As technology advances, so do opportunities for combining different technologies to solve some of the world’s most pressing medical issues. The lines between engineering, chemistry, and advanced biologic processes are becoming blurred – the age of combination products is here.
There are significant differences between the development processes for drugs, devices, and biologics. Theoretically, if the product complies with the regulations specific for each component of the combination product, then your company should be covered, right? Not quite! Because the constituent parts of a combination product are regulated using different regulatory standards, this is nearly impossible. Factor in new laws and regulations such as the 21st Century Cures Act (CCA) and the European Medical Device Regulation (MDR), and the complexity of compliance increases further.
This short course provides an overview and comparison of drug, device, and biologics regulation in the US and EU, and the intersect that defines how combination products fit within these regulations. It covers pre-market activities including clinical requirements, applicability of Good Manufacturing Practices (GMPs), post-market activities, and labeling requirements. It will also introduce the 21st CCA and the European MDR, and how combination products are impacted by them. The course will be interactive. Case studies will be presented, but you are also encouraged ask questions and share your own examples of challenges and successes.
If you are a regulatory professional or project manager new to the field of combination products, or are simply switching disciplines, this course will provide you with the foundation to move forward in your If you are a regulatory professional or project manager new to the field of combination products, or are simply switching disciplines, this course will provide you with the foundation to move forward in your career.
An additional registration fee is required for all preconference short courses.
At the conclusion of this course, participants should be able to:
- Discuss how combination products fit into the development processes for drugs/biologics and medical devices
- Identify the unique challenges of premarket and post-market requirements for combination products in the US and EU
- Discuss how the 21st Century Cures Act and the EU Medical Device Regulation affects combination products