Using Science to Navigate the Global Regulatory Maze

On- Demand Webinar

This Solution Provider Webinar is brought to you by DIA in cooperation with ProPharma Group



In This Webinar...

Achieving successful outcomes in a complex regulatory landscape can be challenging, especially when caught in the maze of regulatory agency requirements from varying countries. For many pharmaceutical, biotech and medical device companies with products at varying stages of development, reaching regulatory milestones is a critical path for success. Scientific interpretation and proper presentation of data generated by Sponsors is THE key to succeeding with the FDA and EMA.

Learning Objectives:

  • Useful tips for interpreting the appropriate scientific data
  • Effective techniques to positively present the scientific advances for regulatory requirements
  • How best to navigate through the regulatory hurdles and milestones with the FDA and EMA using scientific data

Featured Topics:

  • Constructive scientific data interpretation for achieving successful outcomes
  • Effective presentation templates and styles to fit regulatory agencies' applications
  • Helpful preparations for reaching regulatory milestones

Presenters:


  Matthew Weinberg, MBA, Chief Executive Officer, The Weinberg Group; Vice President, Global Regulatory Affairs, ProPharma Group

  Dr. Colin Wheeler, MBChB, FFPM, DPM, Chief Executive Officer, Southwood Research; Vice President, European Regulatory Affairs, ProPharma Group