This fall, Regis Custom Pharma will host a series of breakfast seminars on “Speeding Drug Development through State-of-the-Art Impurity Control Strategies.” Guest speaker Steven Baertschi, Ph.D. will deliver the technical talks, which are open to the public, in Morton Grove (10/17), South San Francisco (10/31), and San Diego (11/1).
Registration is required as seating is limited. Arrive at 8:00am for coffee and networking; the seminars will each begin at 8:30am and will last one hour. Those interested should register online.
Baertschi will present risk-based, chemistry-driven approaches to speeding the development of organic impurity control strategies throughout clinical development. He will discuss the ICH M7 guidline for mutagenic impurities and the lack of regulatory guidance regarding impurity controls at early stages of clinical development prior to Phase 3. Relevant examples and references will be provided.
Dr. Baertschi specializes in stability, impurity, analytical, solid-state, and formulation issues. He earned his Ph.D. in Organic Chemistry in 1989 from Vanderbilt University and then spent 29 years at Lilly. He has published multiple works, including a book on Pharmaceutical Stress Testing: Predicting Drug Degradation, and chaired many conferences on stress testing, stability, photostability, and impurities.
More information, including the abstract and how to register, are available on the “Speeding Drug Development through State-of-the-Art Impurity Control Strategies” websites:
Regis Technologies hosts technical seminars at its Morton Grove, IL CGMP facility and around the country throughout the year. Subscribe to receive invitations to these events and watch past events by visiting our Video Library.