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Tuesday, June 28 • 10:30am - 11:45am
#223: Global Harmonization: Current ICH Quality Initiatives

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Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-567-L04-P; CME 1.25; IACET 1.25; RN 1.25

The concepts described in ICH Q8, Q9, Q10, and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. It is important to have a harmonized implementation approach of these guidelines within and outside ICH regions. In addition, it is critical to focus on the commercial phase of product life cycle to be able to realize the full benefits of these guidelines. This session will discuss current ICH activities including ICH Q12 and ICH Q11 IWG. Industry speakers will share their perspectives on these initiatives and propose ways to address current technical and regulatory challenges.

Learning Objectives

Discuss current ICH activities; Examine different ways to approach technical and regulatory challenges; Recognize the importance of the guidelines within and outside of the ICH regions.

Chair

Moheb M. Nasr, PhD, MS

Speaker

A Holistic Approach for Global Management of Manufacturing Changes
Romuald Braun, MSc

ICH Q11 IWG Update
Timothy J.N. Watson, PhD

What Is Needed to Make ICH Q12 a True Transformational Guideline?
Roger Nosal


Chair
avatar for Moheb Nasr

Moheb Nasr

Vice President, CMC Regulatory Strategy, GlaxoSmithKline
Dr. Nasr is responsible for the development and the execution of CMC regulatory strategy at GSK. Prior to joining GSK, he spent over 22 yrs at FDA and established and led the Office of New Drug Quality Assessment (ONDQA). Dr. Nasr was instrumental in the development of QbD concept... Read More →

Speakers
avatar for Romuald Braun

Romuald Braun

Managing Director, uanotau gmbh
Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in Life Sciences industry. He played roles on client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Timothy Watson

Timothy Watson

Executive Director, Pfizer Inc
Tim was one of the PhRMA expert working group (EWG) members on the ICHQ11 regulatory guidance document for drug substance, and the current Rapporteur for the ICHQ11 Starting Material IWG. He is also served on the ICHQ7 IWG Q&A team, ICHQ3C EWG, and supporting many other ICH efforts... Read More →

Tuesday June 28, 2016 10:30am - 11:45am EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session