2018 CCFDIE-ISPE China Conference Agenda

Transcription

1 2018 CCFDIE-ISPE China Conference Agenda Oct 16 Morning Oct 16 Afternoon Plenary meeting Center for Food and Drug Inspection Session Oct 17 Morning Oct 17 Afternoon Forum A Oversea Regulation Updates Forum D New Trends in Drug Research and Development Forum B Continuous Manufacturing Forum E Production and Engineering Forum C Quality Control of Cell Therapy Products Forum F Clinical Supply Management Oct 18 ICH Q7 Seminar

2 Plenary meeting Oct 16 Morning 09:00-09:15 Opening Ceremony 09:15-09:45 09:45-10:15 Drugs Production Safety Trend in China Department of Food Safety Supervision, CFDA New measures for FDA drug regulation FDA 10:30-11:00 11:00-11:30 11:30-12:00 New measures for EU drug regulation EMA New measures for Japan drug regulation PMDA Oct 16 Afternoon Center for Food and Drug Inspection Session 13:30-14:15 14:15-15:00 Annual Inspection Report of Drugs Production Safety Overseas Inspection 15:00-15:15 Break 15:15-16:00 16:00-16:45 Unannounced Inspection Drug Clinical Trial Supervision in China 16:45-17:10 Q&A

3 Forum A Oversea Regulation Updates Host Ningning Ma, Jim Lambert Oct 17 Morning 08:30-09:00 09:00-09:35 09:35-10:15 Sartorius American Regulation Update Jim Lambert, CAI vice president EU Regulation Update ISPE Headquarters Specialist 10:30-11:00 11:00-11:30 11:30-12:00 New Development of ICH ISPE Headquarters Specialist Research on the Implementation of ICH in China Department of International Cooperation, CFDA Application of ICH Q5 in Biopharmaceuticals Ningning Ma, Professor, Shenyang Pharmaceutical University 12:00-12:20 Panel Discussion Forum B Continuous Manufacturing Host Eli Lilly 08:30-09:00 09:00-09:30 09:35-10:15 Truking Inspection Perspective on the Application of Emerging Technology Development and Application of Continuous Manufacturing Lilly Scientist 10:30-11:15 11:15-11:45 Regulatory and Science View on Continuous Manufacturing Authority Officer, Regulatory Requirement for Continuous Manufacturing and the Concern for on-site Inspection Lilly Scientist 11:45-12:15 Q&A

4 Forum C Quality Control of Cell Therapy Products Host Richard Wang, CEO, Fosun Kite Biotechnology Co., Ltd 08:30-08:50 08:50-09:10 09:10-9:40 09:40-10:00 Consideration of Onsite Inspection for Cell Therapy Products Quality Control of Raw/Excipients and Process Validation for Cell Therapy Products Center for Drug Evaluation, CFDA The Importance of GMP Inspection of Cell Therapy Products Shanghai Center for Drug Evaluation and Inspection Inspection of Cell Therapy Products FDA Specialist of Cell therapy products 10:00-10:15 Break 10:15-10:35 10:35-10:55 10:55-11:15 Novartis pharmaceutical Inspection Experiences Sharing of Yescarta Mehrshid Alai-Safar, Kite pharmaceutical GE Healthcare 11:15-12:20 Panel Discussion Significance of industrialization for cell therapy products quality Oct 17 Afternoon Forum D New Trends in Drug Research and Development Host Long Cheng, PAREXEL 13:30-14:00 14:00-14:30 14:30-15:00 New Era Coming-Data Driven Drug Research and Development Application of National Health Care Big Data Platform Hui Xiao, Vice President, China Electric Data Service Co., Ltd Review of Real-world Evidence and Adaptive Clinical Design by CDE Center for Drug Evaluation, CFDA 16:15-16:45 16:45-17:20 Standardizing the Use of Real World Research Data in Drug Regulation (Pharmacovigilance and Generic Drug Evaluation) Center for Reevaluation, CFDA Full Cycle Evaluation of Drugs Based on Clinical Value Long Cheng, PAREXEL Clinical Cohort Study of Cancer Based on Medical Information Registration System Naiqing Zhao, Professor, Fudan University

5 17:20-17:35 Panel Discussion Forum E Production and Engineering 主持人 :Ping Zhang, Sanofi 13:30-14:00 14:00-14:30 14:30-15:00 MAH introduction in US and EU Daniel Zang, Sanofi China Quality Culture Xuelin Yin, Boehringer Ingelheim Application of ICH Q7 in API production Ervin Vajda, Sanofi Hungary 16:15-16:45 16:45-17:15 Impact of Process Induced Phase Transitions on the Pharmaceutical Formulation Jun Han, Shandong Liaocheng University Computerized System Validation Life Cycle Ping Niu, Abbott Highly Toxic Products Shared Lines 17:15-17:35 Panel Discussion Forum F Clinical Supply Management Host Lin Wang 13:30-14:00 14:00-14:30 14:30-15:00 Interpretation of CFDA draft regulation GMP for CTM for public comments China Regulation of GMP on Clinical Trial Materials: Practice in real life by Catalent Leo Zhang, Head of APAC Quality, Catalent Regulatory, Clinical and Logistics Challenges of ATMPs(Cell and Gene Therapies)in Clinical Research Andress Zobel, Senior Director, PAREXEL global clinical trail supply 16:15-16:45 China Regulatory Requirement and EC Review and Approval Related to Clinical Supply Li Yang, Director, Peking University Third Hospital Department of Pharmacy Regulatory, Clinical, Technology and Logistics Challenges of Direct to Patient Studies Jeff Ten, Head of clinical trial supply in APAC, PAREXEL

6 16:45-17:15 Panel Discussion ICH Q7 Seminar Oct 18 Morning 08:30-08:40 08:40-09:40 09:40-10:15 Welcome & Introduction What does ICH Q7 Intend to Guide? Stephan Ronninger EWG Expert Distribution (GDP of ICH Q7) Stephan Ronninger EWG Expert 10:30-11:30 11:30-12:00 Review and Interpretation of Important Chapters of ICH Q7 Dinesh Khokal EWG Expert Data Integrity in ICH Q7 Dinesh Khokal EWG Expert ICH Q7 Seminar Oct 18 Afternoon 13:00-14:00 14:00-15:00 WHO Inspectors Perspective on GMP of APIs WHO CFDI Inspectors Perspective on GMP of APIs Including Comparison of ICH Q7 and Chinese GMP Oversea GMP Inspection (Including API) 16:15-17:15 Local Company Perspective on GMP of APIs and Experience Sharing Fosun Pharma Recent Quality topics in the Implementation of GMPS for APIs RDPAC 17:15-17:30 Q&A Session