GMP & GDP Forum 2023
Agenda Day 1: GMP Forum | 20 June 2023
Welcome
Introduction – Update ECA
Dr Afshin Hosseiny, Chairman of the ECA Advisory Board
Moderator
Dr Ulrich Kissel
Session 1: Current GMP Initiatives and Trends
This session will discuss the latest changes and current initiatives in GMP and GDP regulations.
GMP Update 2023 and Outlook 2024 – Current Trends and Developments in Europe and US
Dr Bernd Renger
- Regulation (EU) 2019/6 on Veterinary Medicinal Products – short feedback about the reduction of the use of antibiotics
- Revised Directive (EU) 2017/1572 on GMPs for Medicinal Products & Delegated Regulation (EU) 2017/1569 & revised Annex 13 – short feedback about the differences of „human use Medicinal Products“ and „IMPs“
- Reflection Paper GMP and Marketing Authorisation Holder (MAH) – Experiences
- Revision of Annex 1 – Feedback from the industry
- New Annex 21 – Experiences
- Concept Paper Annex 11 – Goals of the revision
- ICH Q2(R2) und ICH Q14 – Life Cycle of Analytical Procedures – Current status and feedbacks from the industry
- Nitrosamines in Medicinal Products and APIs – Trouble for industry and authorities?
EMA: Update on Inspections, MRAs and Work Plan
Andrei Spinei
- RIS Inspection System
- GMP/GDP Inspectors Working Group – Priorities for 2023 and 2024
- MRA current status and future activities
- Harmonisation of Inspections in Europe
Session 2: Industry Meets Inspectors on Hot GMP Topics
Part A – The Revision of ICH Q9 Risk Management
ICH Q 9 Revision: Inspector´s view
Dr Rainer Gnibl
- Overview
- What is new?
- Consequences in practice
Industry View: What does the ICH Q9 Revision mean for manufacturers ?– What QA (and QPs) need to know?
Dr Peer Schmidt
- Background of guideline revision
- Key changes
- Impact on manufacturers
- Examples for application
Part B – EU GMP Annex 11 on Computer Validation – EU Concept Paper on the upcoming Revision
EU GMP Annex 11 – The EU Concept Paper
Ib Alstrup
- History of Annex 11
- Why now a new version
- Concept Paper
EU GMP Annex 11 – Industry view
Dr Wolfgang Schumacher
- Importance of Annex 11 for the Pharmaceutical Industry
- Industry view on Annex 11 Concept Paper
Part C – The New EU GMP Annex 1 – Consequences for QA
Annex 1 Revision: What does Industry has to expect? - GMP-Inspector´s view
Dr Rainer Gnibl
- Contamination Control Strategy
- (Re-) Qualification
- Barrier Technologies & „old“ clean air equipment
- News in material transfer
- Sterile Filtration
- Worst case for Aseptic Process Simulation
Annex 1 Revision: Relevant Points for QA – Industry view
Dr Ingrid Walther
- Increasing relevance of Quality Risk Management
- Contamination Control Strategy
- Trending – the new Trend!