Description: The landscape of biologics is more complex than that of small molecules and is constantly evolving. With biological regulations differing worldwide, developing a global strategy can be challenging. In this workshop, we will discuss the Regulatory framework for biologicals in the US, EU, Canada, and China.
The workshop will cover in-depth, real-life case studies from the end-to-end life cycle of biologics, ranging from phase 1 clinical trials to post-approval, and help participants understand the regulatory CMC submission pathways, requirements, challenges, gaps, pragmatic solutions, and strategies for health authority interaction, with a focus on monoclonal antibodies and recombinant proteins.
Furthermore, as biological products are often used with devices, there are special regulatory CMC considerations that need to be followed for developing these biologics-device combinations. We will also cover these aspects in brief to provide a holistic view to avoid unnecessary delays during the approval process.
On top of it, we will also discuss, in short, how emergent digital paradigms such as the FDA's KASA and PQ/CMC initiatives will redefine regulatory CMC submissions, preparing participants to take advantage of digital advancements.
The Preconference workshops are not included in the Main Conference registration. You can register for the workshop via the website: Visit the website!
Learning Objectives:
Learn how to implement effective regulatory practices (for the US, EU, Canada, and China) throughout the lifecycle of biologicals, from phase 1 to post-approval, to ensure CMC compliance with regulations. Analyze the gaps that can lead to unnecessary delays in drug approval.
This session will offer valuable insights into these gaps and proactive measures that can be taken to address these challenges.
Practice and learn how to use the most resources e.g., interactions/meetings, publicly available information, and databases available from Regulatory authorities during the development of biologicals.
The session will provide insights into these resources and how we can use them to develop regulatory CMC strategies during the development process.
To understand the regulatory paradigm changes for the biological vs. biological-device combination products. Also, to gain future insights on the impact of digitalization on CMC strategies and submissions, for e.g. FDA's KASA and PQ/CMC initiatives.
The session will provide brief insights on the biologics device combination product aspects and the digital initiatives from health authorities.
