Medicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 11th of June in Copenhagen focusing on:
How to Ensure Compliance with EU GMP Annex 1 – a practical perspective.
The EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” came into effect as of August 2023, and companies are now being inspected by the regulatory authorities against the guidelines and are receiving observations in cases of non-compliance. Join us and get a practical perspective on how companies can assess their level of compliance and how to develop and implement a mitigation plan to address any identified gaps. The presentation will include some real-life examples from experiences PharmaLex had with Annex 1 readiness projects.
Topics will include:
• Purpose and key emphasis of Annex 1
• Assessing compliance with Annex 1
• Quality Risk Management
• Contamination Control Strategy
• Lifecycle Management
• Aging facilities
• Lessons learned
Date: Tuesday 11th of June 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Register now
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Company introduction, PharmaLex (becoming Cencora) Nina Andersson, Business Development Manager, Nordic region, PharmaLex |
| 9:15 | How to ensure compliance with EU GMP Annex 1 – a practical perspective Patrick Nieuwenhuizen, Director/Principal Consultant, Quality Management & Compliance, PharmaLex |
| 10:00 | Q&A Session |
| 10:15 | Networking |
| 11:00 | End of Good Morning Meeting |
Patrick Nieuwenhuizen, Director Senior Consultant at PharmaLex
Patrick Nieuwenhuizen has over 25 years of experience in the pharmaceutical industry with a background in microbiology and sterile manufacturing. He has worked for several global pharmaceutical and biotechnology companies, including Genzyme (a Sanofi company) and MedImmune, across a variety of platforms from biologics to sterile fill finish and solid oral dose. Nieuwenhuizen has provided quality, sterility assurance and microbiology oversight for various site and laboratory expansion projects from construction design through to method transfer and operational readiness. Patrick has also been involved in several corporate initiatives, such as a sterility assurance council and the roll-out of corporate standard programs, designed to improve and maintain organizational quality standards. As a lead auditor, he has been involved with audits facing several competent authority inspections, including but not limited to Ireland’s Health Products Regulatory Authority, the U.S. FDA, ANVISA, the Chinese FDA and Health Canada. Acting as a risk facilitator for quality risk management programs, Nieuwenhuizen has gained significant experience with problem-solving and the management of complex investigations.
