Programme

WELCOME
Introduction – Update ECA

Dr Afshin Hosseiny, Chairman ECA

GMP PART - 22 June 2021

Moderated by: Lance Smallshaw

SESSION Current GMP Initiatives Worldwide

This session will discuss the latest changes and current initiatives in GMP and GDP regulations.

GMP Update 2021 and Outlook 2022 – Current Trends and Developments in Europe and the US

• Regulation (EU) 2019/6Regulation (EU) Nr. 536/2014
• Reflection paper on Good Manufacturing Practice and Marketing
• Authorisation Holders
• Analytical Procedure Development and Validation (ICH Q14/Q2)
• The new EU GMP Annex 21 on Importation
• GMP Revisions – Annex 1 & 21
• Brexit and its consequences for the European QPs

Dr Bernd Renger, QP and immediate past chair of the EQPA

ICH Q 12: Views and Expectations of a GMP-Inspector

• Quality Risk Management
• Life Cycle Approach
• Views and Expectations

Dr Franz Schönfeld, GMP Inspector

How to Implement ICH Q 12 into Daily Practice of Manufacturers – What QA (and QPs) needs to know?

• What does QA (and QPs) need to consider?
• Some Quality systems become key
• Efficiency potential for Quality systems of manufacturing organizations
• ICH Q12 and key performance indicators
• Plan precisely, assess risks proactively, share transparently

Dr Ulrich Kissel, Chairman European QP Association

Remote/Online Inspection – from the point of view of the Russian Authority

Natalia Burlakina, Russian Federation

The EAEU Academy

Dr Ivan Guliaev, Russian Federation

Global Inspection Management: Cultural Diff erences to consider in hosting Competent Authorities

• General Organisation
• Roles and Responsibilities
• Preparation
• Cultural Aspects

Dr Jens-Uwe Rengers, Zürich, Switzerland

Annex 1 Revision: Comments from the Industry

• New requirements? 
• New requirements!
• The role and improtance of Quality Risk Management 
• Contamintation Control Strategy

Dr Ingrid Walther, Head of ECA´s adhoc Task Force for comments to the Annex 1 revision