2016年溶出度技术及体内外相关性研讨会日程-中国食品药品检定

2016年溶出度技术及体内外相关性研讨会日程2016年6月20日（星期一）：全天办理注册报到2016年6月21日（星期二）：第一天8:15 – 8:30 开幕式领导致辞8:30-9:15 溶出度技术在仿制药质量研究与生物等效评价中的地位与作用演讲者：中检院专家9:15-10:00 FDA 关于药品研发中溶出度、BE，IVIVC和豁免临床的相关技术指南演讲者：Utpal Munshi 博士（美国FDA BE办公室副主任）10:00 – 10:30: 茶歇10:30 -11:15: 国际溶出技术回顾、动态、及展望演讲者：Erika Stippler 博士（美国药典委员会）11:15 – 12:00: 欧美药品监管机构在溶出技术上的差异和协调努力演讲者：Vivian Gray女士（美国药典委员会委员，美国）12:00 – 12:15 问答主持人：吕旭进博士和中方专家12:15 – 1:15 午餐1:15 – 1:30 美国药学会（AAPS）简介演讲者：Vivian Gray 女士（美国药典委员会委员，美国）1:30-2:15 溶出试验在新药研发中扮演的角色演讲者：Johannes Krämer 博士（美国药典委员会委员，德国）2:15 –3:00 美国FDA对固体口服普通制剂溶出度研究的技术要求（案例分析）演讲者：Jian Hwa Han 博士（AAPS专家，美国）3:00-3:30 茶歇3:30 – 4:15 缓控释制剂质量研究中溶出度方法与技术要求（案例分析）演讲者：吕旭进博士（AAPS溶出度聚焦专家组主席，美国）4:15–5:00 美国药典流池法等溶出度测定方法及应用演讲者：Nikoletta Fotaki博士（AAPS 溶出度聚焦专家组主席，英国巴斯大学）5:00-5:15 问答与讨论主持人：Vivian Gray 女士（美国药典委员会委员，美国）2016年6月22日（星期二）：第二天8:00 – 8:15 回顾首日会议吕旭进博士和中方专家8: 15–9:00 体内外相关性与固体口服制剂的评估演讲者：Johannes Krämer 博士（美国药典委员会委员，德国）9:00 –9:45 USP机械校正和性能验证测试（PVT）演讲者：Erika Stippler 博士（美国药典委员会）9:45 –10:15 茶歇10: 15-11:00 中国药典与溶出度检测演讲者：中方专家11:00 –11:45 机械校正、自动化技术对药品溶出度质量研究的影响演讲者：中方专家11:45 – 12:00 问答与讨论主持人：Nikoletta Fotaki博士（AAPS 溶出度聚焦专家组侯任主席，英国巴斯大学）12:00 – 1:00 Lunch 午餐1:00 – 1:45 FDA固体口服制剂仿制药审评对溶出度研究及相似因子的要求（案例分析）演讲者：Vivian Gray 女士（美国药典委员会委员，美国）1:45–2:30 生物药剂学与仿制药的研发演讲者：Nikoletta Fotaki博士（AAPS 溶出度聚焦专家组侯任主席，英国巴斯大学）2:30-3:00 茶歇3:00-3:45 体外溶出数据、动物和人体药代动力学数据在制剂研发中的应用演讲者：吕旭进博士（AAPS溶出度聚焦专家组主席，美国）3:45-4:30 反映人体生理环境并与临床相关的溶出度标准的建立演讲者：Jian Hwa Han 博士（AAPS专家，美国）4:30 – 4:45 问答与讨论主持人：Johannes Krämer 博士（美国药典委员会委员，德国）4:45-5:00 闭幕式吕旭进博士和中检院专家LECTURE SCHEDULEDay 18:15 – 8:30 Opening remarksXujin and Chinese ChairSession Chair: Xujin and Chinese Chair8:30-9:15 Application of dissolution testing in bioequivalence evaluation of generic drugs Speaker: Chinese regulator9:15-10:00 FDA guidance on dissolution,BE,IVIVC and Biowaver (or relevant topic) for R&D Speaker: Dr.Utpal Munshi (Deputy Director of BE Division,USFDA )10:00 – 10:30: Break10:30 -11:15: Compendial dissolution /drug release testing – overview and updates Speaker: Dr. Erika Stippler, (USP, USA)11:15 – 12:00: Differences and harmonization of CMC area of dissolution, EU/USperspectivesSpeaker: Vivian Gray, V. A. (USP Dosage Forms Expert Committee, Gray Consulting, USA)12:00 – 12:15 Question & answer sessionModerator: Xujin and Chinese Chair12:15 – 1:15 LunchSession Chair: Vivian Gray (USP Dosage Forms Expert Committee, Gray Consulting, USA)1:15 – 1:30 Introduction to American Association of Pharmaceutical Scientists (AAPS) Speaker: Vivian Gray (USP Dosage Forms Expert Committee, Gray Consulting, USA)1:30-2:15 Predictive dissolution testing for development of new drugsSpeaker: Dr. Johannes