3-hr Virtual Seminar- Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada

Why Should You Attend:

To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline regulatory compliance processes, in particular, the Adverse Event (AE) Reporting during clinical studies and post-marketing. Thus, to establish and maintain a medical device AE reporting and surveillance/vigilance system, it is critical to have a “current, accurate, and complete” (CAC) information and knowledge of compliance requirements in a systematic, integrative (SI) manner on a global basis.

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing. This seminar is a “How To Guide” for empowering those involved and is intended to streamline the processes of adverse event reporting and surveillance/vigilance system in a systematic, integrative
(SI) manner.

Areas Covered in the Seminar:

• Current, accurate, and complete (CAC) information on adverse event reporting.
• Systematic and integrative (SI) review of regulations and law governing an adverse event reporting in the US, EU and Canada.
• 21 CFR Part 820 and ISO 13485
• GHTF guidance(s).
• EU Directives and Guidelines.
• EU Risk Management.
• US FDA Reporting.
• ISO 14155.
• ISO 14971.
• Global guidance for adverse event reporting for medical devices.

Who Will Benefit:

This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in the processes of adverse event reporting, complaint handling and regulatory compliance. By understanding the adverse event reporting requirements in a systematic and integrative manner, the process owners can better establish and maintain the compliant processes, improving patient safety and achieving global regulatory compliance.

The following employees who will benefit include:

• Complaint handling personnel
• Regulatory affairs (associates, specialists, managers, and directors)
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
• 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)
• Marketing (associates, specialists, managers, directors and VPs)
• Site managers, and consultants
• Contract manufacturing organization (associates, scientists,managers, directors and VPs)
• Contract research organization (associates, scientists, managers,directors and VPs)
• Senior and executive management (VPs, SVPs, Presidents and CEOs).
• Contractors and subcontractors

Instructor Profile:

Dr. David Lim, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia in 1993. Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo and US FDA (Center for Devices and Radiological Health (CDRH) at US Food and Drug Administration). In 2009, Dr. Lim served as a panel member during the Transparency Public Meeting organized by the FDA. Currently, Dr. Lim is Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc., in New York. Prior to Aquavit Pharmaceuticals, Dr.
Lim served as Director of Regulatory Affairs at EraGen Biosciences, Inc., A Luminex Company in Madison, WI. 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). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs.

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