Description: Biologics are more complex than small molecules, so they have different regulations. This session will discuss in-depth the practical challenges and issues that come up during biological products, as well as how to make effective global strategies for the worldwide development of biological molecules, with a particular focus on monoclonal antibodies. The session will be more focused on real-life examples and case studies that will navigate the attendees on how to make effective global regulatory CMC strategies that take into account the different ways that different regulatory agencies do things, with a particular focus on the US FDA, EMA, Health Canada, and TGA. The session will discuss the end-to-end development approach and strategies, starting with phase 1 clinical and going all the way up to the market approval of biologics and beyond (post-approval). The session will help professionals to use these strategies throughout the life cycle of the biological molecule to get approval faster.
Learning Objectives:
Apply/implement effective regulatory practices throughout biologicals' lifecycle (from phase 1 till post-approval) to comply with regulations to gain faster access to biologicals for the patients in need.
Practice and learn how to use regulatory interactions/meetings, publicly available information, and databases available from Regulatory authorities during the development of biologicals.
Analyze the gaps which can lead to unnecessary delays in drug approval. The session will provide deep insights into these gaps and what can be done proactively to address these issues.