Krämer, (USP Dosage Forms Expert Committee, PHAST, Germany)2:15 –3:00 Dissolution method development for new drugs in solid dosage formsaccording to FDA Biopharmaceutics’ requirements - case studiesSpeaker: Dr. Jian Hwa Han (AAPS IVRDT FG Steering Committee, Abbvie, USA)3:00-3:30 Break3:30 – 4:15 Dissolution testing for evaluation and approval of new drugs in control or extended release dosage forms - case studiesSpeaker: Dr. Xujin Lu (AAPS IVRDT FG Chair, BMS, USA)4:15–5:00 Various dissolution devices in USP, such as Apparatus 4, with application case studiesSpeaker: Dr Nikoletta Fotaki (AAPS IVRDT FG Chair-Elect, University of Bath, UK)5:00-5:15 Question & answer sessionModerator: Vivian Gray (USP Dosage Forms Expert Committee, Gray Consulting, USA)Day 28:00 – 8:15 Summary of Day1Xujin and Chinese ChairSession Chair: Dr.Nikoletta Fotaki (AAPS IVRDT FG Chair-Elect, University of Bath, UK) 8: 15–9:00 IVIVC According to USP General Chapter <1088> In vitro and In vivo evaluation of dosage formsSpeaker: Dr. Johannes Krämer, (USP Dosage Forms Expert Committee, PHAST, Germany)9:00 –9:45 USP perspective on the Performance Verification Testing and mechanical calibration for USP Apparatus 1 and 2Speaker: Dr. Erika Stippler, (USP, USA)9:45 –10:15 Break10: 15-11:00 Dissolution in Chinese PharmacopeiaSpeaker: Chinese speaker11:00 –11:45 Mechanical calibration and automation and their impact to the quality of dissolution testingSpeaker: Chinese speaker11:45 – 12:00 Q uestion & answer session - Panel discussionModerator: Dr. Nikoletta Fotaki (AAPS IVRDT FG Chair-Elect, University of Bath, UK)12:00 – 1:00 LunchSession Chair: Dr. Johannes Krämer (USP Dosage Forms Expert Committee, PHAST, Germany)1:00 – 1:45 FDA requirements in dissolution testing for evaluation and approval of generic drugs in solid oral dosage forms, including similarity factor - case studiesFDASpeaker: Vivian Gray (USP Dosage Forms Expert Committee, Gray Consulting, USA)1:45–2:30 Biopharmaceutics for generic drug products developmentSpeaker: Dr. Nikoletta Fotaki (AAPS IVRDT FG Chair-Elect, University of Bath, UK) 2:30-3:00 Break3:00-3:45 Dosage and formulation development using animal and humanpharmacokinetics and exploratory pharmaceutics dataSpeaker: Dr. Xujin Lu (AAPS IVRDT FG Chair, BMS, USA)3:45-4:30 Development of biorelevant methods and setting clinically relevantspecifications for dissolutionSpeaker: Dr. Jian Hwa Han (AAPS IVRDT FG Steering Committee, Abbvie, USA)4:30 – 4:45 Question & answer session – Panel discussion 问答与讨论Moderator: Dr. Johannes Krämer (USP Dosage Forms Expert Committee, PHAST, Germany)4:45-5:00 C losing remarksXujin and Chinese Chair。