Regulatory Strategy Forum for Medical Devices

In this highly interactive, hands-on Regulatory Strategy Forum, proven experts from the medical device industry will lead you in engaging discussions and interactive case studies analyses that will give you the insight and tools you need to develop a successful global regulatory strategy.

In addition to gaining an appreciation for global differences in submission formats and filing strategies and an understanding of the critical importance of monitoring and revising your strategy, you will examine such vital subjects as:

• Regulatory intelligence
• Business partnerships
• Essential elements of a Global Regulatory Strategy Document (GRSD) and Design Dossier

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. Successful global regulatory strategies maximize commercial opportunities for healthcare product manufacturers while minimizing company risk. By engaging in in-depth analysis and workgroup collaboration, you will gain a thorough understanding of ways to enhance your strategy and further your product’s success.

Learning Objectives

• Define the role of regulatory strategy in product development and lifecycle management including who should be involved in setting the strategy as well as mechanisms for researching requirements and ensuring your documentation is up-to-date
• Outline the major components of a Global Regulatory Strategy Document (GRSD) and the content for each section
• Identify specific regulatory issues related to the development of your medical device or its target markets and how to mitigate regulatory risk through effective management of the strategy plan

Target Audience

Mid-level regulatory professionals from industry and consulting firms planning international submissions.