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.

  • Biopharmaceutical manufacturers
  • New Drug and Generic Drug manufacturers
  • Active Pharmaceutical Ingredient manufacturers
  • Quality professionals
  • Regulatory professionals

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.