Recent Developments in ICH Harmonization - Webinar Recording/Transcript
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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:
- Why the ICH Q12 guideline is a game-changer for pharmaceutical regulatory and quality professionals
- What the phrase “Established Conditions” really means
- How to prepare successful Post-Approval Change Management Protocols to expedite manufacturing process improvements
- How to use product lifecycle management documents in your submissions and future change management
- The most problematic components of your submission of product lifecycle management plans
- The nuances in global harmonization of the BCS classification system for requesting biowaivers under ICH M9
- What to expect for the global harmonization of bioanalytical method validation under ICH M10
Get ready to streamline your global drug development.