We all need to find faster and more efficient routes in the development of new drugs and the support of approved products. This forum provides a unique peer-to-peer learning experience. The practical approaches for the selected topics are seldom the subject of publications, and often deal with material and experiences that cannot be published. This years topics are:
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Topic One: Established Conditions and Module 2
This session will discuss the Established Conditions (ECs) as a key element of the Draft ICH Q12 guidance. Discussions will focus on identification of ECs and how an applicant may effectively communicate the associated foundational development work through a Comprehensive Quality Overall Summary (cQOS).
Topic Two: Comparability: Science and Guidance on Protocols
This session explores the regulatory expectations and industry approaches for establishing comparability after changes in manufacturing or packaging sites, process, equipment, raw materials, or packaging throughout the product lifecycle.
Topic Three: Post-Approval Change Management
Change Happens: Join real life discussion on life cycle management of approved drugs, biologics and combination products. Manage this change within the United States and globally. Practical discussion on how to navigate the regulatory pathways to keep “change” in compliance: Data packages needed, comparability protocols, ICH Q1E; established conditions.
Topic Four: Control Strategies for Early-Stage Clinical Supplies
This session will focus on impurity control strategies during early stage pharmaceutical development for small molecules. It will include two subtopics: non-mutagenic organic impurities (reference ICH Q3A/B guidance) and mutagenic organic impurities (reference: ICH M7 guidance).
Using a parallel breakout session format, all four topics are discussed in a small group format to ensure all participants have space to ask and answer questions, share experiences, and learn as peers.