Best Practices for Global Regulatory Intelligence: Dos and Don'ts
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of MissouriColumbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Tra spare y Pu li Meeti g. Prior to fou di g his ow o sulti g fir (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: This webinar is intended to help you get familiarized with the best practices for global regulatory intelligence including dos and don'ts. This webinar is further intended to increase our awareness for the importance of implementing a holistic global regulatory intelligence program suitable for your medical product types. It is believed that actionable and practical regulatory intelligence can help an organization save a significant amount of resources (time, efforts and financial). This webinar will address the best practices for you to take action, significantly benefiting your organization in many ways. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation: The key objectives of the presentation are to give better insight on: Applicable Laws and Regulations Regulatory Intelligence for Drugs, Biologics, Biosimilars, and Medical Devices including In Vitro Diagnostic Medical Devices (IVDs) R&D, Patenting (IP) and Applicable Regulatory Pathways Intellectual Property (IP) Issues Alignment between Regulatory Plan/Strategy, Reimbursement, and IP New Requirements to Integrate: Risk Management Plan (RMP)/Pharmacovigilance (PV) FDA Unique Device Identification/Identifier (UDI) Detailed Contents Common Mistakes Leading to Serious Consequences (Patient Safety and Business Operations) Practical, Actionable, and Sustainable Solutions (PASS) www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend: Attend this webinar to adequately develop and implement a holistic global regulatory intelligence program.
Who can Benefit:
Regulatory Affairs Management: CEOs, VPs R&D and Product Development Legal Counsel and Compliance Officers Marketing Clinical Affairs Consultants Contractors/Subcontractors Other Interested Parties
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works?
Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve Get certification of attendance.
Recorded Session - How it works?
A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf format will be mailed to you Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com