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#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-606-L04-P; CME 1.25; RN 1.25

This workshop will delve into how the science and risk-based approaches outlined in ICH Q2(2) and Q14 connect to emerging revisions in ICH Q1(R1) and Q6(R1), highlighting their combined impact on product control strategies.

Learning Objectives

Recognize how ICH guideline revisions influence analytical development in the future; Discuss the health authority view on impact that analytical measurements have on the development of the future products; Explain how to apply platform analytical procedures as a follow-up to Workshop 1.

Chair

Timothy Graul, PHD

Speaker

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Margaret Ruesch, PHD

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Philip Floyd, PHD

EMA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Peter Richardson

ANVISA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Carolina Lopes Krahn, MSC


Speakers
PF

Philip Floyd

Global Vice President, Analytical R&D, AbbVie, United States
Phil currently serves as Global VP, Analytical R&D within Development Sciences at AbbVie and previously spent 22 years at GSK with last role as Head of US Analytical Development. Phil received his PhD in Analytical Chemistry at U. of Illinois under Jonathan Sweedler, at Beckman Institute... Read More →
TG

Timothy Graul

Senior Director, Pfizer, United States
Timothy W. Graul is a Senior Director in the CMC Advisory Office at Pfizer Inc. He received his B.S. in Chemistry at James Madison University and Ph.D. in Analytical Chemistry at Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the... Read More →
CL

Carolina Lopes Krahn

Health Regulation Specialist, ANVISA, Brazil
Pharmaceutical professional with a degree in Industrial Clinical Pharmacy and a Master’s degree in Pharmaceutical Sciences. Has been working as Health Regulation Expert for Anvisa for over 12 years working as a drug product registration reviewer, quality management professional... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
MR

Margaret Ruesch

Vice President, Pfizer, United States
Margaret Ruesch is the Vice President of Analytical Research & Development, Biotherapeutics Pharmaceutical Sciences organization. Analytical R&D is responsible for developing in-depth product and process understanding, testing clinical trial materials, authoring investigational and... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Workshop

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