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
Areas Covered in the Seminar:
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:
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.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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