ISPE Announces a Regulatory Focus at the 2024 ISPE Europe Annual Conference with Health Authority Representatives from the US, United Kingdom, and Europe
The 2024 ISPE Europe Annual Conference will occur on 16-18 April in Lisbon, Portugal, and virtually.
ISPE has announced a regulatory focus with speakers from global health authorities and industry leaders at the 2024 ISPE Europe Annual Conference, including the Europe Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), the Therapeutic Goods Administration (TGA), Infarmed - National Authority of Medicines and Health Products, the Swiss Agency for Therapeutic Products (SwissMedic), and the US Food and Drug Administration (US FDA).
The 2024 ISPE Europe Annual Conference is one of ISPE’s largest conferences of the year, which will gather pharmaceutical professionals worldwide. The event will feature a global regulatory presence and offer countless networking opportunities to collaborate with peers, engage with thought leaders, explore innovative ideas, and forge connections to influence professional journeys.
“This event offers endless possibilities for our industry, building on the remarkable transformations I have witnessed throughout my extensive experience and involvement with ISPE,” said 2024 ISPE Europe Annual Conference Executive Chair Udo Vetter, Head of the Advisory Board, Vetter Pharma International GmbH. “Following the tremendous success of last year's event, this year promises to be equally exceptional.”
Regulatory Focus
Rick Friedman, Deputy Director, Office of Manufacturing Quality, FDA/CDER, will provide the FDA regulatory keynote on Tuesday, 16 April. Later in the day, he will join a panel discussion, “Harmonization to Break Down Barriers to Robust Supply Chains.”
On Wednesday, 17 April, Evdokia Korakianiti, Head of Quality and Safety of Medicines, EMA, will provide the EMA regulatory keynote. Kevin J. Bailey, GMP Inspector, MHRA, and Ian Jackson, Unit Manager, Inspection Risk, Control and Governance, MHRA, along with Francisco Vicenty, Program Manager, Case for Quality, FDA/CDRH/OPEQ and Daniel Walter, Policy Analyst FDA/CDRH/OPEQ, will participate in a regulatory panel discussion. The discussion will focus on the implications and opportunities with Computer Software Assurance (CSA) draft guidance and GAMP® 5 (Second Edition), produced by ISPE, on 21 Code of Federal Regulations (CFR) Part 11. Inspection case studies from TGA and MHRA will also be presented on 17 April.
“Drug Shortage Prevention: Where are We?” will cover regulatory trends and drug availability, presented by Jessica L. Hale, Associate Director-US and Global Regulatory Affairs, Merck & Co. Inc., and Diane L. Hustead, Executive Director, Regulatory Affairs Merck & Co., Inc. (lead authors of the ISPE Drug Shortages Prevention Model). A panel discussion on drug shortages will take place on Thursday, 16 April, as well.
Confirmed Health Authority and Industry Keynote Speakers
Additional Highlights
The event will feature a conversation with Michelangelo Canzoneri, Global Head of Group Smart Manufacturing, Merck KGaA Darmstadt, Germany, and Daniele Iacovelli, Senior Vice President, Global Head of Digital, Analytics, and Operational Excellence, F. Hoffman-La Roche, entitled “Operations Excellence Meets Digital: Miss the Shift, Miss the Future – Merck and Roche Sharing Experiences.”
Additionally, Rui Santos Ivo, PharmD, President, Infarmed, will give remarks on Tuesday, 16 April, and Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk, will provide remarks on Wednesday, 17 April.
Breakout sessions and panel discussions will feature industry case studies on:
- Digital Transformation: Use Cases, Key Benefits, and Lessons Learned
- Learnings from Good Practice (GxP) Inspections to Prepare for the Future
- Regulatory Restrictions and Drug Availability
- Good Engineering Practice and Efficient Investment Management
- GAMP® 5