Industry and regulatory experts addressed best practices and obtained fresh technical information in order to bring clarity and direction around the risks and challenges of packaging and delivery systems – with an ultimate focus on combination products. Key points addressed included particulates, biocompatibility, leachables/extractables, biologic stability, and container closure integrity. The meeting opened with a plenary session, The Future of Drug Delivery by Didier Pertuy, Vice President and Global Head of Drug Device Integrated Development and Device Strategy, Sanofi. Other sessions were:
- Strategies for Safety Evaluation
- Leachables and Extractables for Combination Products that Include Both Drugs and Devices
- Holistic Safety and Quality Assessment
- Particle Challenges Associated with Delivery Systems and Devices
- Compatibility of Delivery Systems with Biologics
- Quality Considerations for Combination Products and Device
A summary can be found here.