As innovation abounds in science and medicine, there exist endless new 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! The requirements and governing bodies for each part of the product are vastly different making it nearly impossible to reconcile all the rules. Factor in new laws and regulations, such as the 21st Century Cures Act (CCA), and the complexity of compliance increases further.
This short course provides an overview and comparison of drug, device, and biologics regulation in the United States, and the complex place where combination products fit within these regulations. It follows the product lifecycle, from development through post-market activities, including classification, pre-clinical and clinical requirements, applicability of Good Manufacturing Practices (GMPs) and quality systems, and labeling requirements. It will also introduce the latest statutes, regulations and guidances that impact combination products and discuss how these changes are affecting the existing market.
The short course will be interactive. It has been designed to integrate substantive regulatory knowledge and the real-world problems of combination products. You will dive into case studies of unique combination products and get a sense of the gray areas that make the current regulatory scheme so difficult to navigate. It’s an opportunity to ask questions, share your challenges, gain the insights of your instructors, and learn from the experiences of your colleagues. If you are new to the field of combination products, this course will give you the foundation to move forward in your career.
An additional registration fee is required for all preconference short courses.
Who should attend?
This short course is designed for regulatory, quality, and clinical professionals and project managers who are new to combination products.
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;
- Discuss how recent regulatory developments, including the 21st Century Cures Act enacted in 2016 and resulting FDA guidances, affect combination products.