10–11 December 2012
RAPS Training Center
Rockville, MD
Regulatory professionals who can help create a sound global regulatory strategy, essential to the development and commercial success of biologic products, are critical to the success of their companies. By engaging in in-depth analysis and workgroup collaboration in this highly interactive Regulatory Strategy Forum, you will gain insight and experience in proven methods to enhance your strategy development ability and further your product’s success.
Leading practitioners in biologics regulatory affairs will provide expertise and direction for participants, engaging them in discussions and interactive case study analysis. This program will give you the knowledge and tools you need to develop a successful global regulatory strategy.
Examine global differences in submission requirements filing strategies, as well as the critical importance of continuously monitoring and revising your strategy. Major topics to be discussed include:
- Integration of regulatory strategy with business and development objectives
- Regulatory requirements for nonclinical and clinical development
- Chemistry, Manufacturing and Controls (CMC) regulatory strategy beyond marketing approval
- Regulatory pathways for biologics and biosimilar products
- Essential elements of a global Regulatory Strategy Document (RSD) and Target Product Profile (TPP)
Learning Objectives
- Describe the role of regulatory strategy in product development and lifecycle management
- Outline the major components of a global RSD and the content that should be included in each section
- Identify specific regulatory issues related to biologic product development and strategies for their effective management
Target Audience
This program will benefit mid-level regulatory professionals from industry and consulting firms, who work with, or anticipate working with, biologic product development.