Biologic-Device Combination Products: One Size Does Not Fit All
$427.00
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In this 90-minute Encore presentation, regulator expert Joyce Frey-Vasconcells will share with attendees her more than 12 years of insider information on how to properly and cost-effectively develop biologic-device combination products.
Sign up your entire team to learn:
- What defines biologic-device combination products and how they are currently regulated
- Best practices for overcoming the five main developmental challenges
- Four steps to speed regulatory approval
- Three considerations for safe and effective product planning
- Six tips for managing the device considerations of a biologic-device combination product
- Insight on how to deal with partners throughout the product's lifecycle
- How to manage the interdependence of product development and regulatory concerns
- Developing the product with the least risk of failure in the preclinical and clinical stages
- How to achieve a timely and effective premarket review
- What FDA centers have jurisdiction over biologic-device combination products
The stakes are much higher for biologic-device combination products. Those that get it right the first time can expect a larger share of this rapidly growing market.
Register now to discover the five major tenets of biologic-device combination product development you must master:
- Product development challenges — many of the regulations don't always fit what you are trying to develop
- Preclinical design considerations — failure to talk to the FDA early can delay your clinical development or cause your data to be rejected
- Clinical trial design — make sure you have properly tested the components as well as the product as a whole
- One size does not fit all — flexibility in your product development cycle is crucial
- Request for designation — if jurisdiction is unclear, you can get it clarified.