home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
  HUM-MOLGEN -> Events -> Courses and Workshops  

Safety Assessment for Medical Devices and Combination Products

  February 03, 2015  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
10-12 June 2015

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.

Course 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.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Dr. Shayne C. Gad; Principal of Gad Consulting Services

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, is the principal of Gad Consulting Services, a twenty-three year old consulting firm with six employees and more than 450 clients in the US and overseas. Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson, as a manager of the toxicology lab at Allied Signal, and at Chemical Hygiene Fellowship at Carnegie Mellon Institute.

Dr. Gad has published 47 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and medical device development and safety assessment. He has previously served as a Counselor and President for ACT, as President of three SOT specialty sections and the Roundtable of Toxicology Consultants, as a reviewer for NIH, and editor of two journals. He has also conducted the triennial salary survey for toxicologists. He has more than 37 years of broad based experience in these fields and has successfully filed more than 106 INDs.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.