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Preparing for the International Harmonization of Medical Devices

  December 21, 2009  
The Center for Professional Advancement, 90 Minute Accredited Online Training
February 9, 2010 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend
This online training is valuable to professionals in the Medical Device industry. It will be especially worthwhile to personnel involved in the regulations of medical device manufacturing, design and marketing. Executives, managers and consultants within medical device organizations whose focus is on international registration and regulations will find this training extremely beneficial.

Realizing the ever shrinking global medical device market, device companies must stay up to date with international harmonization efforts. This 90-minute accredited training course will focus on the current state of affairs within the medical device industry relevant to obtaining international harmonization. Discussions will include the global and national players in this arena, their requirements and restrictions and the current motivations and contentions within these organizations. Roadblocks to this initiative and the anticipated steps to achieving future harmonization will also be addressed.

Module 1: The Harmonization World:
  • Global Players: WHO, OECD, ISO
  • National Players: US FDA, EMEA, Japan Ministry, 
    Australia FED, Canadian Ministry, Swiss Ministry, 
    Israel Ministry, China FDA, India FDA, 
    South Korea FDA
    – Motivations and contentions
    – Trade
    – Market access
    – Consistency of enforcement
    – The access/safety balance

Module 2: Medical Device Issues:
  • Predicate Devices
    – The 1976 divide
    – Function vs design
  • Clinical Testing: the PMA, need for short term and long 
    term tests
  • CE Mark and equivalent, registration requirements

Module 3: Two Steps Forward, One Step Back: The Future:
  • 505(b)2 Equivalent
    – Accepting outside tests
  • Derivative devices
    – Patent extension, modification and combination
  • New directions
    – Redefining risk, change, and test

Question and Answer Session

Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Sandy Weinberg, Associate Professor of Health Care Management (Regulation) at Clayton State University, part of the Georgia State University System; retired regulatory professional from the drug, device and vaccine industries.

Dr. Weinberg is teaching and researching Regulation and Biodefense. He is a consultant to the FDA regulated industries and is a former consultant to the FDA and other international regulatory agencies including Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health.

He has been a leader in the field of system validation for more than twenty years, and a practitioner in regulatory submissions, auditing, international liaison and biodefense vaccine development. Dr. Weinberg is the author of numerous books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, Good Laboratory Practice Regulations, and The Handbook of Drug Regulatory Submissions. His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.

Dr. Weinberg is a member of the Board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands. Recently retired, Dr. Weinberg was Senior Director for Biodefense at GE Healthcare and Vice President of Tikvah Therapeutics; as well as an investor in and Board member of several international biomedical companies.

Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas. Recent projects include the auditing and certification of a chromatography control system; a business development and fund raising project for a biodefense vaccine company; an Orphan Drug submission; and the validation of a Laboratory Information Management System. Much of Dr. Weinberg’s practice is centered in the US, Western Europe and Israel.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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