Talk CMC & Product Quality track
S0201 - Global Partnerships to Accelerate Availability of Quality Medicines
Wed, Mar 19, 2025 · 8:30–9:40 AM CET San Francisco Room, Congress Center Basel
About this session
The session will provide an overview of the ICMRA's Pharmaceutical Quality Knowledge Management project. There will be a detailed discussion on the learnings from the ICMRA PQKM pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities. The session will also discuss how such pilots could be leveraged with other international collaboration programmes for a positive impact on global supply.
Programme:
- 4. ICMRA PQKM Collaborative Assessment and Inspection Pilots – Industry Perspective — Hugo Ta
- Panel Discussion — Marie Valentin, Yasuhiro Kishioka, Christian Schärer, Ian Jackson
- 5. The power of reliance - Leveraging EMA as reference agency for PACs — Susanne Ausborn
- 3. ICMRA Collaborative Hybrid Inspection (CHIP) — Brendan Cuddy
- 1. Supporting regulatory convergence and reliance through Pharmaceutical Quality Knowledge Management — Lorraine Nolan
- 2. Global Partnerships to Accelerate Availability of Quality Medicines — Evangelos Kotzagiorgis
- 0. Welcome and Introduction — Evdokia Korakianiti
- Take 5 – Global Partnerships to Accelerate Availability of Quality Medicines — Mark Pellett
Speakers
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Expert GMP Inspector · MHRA
Panelist
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Pharmaceutical Quality Senior Specialist, Pharmaceutical Quality Office, Human M · European Medicines Agency
Speaker
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Chief Executive · Health Products Regulatory Authority
Speaker
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Reviewer Director, Office of Cellular and Tissue-based Products · Pharmaceuticals and Medical Devices Agency (PMDA)
Panelist
