Implementing Best Practices for Global Regulatory Intelligence Programs: Dos and Don

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Length
60 minutes
Product Description

What Firms Should Consider and Address When Implementing a Holistic Global Regulatory Intelligence Program

Establishing a practical, actionable and sustainable regulatory intelligence program can help an organization save a significant amount of resources (time, efforts and financial). Thus, it is imperative industry become aware of and get familiar with the best practices for developing and implementing a global regulatory intelligence program.

This conference by our expert speaker, David Lim, is intended to discuss the best practices for developing and implementing a global regulatory intelligence programs, including dos and don’ts. It will also discuss how to implement a holistic global regulatory intelligence program suitable for your medical product types.

Session Highlights:

  • Applicable Laws and Regulations
  • Definitions
  • Guidance, Rules, and Standards
  • What to Consider for Regulatory Intelligence of Drugs, Biologics, Biosimilars, and Medical Devices including In Vitro Diagnostic Medical Devices (IVDs)
  • Identify and address questions and issues
  • Totality and Flexible Approaches
  • Interfacing:  Roles and Benefits
  • Reimbursement and Intellectual Property (IP) Issues
  • Alignment between Regulatory Plan/Strategy, Reimbursement, and IP
  • New Requirements to Integrate
  • Detailed Contents
  • Commonly made Mistakes Leading to Serious Consequences
  • Practical, Actionable, and Sustainable Solutions (PASS)
  • Speaker’s PASS-IT Recommendations: Dos and Don’ts

Who should attend?

  • Regulatory Affairs
  • Management: CEOs, VPs
  • R&D and Product Development
  • Legal Counsel and Compliance Officers
  • Marketing
  • Clinical Affairs
  • Consultants
  • Contractors/Subcontractors

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
More Events By The Speaker

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