Global Medical Device Regulations: US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan: One and a Half-day In-person Seminar

Location: Boston, MA
Dates: JAN 29th – 30th, 2015

Speaker: David Lim, Medical Device

Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, www.RegulatoryDoctor.com, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides Practical, Actionable and Sustainable/strategic Solutions in an Integrated, Thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters. Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). In addition, Dr. Lim has completed two years in law school. Dr. Lim is an auditor, regulatory coach, mentor, consultant and instructor for global matters pertaining to regulatory affairs, quality, clinical affairs and compliance.

Course Description:

Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.

Reasons to attend:

In this One and a Half-day In-person Seminar the trainer will walk you through to get familiar with the medical device regulations in the following twelve (12) countries.

1. US
2. EU
3. Canada
4. Argentina
5. Australia
6. Brazil
7. India
8. Japan
9. Mexico
10. Russia
11. South Korea
12. Taiwan

This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.

The following areas will be discussed during the workshop:

• Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan
• In EU, the following four Directives will be discussed.
  • DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
  • DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
  • DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
  • DIRECTIVE 2007/47/EC Amending MDD and AIMDD
• ISO 13485
• ISO 14155
• ISO 14971
• GHTF documents
• MEDDEV guidance documents
  • Clinical investigation
  • Adverse event reporting

Target Audience:

This seminar will be valuable for anyone in the European Commission (EC) and FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those involved in research and product development, handling data and documents for regulatory submission for CE-marking purposes, conducting/monitoring/coordinating clinical investigation, and/or performing risk management and post-market vigilance/surveillance. This workshop is a must for those who are directly or indirectly involved in drafting and handling applications for CE marking purposes.

The following personnel will benefit from the course:

• Regulatory affairs (associates, specialists, managers, and directors)
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
• Research and development (associates, scientists, managers, directors and VPs)
• Product and development (associates, scientists, managers, directors and VPs)
• Contract research organization (associates, scientists, managers, directors and VPs)
• Site managers, and consultants
• Senior and executive management (VPs, SVPs, Presidents and CEOs)
• Contractors and subcontractors
• Anyone interested!

AGENDA:

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Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com