International Conference for Future Trends of Generic Drug Taipei 29-30 May, 2014 Day 1: Thursday, 29 May 2014 Time Subject 08:30-09:20 Registration 09:20-09:30 Opening/ Welcome Speech (Group Photo) Speakers /Rapporteurs Ming-Kung Yeh Director General Food and Drug Administration (TFDA), Ministry of Health and Welfare SessionⅠ. Overview of Global Generic Regulatory Evaluation 09:30-09:40 Moderator: Churn-Shiouh Gau Chief Executive Officer, Center for Drug Evaluation 09:40-10:10 10:10-10:30 10:30-10:50 10:50-11:20 11:20-11:50 Future of Generic Medicines Regulation Mike Ward International Cooperation on Biowaiver W. Craig Simon Manager International Programs Division of the Therapeutic Products Directorate of Health Canada Associate Director International Programs Division of the Therapeutic Products Directorate of Health Canada Tea Break Generic Drug Regulation Overview in Japan Ryosuke Kuribayashi The EU’s Decentralized Procedure Peter Bachmann Reviewer, Pharmacist Division of Generic Drugs, Office of OTC/Generic Drugs Pharmaceuticals and Medical Devices Agency (PMDA) Unit Head European and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM) 11:50-12:10 Panel Discussion / Q & A Churn-Shiouh Gau Chief Executive Officer Center for Drug Evaluation 12:10-13:30 Lunch Session Ⅱ. Trends of Generic Related Regulation 13:30-13:40 Moderator: Churn-Shiouh Gau Chief Executive Officer, Center for Drug Evaluation 13:40-14:10 Assessment of APIs in Europe: ASMF & CEP Hélène Bruguera Head of Certification Division, European Directorate for the Quality of Medicines & HealthCare (EDQM) 14:10-14:40 The Requirements of a CEP in Lieu of Mariana Gebara Coghlan a DMF for a Drug Substance – TGA Director Pharmaceutical Chemistry Section, Office of Scientific Evaluation Perspective 14:40-15:10 Drug Master File-Key Aspect of Industry Therapeutic Goods Administration (TGA) 15:10-15:30 15:30-16:30 16:30-17:00 Tea Break Global Trend of Biowaivers Biowaivers, Biopharmaceutical Classification System Biowaivers in Taiwan Ya- Ching ChangChien Assistant Vice President Standard Chem.&Pharm. Co., Ltd. Alfredo Garcia Arieta Head of Service on Pharmacokinetics and Generic Medicines, Human Use Medicines, Division of Pharmacocology, Service on Pharmacokinectics and Generic Medicines (AEMPS) Li-Heng Pao Associate Professor Chang Gung University of Science and Technology 17:00-17:20 Panel Discussion / Q & A Churn-Shiouh Gau Chief Executive Officer Center for Drug Evaluation International Conference for Future Trends of Generic Drug Taipei 29-30 May, 2014 Day 2: Friday, 30 May 2014 Time Subject Session Ⅲ. Generic Regulation for Industry 09:00-09:20 Moderator: Weng-Foung Huang Speakers /Rapporteurs Professor, Institute of Health and Welfare Policy, National Yang-Ming University 09:20-09:50 GDUFA and Its Effect Chun-Chang Fang Regulatory Consultant Chem-Rite Professional Group, Thousand Oaks, CA 09:50-10:20 10:20-10:40 10:40-11:10 11:10-11:40 11:40-12:00 Actions for Improvement of Reliability in Japan Generics Manufacturers Tea Break Regulatory Expectation and Quality Management Requirements In Conducting BE Studies Oral Thin Films – New Strategies & Opportunities Satoru Nagamura Panel Discussion / Q & A Weng-Foung Huang General Manager Quality Assurance Dept., Towa Pharmaceutical Co., Ltd. Toong-Chow Lee Managing Director Info Kinetics, Clinical Research Centre Catherine Lee Director TAHO Pharmaceuticals Ltd. Professor Institute of Health and Welfare Policy, National Yang-Ming University 12:00-13:30 Lunch Session Ⅳ. Trends of Markets 13:30-13:40 Moderator: Weng-Foung Huang Professor, Institute of Health and Welfare Policy, National Yang-Ming University 13:40-14:10 Current Progress of the Generics Ye-Su Chao Market in Taiwan Program Director 14:10-14:40 Review and Market Trends Europe Development Center for Biotechnology (DCB) Adrian van den Hoven Director General European Generic Medicines Association (EGA) 14:40-15:10 Generic Market and Policy of Generic Takeshi Hishikura Industry and Current Status in Japan Director of International Affairs 15:10-15:30 15:30-16:00 Tea Break Recent Progress in Generics Market in ASEAN Ming-Loong Cheah Panel Discussion / Q & A Weng-Foung Huang Japan Generic Medicines Association (JGA) 16:00-16:20 General Manager Kotra Pharma (M) Sdn. Bhd., Represents Malaysian Organization of Pharmaceutical Industry (MOPI) Professor Institute of Health and Welfare Policy, National Yang-Ming University 16:20-16:30 Closing Speech Hsueh-Yung (Mary) Tai Deputy Director Division of Medicinal Products, Food and Drug Administration (TFDA), Ministry of Health and Welfare
© Copyright 2024 ExpyDoc
