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The New Frontier of FDA Combination Products
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| Description: | Combination products have traditionally been identified as drug: device combinations packaged together as the same product (e.g. a drug eluting stent or an antibiotic infused material in a product). Today, the definition of “combination” product may extend to many other types of products which are used together. The need to explore the interactions between drugs and devices from different manufacturers appears to be increasing and future medical device and pharmaceutical companies may have an increasing need to partner and collaborate in bench, pre-clinical and clinical testing to determine the extent of drug/device interactions. This session will explore the question: “Does FDA consider EVERY drug that needs to be delivered in a device a ‘combination product’?” This audio conference covers: · An overview of the requirements and guidelines for combination products · The interrelated roles of device design specifications and drug chemistry manufacturing and controls (CMC) when developing a drug and/or device designed to be used with the other.. · Developing proactive strategies to better position partnering medical device and pharmaceutical companies for discussions with the FDA for future drug: device (and biologic) combinations About the Speaker: Dr. Joy Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries. She has held key positions including President and CEO of Frestedt Incorporated, Vice President of Scientific and Clinical Affairs at BridgePoint Medical and Humanetics Corporation, as well as other positions with Johnson & Johnson, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical. Dr. Frestedt holds a B.A. in Biology from Knox College and a Ph.D. in Pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, the American Association of Pharmaceutical Scientists, the American Society of Clinical Research Professionals, and currently serves as chair of the Ethics Committee for the Regulatory Affairs Professionals Society. Who Should Attend? Regulatory Affairs Professionals Medical Device Industry Engineers Medical Researchers and Clinical Trialists Drug Manufacturing Chemical Engineers Pharmaceutical Research and Development Scientists Clinical Data Stewards Product Safety Managers Quality Assurance Managers Senior Management Marketing & Communications Managers |
| URL: | http://www.fdaseminars.com/index_files/Register.htm |
| Date: | Tuesday, April 6, 2010 |
| Time: | 12:00pm-1:00pm EDT |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Health* |
| Created by: | Public Access |
| Updated: | Wednesday, March 3, 2010 7:01am EST |
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| : | fda_experts@yahoo.com |
| : | 407-260-2933 |
| : | 407-260-2933 |
| Comments: | None |
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