VP, Technical Services and Scientific Affairs
April 03, 2019
The keynote speakers discussed:
- Combination Product Development & Regulatory Best Practices: Drug/Biologic PMOA Perspective. Suzette Roan, JD, Sr. Director, Global Regulatory Affairs, Devices, Sanofi
- Combination Products: Risk Management and Control Strategies. Susan Neadle, Leader, Value Chain Quality, Johnson & Johnson
- Combination Products Hot Topics: Post-Approval Device Changes and the New EU MDR 117 Requirements. Doug Mead, Sr. Director, Regulatory Affairs, Johnson & Johnson
Key takeaways included:
- The global regulatory landscape is dynamic and changing frequently; it is normal to feel “not up to date” on all aspects of combination products.
- For both drug and device development, a structured and harmonized development process, using a risk-based approach and a sound quality system, is needed. Even though the “language” or terms may be different in the two areas, consistency in framework helps bring them together. This approach is needed in combination product development.
- It is important to start always with the end in mind. This means understanding the drug target product profile, and the device user needs, from the beginning of development.
- Focus must be on both the safe and effective use of a combination product.
- Essential is risk management, which is the process of identifying hazards, evaluating associated risks, mitigating/controlling risks, and monitoring the effectiveness of controls.
- Processes for change control should include product risk analysis and an understanding of regulatory impact.
- EU MDR Article 117, which replaces the MDD, is effective on 26 May 2020
The workshop also included demonstrations of West’s capabilities in container closure integrity (CCI) testing, performance testing, and flexible filling of polymer cartridge systems used in combination products.