英文【EFPIA】幻灯片_通过信任解锁效率——浏览EMA后授权框架

12Agenda1) EMA’s current post-authorization framework (variations) with related tools for reliance (15 min)•Elsie Merken (Scientific Officer Procedures Office, EMA)2) Reliance for PACs in practice (10 min)•Asmaa Fouad (Head of Central Administration of Biological & Innovative Products & Clinical Trials at EDA, Egypt, and representative of EDA in ICH. Advisory member of ECBS-WHO)3) Q&A Session (15 min)Moderator: Andrew Deavin (Senior Director Vaccines Global Regulatory Affairs Asia Pacific & China, Vaccines Europe) Participants:•Elsie Merken (Scientific Officer Procedures Office, EMA) •Victoria Palmi Reig (Senior International Affairs officer, EMA) •Alberto Gañán Jiménez (Head of Committees and Quality Assurance Department, EMA) •Isabelle Colmagne-Poulard (Head of International Global Regulatory & Scientific Policy, Merck) •Susanne Ausborn (Global Head International Regulatory Policy, Roche, EFPIA) •Asmaa Fouad (Head of Central Administration of Biological & Innovative Products & Clinical Trials at EDA, Egypt, and representative of EDA in ICH. Advisory member of ECBS-WHO)•Marie Valentin (Team Lead, Facilitated Product Introduction, Regulation and Prequalification Department, World Health Organisation)4) EMA’s future post-authorization framework (variations) (15 min)•Virginia Rojo Guerra (Head of Procedures Office, EMA)3Agenda5) EMA’s renewal framework (10 min)•Rachel Turner (Scientific Officer Therapies for Endocrine and Cardiovascular Diseases Office, EMA)6) Q&A Session (15 min)Moderator: Isabelle Colmagne-Poulard (Head of International Global Regulatory & Scientific Policy, Merck, EFPIA) Participants:•Elsie Merken (Scientific Officer Procedures Office, EMA) •Virginia Rojo Guerra (Head of Procedures Office, EMA) •Rachel Turner (Scientific Officer Therapies for endocrine and cardiovascular diseases Office, EMA) •Victoria Palmi Reig (Senior International Affairs officer, EMA) •Martin Harvey Allchurch (Head of International Affairs, EMA) •Alberto Gañán Jiménez (Head of Committees and Quality Assurance Department, EMA)•Asmaa Fouad (Head of Central Administration of Biological & Innovative Products & Clinical Trials at EDA, Egypt, and representative of EDA in ICH. Advisory member of ECBS-WHO)•Marie Valentin (Team Lead, Facilitated Product Introduction, Regulation and Prequalification Department, World Health Organisation)•Andrew Deavin (Senior Director Vaccines Global Regulatory Affairs Asia Pacific & China, Vaccines Europe) •Susanne Ausborn (Global Head International Regulatory Policy, Roche, EFPIA)7) Final remarks (5 min)•Martin Harvey Allchurch (Head of International Affairs, EMA) •Susanne Ausborn (Global Head International Regulatory Policy, Roche, EFPIA)Classified as public by the European Medicines Agency EMA post-authorisation frameworkTool to support reliance for variationsClassified as public by the European Medicines Agency Overview• EU Variations Regulatory Framework• Transparency: information published by EMA• EMA procedures and reliance