Developing and Implementing a Global Regulatory Plan and Strategy

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued. Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy. At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

Areas Covered in the Session :

  • Applicable Laws and Regulations in EU, Canada, and US
  • Questions and Issues to Identify and Address
  • Interfacing: Roles and Benefits
  • Alignments between Functional Departments/Groups
  • What Is Critical When Implementing Global Regulatory Intelligence Program
  • Mapping Regulatory Requirements and Pathways
  • When/How to Prevent Costly Mistakes
  • Best Approaches: What to Integrate
  • Practical, Actionable, and Strategic Solutions (PASS)
  • Speaker’s Experience and Actual Cases
Who Should Attend:

  • Regulatory Affairs Departments
  • Research and Development Departments
  • Quality Departments
  • Clinical Affairs Professionals
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Marketing Departments
  • Senior Management
  • Contractors and Subcontractors
  • Consultants

FDB2518

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance