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Recent Developments in ICH Harmonization: Lifecycle Management, Biowaivers & Bioanalytical Method Validation
ICH is developing guidelines to improve implementation of post-approval chemistry, manufacturing, and controls (CMC) changes, harmonization of the biopharmaceutics classification system (BCS)-based biowaivers, and bioanalytical method validation.
The ICH Q12 on Lifecycle Management and ICH M9 on Biopharmaceutics Classification System-Based Biowaivers were recently released for public comment. The ICH M10 Bioanalytical Method Validation is currently at Step 1 in the development process.
These guidances promise to streamline global drug development as well as improve pharmaceutical manufacturing and quality assurance.
Keith Webber of Lachman Consultant Services, Inc. — will discuss the current status and expectations of the ICH guidelines. Over the course of 90-minutes you’ll learn:
Get ready to streamline your global drug development.
Keith Webber, Ph.D. is the Vice President of Biotechnology at Lachman Consultant Services, Inc. Before joining Lachman, he served as Sr. Director of Rx Regulatory Affairs at the Perrigo Company. Prior to joining industry, he served at the US FDA in both the Center for Drug Evaluation and Research and CBER. During his 18 years with the Agency, his roles included Director the Office of Pharmaceutical Science, Director of the Office of Biotechnology Products, and Director of the Office of Generic Drugs. He also represented the generic drug industry on the ICH Q12 Expert Working Group.
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