ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
FDA on Regulatory Reliance and Agility
Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US FDA’s Center for Drug Evaluation and Research, opened the 2024 ISPE Annual Meeting & Expo in Orlando, Florida with a keynote presentation about international efforts to improve pharmaceutical availability by increasing regulatory agility and reliance.
EMA on the Future of Innovation and Regulation
Emer Cooke, European Medicines Agency Executive Director and chair of the International Coalition of Medicines Regulation Authorities participated in a in a fireside chat during the 2024 ISPE Meeting & Expo. The discussion centered on the opportunities and challenges faced by regulatory agencies and the pharmaceutical industry in maintaining collaboration post-Covid-19, fostering innovation, and overcoming barriers to global harmonization. READ MORE
ISPE Global Regulatory Town Hall: The Future is Now
The theme of the Global Regulatory Town Hall held at the 2024 ISPE Annual Meeting & Expo was “The Future is Now” with industry and regulatory panellists addressing harmonization and regulatory convergence, digitalization, the use of artificial intelligence (AI), supply chain resilience, and digital platforms that are shaping the future of pharmaceutical development and commercialization.
Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
Industry experts and regulators participated in a candid a candid exchange of experiences and ideas to address the challenges of implementing recent guidelines at a session at the 2024 ISPE Annual Meeting & Expo. Topics included platform analytical procedures, enhanced approaches to development practices, change management utilizing the principles of ICH Q12 and Q2(R2)/Q14, and the status of guideline adoption across various companies and health authorities.
Roger Nosal Awarded ISPE Distinguished Achievement Award
Roger Nosal is the 2024 recipient of the ISPE Richard B. Purdy Distinguished Achievement Award. This award honors an ISPE member who has made significant, long–term contributions to the Society.
ISPE input to Draft Guidance, Regulations, and Consultation Documents
ISPE recently submitted comments on:
- FDA draft Guidance: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
- See all past comments
ISPE Regulatory Resources:
- ISPE Regulatory Initiatives
- Regulatory Updates
- Subscribe to the Regulatory Digest
This quarterly newsletter is dedicated to news about ISPE’s regulatory and quality activities.
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.