Simplifying Global Compliance
Biologic-Device Combination Products: One Size Does Not Fit All
Held June 26, 2008
In this 90-minute audio CD/transcript, 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.
Order now for 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.
Order 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.
This audio CD/transcript is a must-attend for employees of biotech and device companies, including:
- Compliance officers
- Consultants/service providers
- Executive management
- General/corporate counsel
- Personnel new to the industry
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- R&D staff
- Regulatory/legislative affairs professionals
- Strategic planning and business development staff
toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
Dr. Joyce Frey-Vasconcells
, executive director of PharmaNet Consulting, served more than 12 years at the FDA, most recently as deputy director of the Office of Cellular, Tissue, and Gene Therapies (OCTGT) within CBER. While at the FDA, Joyce was instrumental in developing many of CBER's policies regarding biologic-device combination products. Since joining PharmaNet Consulting, she has continued working with industry and organizations whose mission is to foster product development in the areas of cell therapy, tissues, gene therapy and tissue engineered products. She is considered one of the foremost regulatory experts regarding tissues, cell therapies, combination products, gene therapies and tumor vaccines, and brings extensive regulatory expertise and experience for this unique group of products.
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