Most regulatory professionals focus their careers on the regulations of a single country or region such as the US or EU. In order for a global regulatory leader to be truly effective, it is critical to understand the key regulatory issues in all major markets and to apply this knowledge to a global regulatory strategy. Communication between health authorities is increasing, making it vitally important that regulatory leaders develop their strategies with a global view. In addition, current trends in the pharmaceutical industry indicate that more and more companies are expanding their global presence to benefit from the explosive growth being projected in the emerging markets. It is essential, therefore, that a global regulatory leader possess the knowledge and skills necessary to enable successful product registrations in multiple markets around the world.
This course will allow participants to understand key requirements for the development and execution of a global regulatory strategy by identifying the strategic and tactical aspects of pharmaceutical development in the US, EU and emerging markets. Course participants will have the opportunity to apply learning objectives in a hands-on workshop.
Course Level: Intermediate
What you will learn
- Survey of the Global Regulatory Landscape
- Unique Challenges in Emerging Markets
- Assembling and Working with Global Development Teams
- Constructing and Implementing Global Regulatory Strategies
Who should attend?
Pharmaceutical Professionals with an interest in global regulatory requirements in the areas of:
- Regulatory Affairs with basic knowledge of investigational and marketing applications
- Business Development
- Commercial or Marketing
- Clinical Development
- Regulatory CM&C
- Academic Research
At the conclusion of this course, participants should be able to:
- Explain the importance of the regulatory strategy in pharmaceutical development and commercialization
- Apply key requirements for development in a global market to product strategy
- Plan for the implementation of the Global Regulatory Strategy across multiple regions
- Identify development areas requiring special considerations across various regions