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

SESSION Industry Meets Inspectors

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

Inspection – readiness for new Annex 1: Comments from the Inspector

  • What is essential?
  • What do I need to change or improve?
  • Is it really such serious?

Dr Rainer Gnibl, GMP Inspector

Final Q&A session (Day 1)