MSc RA Module 1: Strategic Planning in Regulatory Affairs

Module 1 Strategic Planning in Regulatory Affairs
12-14 June 2012 at Arcotel Kaiserwasser, Vienna, Austria
Aim:
As a Regulatory Affairs Professional progresses in his/her career, aspects of project management and strategic planning become more important. Individuals need to develop the ability to anticipate problems, analyse complex situations, and offer the optimal strategy in order to achieve marketing approvals worldwide in a timely manner.

Learning outcomes
• Students will determine the global regulatory strategies and development programmes required to achieve marketing authorisation approval in Europe, North America, Japan, and beyond.
• Students will assess and discuss the commercial implications of regulatory approval and pricing negotiations.
• Students will analyse regulatory issues relating to in and out licensing of products.
• Students will define the interactions between the company and the Regulatory Agencies.

Outline of Module topics:
• Strategic planning in the pharmaceutical industry
• Regulatory strategies for successful pan-European registration
• Regulatory strategy for the USA
• Regulatory strategy for Japan
• Regulatory strategy for the emerging markets (Far East, Africa, Latin America)
• Micro small and medium enterprises
• Commercial licensing of products and regulatory considerations
• Introduction to trademarks and patents
• Regulatory strategies and company interactions with Regulatory Agencies
• Pharmaco-economics – Pricing and reimbursement
• Electronic Common Technical Document submissions
• Relationship between Regulatory Affairs and other pharmaceutical company functions