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Home » Store » Drug Products » Recent Developments in ICH Harmonization - Webinar Recording/Transcript

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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.

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