戻る Agenda
Session 3: ELECTRONIC AND PHARMACOVIGILANCE TOPICS
Session Chair(s)
Joerg Schnitzler, PHARMD, MSC, RPH
Head of Global Regulatory Operations
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Growing needs for efficient handling of regulatory information require innovative electronic standards. Ten years after the successful introduction of eCTD v3.2.2 the M8 Expert Working Group (EWG) is currently working on the next major version of eCTD introducing v4.0 as a versatile exchange standard for electronic regulated product submissions. The M2 EWG provides in this context the framework for the development of new electronic ICH standards involving Standards Developing Organisations (SDOs). In parallel M2 currently evaluates, under its original mandate, future document standards for regulatory information addressing requirements for more structured information. Latest Pharmacovigilance activities include the preparation of a Q&A regarding the implementation and technical maintenance of the “Periodic Benefit / Risk Evaluation Report”, which the E2C(R2) Implementation Working Group (IWG) worked on after successfully reaching Step 4 in May 2013.
Speaker(s)
M2 Electronic Standards for the Transfer of Regulatory Information
Stan A van Belkum, MSC
Medicines Evaluation Board, Netherlands
Deputy Director
M8 The Electronic Common Technical Document
Joerg Schnitzler, PHARMD, MSC, RPH
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Head of Global Regulatory Operations
E2C (R2) Periodic Benefit / Risk Evaluation Report
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety