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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.


Moheb M. Nasr, PhD, MS


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

avatar for Moheb Nasr

Moheb Nasr

Vice President, CMC Regulatory Strategy, GlaxoSmithKline
Dr. Nasr joined GlaxoSmithKline (GSK) in September 2011 as Vice President for Global CMC Strategy. Prior to joining GSK, Dr. Nasr served as the Director of the Office of New Drug Quality Assessment (ONDQA), CDER, FDA. Dr. Nasr established and led ONDQA for 8 years. Dr. Nasr represented FDA at ICH and was instrumental in the development of QbD concept and key quality regulatory guidelines. Dr. Nasr obtained his Ph.D. degree in Chemistry at the... Read More →

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 and in cloud environments, in Europe and in US. Romuald is holding the degree of Master of Drug Regulatory Affairs in addition to diploma in Data Technology.
avatar for Roger Nosal

Roger Nosal

Vice President and Head, Global CMC, Pfizer Inc
He is accountable for development, preparation, prosecution and defense of investigational, commercial and post approval regulatory CMC submissions globally for new chemical, biological, vaccine & device candidates as well as generic and consumer health products. Roger was instrumental in establishing Pfizer’s and industry’s adoption of Quality by Design and has been an advocate for global regulatory harmonization.
avatar for Timothy Watson

Timothy Watson

Research Fellow, GCMC Advisory Office, 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 (such as Q12). Tim’s primary responsibility at Pfizer is to collaborate with Regulatory CMC team leaders, Co-Development teams (technical teams), and Pfizer Global... Read More →

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