This Medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges. Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!
Despite the controversy, the best known example of a combination product is the drug-eluting stent. However, the drug-eluting stent is also an extremely primitive example of a combination product. The quintessential example of a combination product is tissue engineering. Why? Because we have cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices).
It’s hard to imagine more of a combination product than that - or can we? During this two-part interactive workshop, participants will be exposed to examples of combination products on the market, under development and on the drawing board.
Despite the controversy, the best known example of a combination product is the drug-eluting stent. However, the drug-eluting stent is also an extremely primitive example of a combination product. The quintessential example of a combination product is tissue engineering. Why? Because we have cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices).
It’s hard to imagine more of a combination product than that - or can we? During this two-part interactive workshop, participants will be exposed to examples of combination products on the market, under development and on the drawing board.
- What Attendees will Learn
- What is a combination product? How are they regulated now and what will likely change in the future?
- How do the cultural and philosophical differences between CDER, CBER and CDRH impact the FDA approval process?
- What value does the FDA Office of Combination Products (OCP) really provide? What does the OCP do that’s not on their web page?
- How can we use the request for designation (RFD) and primary mode of action (PMOA) concepts to our advantage in bringing products to market more efficiently?
- What are the challenges of convergence? How can drug, biotech and medical device companies communicate when they don’t speak the same language?
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Biotech, Pharmaceutical, and BioPharma. The employees who will benefit include:- Research & Development
- Manufacturing Profesional
- Regulatory Professional
- QA managers and personnel
- Legal
- Marketing
Course Provider
Michael Drues,
