The CEP procedure plays a vital role in protecting public health, ensuring regulatory efficiency and promoting global harmonisation and helps to build and maintain trust in the pharmaceutical field around the world. This conference took a deep dive into the latest developments in this fast-moving regulatory environment and explore what the future holds for the CEP procedure.
Target audience
This conference is of interest to professionals from the pharmaceutical or chemical industry, regulatory agencies and academic institutions.
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Opening session
- Welcome address, Andrea Cseh-Pálos, National Center for Public Health and Pharmacy (NNGYK)
- Keynote speech: Building Trust in a Challenging Public Health Environment, Hiiti Sillo and Marie Valentin, World Health Organization (WHO)
Session I: Navigating CEP 2.0: a game changer
- CEP 2.0: where do we stand today, Andrea Melloni, EDQM, Council of Europe
- CEP 2.0: the CEP holder’s perspective, Himali Ujagare, Cipla
- CEP 2.0: the pharmaceutical industry perspective, Karina Boszko, Medicines for Europe
- CEP 2.0: the regulatory authorities’ perspective, Zuzana Fliegerová, State Institute for Drug Control (SUKL)
- CEP 2.0: the regulatory authorities’ perspective, Richard Weissmahr, Swissmedic
Session II: Get ready! New developments on the horizon
- Applying modern technologies to well-established APIs, Stéphanie Girard, Seqens
- Modernising the CEP procedure, Hélène Bruguera, EDQM, Council of Europe
- Finding your way with the new eCTD (ICH-M4Q), Ivica Malnar, Agency for Medicinal Products and Medical Devices (HALMED)
- Exploring the use of AI at EDQM, Hans-Joachim Bigalke, EDQM, Council of Europe
Session III: The power of GMP inspections
- The EDQM Inspection programme: the past, present and future, Thomas Hecker, EDQM, Council of Europe (Slides are not available)
- International Collaboration GMP inspections of API manufacturers, Phillip Arntz, European Medicines Agency (EMA)
- The role of PIC/S to enhance inspections of API manufacturers globally Hirofumi Suzuki, PMDA secondee at Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Session IV: Maximising the potential of CEPs
- Relying on CEPs: Egyptian Drug Authority’s perspective, Mohamed Badawi Nour Eldin, Egyptian Drug Authority (EDA)
- Reliance is the key: perspective of WHO and good reliance practices, Marie Valentin, World Health Organization (WHO)
- CEP acceptance: a global achievement (Industry views), Melanie Ramsimmer, Active Pharmaceutical Ingredient Committee (APIC)
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