FDAnews Announces — Recent Developments in ICH Harmonization: Lifecycle Management, Biowaivers & Bioanalytical Method Validation Webinar, Jan. 17, 2019

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M9, M10 and Q12 are working their way through ICH’s five-step process. How will the guidances impact global drug development?

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WCG Market Intelligence & Insights

Recent Developments in ICH Harmonization
Lifecycle Management, Biowaivers & Bioanalytical Method Validation
**An FDAnews Webinar**
Tuesday, Jan. 17, 2019, 1:30 p.m. - 3:00 p.m. ET
http://www.fdanews.com/ichharmonization

ICH Q12… ICH M9… ICH M10… promise to streamline global drug development and continual improvement of pharmaceutical manufacturing and quality assurance.

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.

What does this mean?

Keith Webber, of Lachman Consultant Services, Inc., will discuss the current status and expectations of the ICH guidelines. Over the course of 90-minutes attendees will learn:

  • hy 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 submissions and future change management
  • The most problematic components of the 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 global drug development.

Meet The Presenter:
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.

Who Will Benefit:

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

Webinar Details:
Recent Developments in ICH Harmonization
Lifecycle Management, Biowaivers & Bioanalytical Method Validation
**An FDAnews Webinar**
Tuesday, Jan. 17, 2019, 1:30 p.m. - 3:00 p.m. ET
http://www.fdanews.com/ichharmonization

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/ichharmonization

By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
(703) 538-7600
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