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CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
3-5 October 2012
Who Should Attend
This course is intended for professionals who have responsibilities for the safety and marketing approval of medical devices and drug/device combination products. It will be especially valuable to:
• Scientists
• Engineers
• Biologists
• QA/QC
• Manufacturing personnel
• Regulatory affairs
These individuals may come from industrial, government, academic and/or contract testing facilities. The course should be especially useful for those newly assigned to product safety responsibilities although it also provides an opportunity for more experienced personnel to update their knowledge. Description
The aim of this course is to review the principles of testing materials for biocompatibility. The full range of test methods will be discussed including chemical analysis, cell culture and other in vitro methods, acute animal studies including USP methods, thromboresistance, sensitization, long-term implant and other special studies. The nature of polymers and the sources of incompatibility will be discussed along with specific examples. Methods of testing will be related to the end use of a product. Examples of recommended testing programs will be presented, as well as the impact of FDA’s Good Laboratory Practice regulations and ISO requirements on preclinical testing of materials and medical devices.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Dr. Shayne C. Gad; Principle, Gad Consulting Services
Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, a nineteen year old consulting firm with six employees and more than 500 clients (including 50 device companies in the US and 30 overseas).
Dr. Gad served in director-level and above positions at Searle, Synergen and Becton Dickinson. He has authored or edited more than 44 published books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and safety assessment. He has more than 34 years of broad-based experience in toxicology, drug and device development, statistics and risk assessment.
Dr. Gad has specific expertise in biocompatability and risk assessment, neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award, he has direct involvement in the preparation of INDs (93 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. Dr. Gad has consulted for FDA, EPA, and NIH, and has trained reviewers and has been an expert witness for the FDA.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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