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Monday, June 20 • 1:15pm - 2:15pm
#112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes?

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-521-L04-P ; CME 1.00; RN 1.00

ICH Q2 (R2) and Q14 - Is the juice worth the squeeze? In this session, subject matter experts will demonstrate how ICH 02 (R2) and Q14 can lead to stronger methods and enhanced flexibility.

Learning Objectives

Discuss what kinds of method development studies can help to support established conditions for the method and apply principles of current analytical procedure development; Describe how a risk assessment can be used to evaluate impact of a method change, and aid identification of reporting category; Identify science and risk-based approaches to analytical procedure lifecycle management.


Celeste Frankenfeld Lamm, PhD


Managing the Analytical Procedure Lifecycle in the Future: Perspectives from ICH Q2(R2)/Q14
Nina S. Cauchon, PhD, RAC

ICH Q14: Analytical Procedure Development : Towards Risk-Based Lifecycle Management of Analytical Procedures – An EU Regulatory Perspective
Robert Bream, PhD, MA, MS

Lifecycle Management and Post-Approval Changes to Analytical Procedures: A Case Study
Christof Finkler, DrSc

avatar for Robert Bream

Robert Bream

Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
Rob is a pharmaceutical quality senior specialist in the EMA Quality Office, responsible for quality aspects of new and generic medicinal products from development phase via initial authorisation (MAA) to post-authorisation lifecycle management. He also coordinates the development... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Christof Finkler

Christof Finkler

Senior Technical Advisor Biotech Development, F. Hoffmann-La Roche AG, Switzerland
Christof joined Roche, working in as a team leader in biotechnology analytics in Switzerland and worked in several positions with increasing responsibilities. As Site Head Analytical Development Biochemistry he was responsible for the establishment of new analytical technologies... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
Celeste Frankenfeld Lamm, Ph.D., is currently a Director of Global Regulatory Affairs – CMC at Merck & Co, Inc. with 15 years of industry experience. In this capacity she is responsible for regulatory strategy, engagement with regulatory authorities, and preparation of clinical... Read More →

Monday June 20, 2022 1:15pm - 2:15pm CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  10: RegCMC-Product Quality, Session |   11: Statistics, Session