InstructorRoyed Training
TypeOnline Course
Price$180 USD / 7500 INR
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Course Code: RYD-025

Course Title: Competency Development Program in Regulatory Affairs Strategic Planning

Course objective: Regulatory strategic orientation plays vital role in pharmaceutical business and indeed innovative and agressive regulatory strategy helps organization to differentiate from other.

Changes in the Pharmaceutical sales model have forced Global Pharmaceutical Sales Leaders to invest in new selling strategies in recent years. However, many of these New Commercial Models (NCMs) are not proven to produce success. Handling uncertainty is the key in making successful regulatory affairs strategy. A in-depth understanding in regulatory strategy is key skill which will help regulatory manager’s to take successful, tactical strategies to make molecules portfolio active and growing.

This course is designed to provide comprehensive understanding on regulatory strategic management process which is a key skill for pharma middle level managers.

Duration: 7 Days

Learning Objectives:

  • Quick understanding on Drug Discovery to commercialization
  • Concept of Pharmaceutical Strategic Planning
  • New Innovator’s Strategic Management – LOE strategies for Innovator’s Brand
  • Evergreening of pharmaceuticals
  • Licensing of pharmaceuticals – In and Out Licensing
  • Compulsory Licensing
  • Generic Drug Strategic Management – Para IV Filing / Handling of Para IV notices
  • ANDA development strategies – Suitability petition vs. 505b2 pathway
  • Pay for Delay
  • REMS strategic planning

Who will Benefit:

  • Person working in the pharmaceutical manufacturing department / F&D personnel
  • Regulatory Affairs personnel
  • Research and Development personnel
  • Quality Assurance & Control personnel
  • Development and Preparation of Submission Materials
  • Project management professionals who must have detailed insight on the regulatory strategic management process.

Certification: Certificate will be provided at the end of the course after completion of the final examination.