 9:05 Byoung-guk Kim (MFDS) Welcome Remarks by Program Jin-Ho Wang (Director, 9:05 - 9:10 Opening Address AHC) Byung-Won Jang 9:10 - 9:15 Words of Encouragement (Vice President, MFDS) Won-Bae Kim 9:15 - 9:20 Congratulatory Remarks (Chairman, KPMA) Special Remarks (Program Co-Chair) • Romi Singh (Amgen) Introduction and Outline of the 2013 Biotherapeutics 9:20 - 9:35 • Workshop Soon-wook Hong (MFDS) Keynote Speech 9:35 - 9:50 9:50 - 10:05 Coffee Break & Group Photo Session 1: Overview of Biotherapeutics, and a Roadmap Towards Convergence · Coordinator: Jerry Stewart (Pfizer) · Chair: Yeowon Sohn (MFDS) · Co-Chair: Jerry Stewart (Pfizer) 10:05 Kum Cheun Wong – Biologics vs. Small Molecule Pharmaceuticals (IFPMA) 10:30 Current Development/Regulatory Strategies of 10:30 – Jane Bai (IFPMA) Biotherapeutic Products Key Points to Consider vs. – 10:55 Small Molecules 10:55 Progress and Update on Biosimilars Development in – Hyuk Jae Lee (Celltrion) Korea 11:10 11:10 – Byoung-guk Kim (MFDS) Overview of Biotherapeutic Roadmap 11:30 11:30 – Jerry Stewart (Pfizer) AHC 2012 Biosimilars Workshop Output 11:50 11:50 Biosimilar Regulatory Frameworks with Room for – Judith Macdonald (Pfizer) 12:10 Convergence- what more is needed? Panellists: Session Chairs, 12:10 – Speakers, Conclusion and Q&A, Round Table Discussion 12:40 Invited Participants 12:40 – Luncheon 14:00 Session 2: ICH and WHO Biotherapeutic Considerations for Development of Biologics · Coordinator: Romi Singh (Amgen) · Chair: Ivana Knezevic (WHO) · Co-Chair: HongZhang Yin(CFDA) 14:00 - Development and Implementation of WHO Guidelines Ivana Knezevic (WHO) 14:35 for Regulatory Evaluation of Biotherapeutic Products
9:00 - 9:05 Byoung-guk Kim (MFDS) Welcome Remarks by Program 9:05 - 9:10 Jin-Ho Wang (Director, AHC) Opening Address 9:10 - 9:15 Byung-Won Jang (Vice President, MFDS) Words of Encouragement 9:15 - 9:20 Won-Bae Kim (Chairman, KPMA) Congratulatory Remarks 9:20 - 9:35 Romi Singh (Amgen) • Special Remarks (Program Co-Chair) • Introduction and Outline of the 2013 Biotherapeutics Workshop 9:35 - 9:50 Soon-wook Hong (MFDS) Keynote Speech 9:50 - 10:05 Coffee Break & Group Photo Session 1: Overview of Biotherapeutics, and a Roadmap Towards Convergence · Coordinator: Jerry Stewart (Pfizer) · Chair: Yeowon Sohn (MFDS) · Co-Chair: Jerry Stewart (Pfizer) 10:05 – 10:30 Kum Cheun Wong (IFPMA) Biologics vs. Small Molecule Pharmaceuticals 10:30 – 10:55 Jane Bai (IFPMA) Current Development/Regulatory Strategies of Biotherapeutic Products – Key Points to Consider vs. Small Molecules 10:55 – 11:10 Hyuk Jae Lee (Celltrion) Progress and Update on Biosimilars Development in Korea 11:10 – 11:30 Byoung-guk Kim (MFDS) Overview of Biotherapeutic Roadmap 11:30 – 11:50 Jerry Stewart (Pfizer) AHC 2012 Biosimilars Workshop Output 11:50 – 12:10 Judith Macdonald (Pfizer) Biosimilar Regulatory Frameworks with Room for Convergence- what more is needed? 12:10 – 12:40 Panellists: Session Chairs, Speakers, Invited Participants Conclusion and Q&A, Round Table Discussion 12:40 – 14:00 Luncheon Session 2: ICH and WHO Biotherapeutic Considerations for Development of Biologics · Coordinator: Romi Singh (Amgen) · Chair: Ivana Knezevic (WHO) · Co-Chair: HongZhang Yin(CFDA) 14:00 - 14:35 Ivana Knezevic (WHO) Development and Implementation of WHO Guidelines for Regulatory Evaluation of Biotherapeutic Products