GMP Part (24 & 25 June 2025)

Welcome

Introduction – Update ECA

Dr Afshin Hosseiny, Chairman of the ECA Advisory Board

 

EMA: Update on Inspections, MRAs and Work Plan

N.N. Brussels

• GMP/GDP Inspectors Working Group – Priorities for 2025 and 2026
• Harmonisation of Inspections in Europe

 

GMP Update 2025 and Outlook 2026 – Current Trends and Developments in Europe and US

Dr Ulrich Kissel

• New concepts and elements in new directive 2023/192/EC
• The EU GMP chapters under revision
• Supply chain reliability and security
• The matters of drug shortages
• Break Through and Prime in relation to ICH Q12

 

EU GMP Annex 11 – The EU Draft Paper

Ib Alstrup & Dr Wolfgang Schumacher

• Compliance requirements vs. challenges for the regulated industry
• Pros and Cons of the draft – practitioner‘s perspective

 

ICH Q9 Trainingspackage: An Overview

Dr Peer Schmidt

• Overview of the ICH Q9 revision
• Hazard identification instead of risk identification
• Formality according to ICH Q9(R1)
• Risks in drug availability
• Risk-based decision-making - a daily task
• Dealing with subjectivity
• The risk review

 

Global Functions in Pharma Large Organizations and EU GMP – A Critical Discussion

Dr Ulrich Kissel

• Why global functions? – characteristics of global function
• How far does EU GMP support global functions?
• Views and experience of the local function
• Gaps, tensions, and conflicts related to the concept of global functions
• A progressive concept to address current limitations

 

Summary Day 1: Impact of the Changes in GMP on the Pharmaceutical Industry

Dr Afshin Hosseiny

 

Click on the picture to open the complete programme as a PDF.