Regulatory Strategy Forum for Biologic Products

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)