Safety Assessment for Medical Devices and Combination Products

May 27, 2016

CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
14-16 November 2016

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:

Shayne C. Gad, PhD, DABT; Principal, Gad Consulting Services (GCS)

Dr. Shayne C. Gad, B.S.(Whittier College, Chemistry and Biology, 1971) and after active duty service in the U.S. Navy, Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, Principal of Gad Consulting Services, a twenty-three year old consulting firm with eight employees and more than 500 clients in the pharmaceutical and medical device industries, including providing QSAR and impurity, leachables and extractables assessments and qualifications. 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 in 2008. Served on Council, Membership, Program, and Animals in Research committees for ACT, multiple committees in SOT, and currently on the regulatory opinions committee of the Society of Toxicologic Pathologists. Previously at CMIR Chemical Hygiene Fellowship, Allied Chemical, Searle, Becton Dickinson and Synergen. He has authored or edited 47 published books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and device development and safety assessment. He has more than 39 years of broad based experience in toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment and genotoxicology. Grant reviewer for EPA, CAAT, NIH, and Canadian Health. He has direct involvement in the preparation of INDs (109 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. Served as the COO of two pharmaceutical companies while a consultant. He initiated and has conducted the triennial toxicology salary survey as a service to the profession of toxicology for the last 39+ years.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

jmorbit@cfpa.com

home

genetic news

bioinformatics

biotechnology

literature

journals

ethics

positions

events

sitemap