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Virtual | Virtual

Event Title
US-Canada Regional ICH Consultation
May 11, 2022

Date:
May 11, 2022
Time:
1:00 PM - 4:00 PM ET

Agenda

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Topics & Presentations

Speakers

US-Canada Regional ICH Consultation – Part 1

 

Opening Remarks

Theresa Mullin, PhD,
Associate Director for Strategic Initiatives
CDER | FDA

Overview of ICH

Jill Adleberg
ICH Coordinator
Office of the Center Director (OCD) | CDER | FDA

Topics Recently Reaching Milestones:

 

E11A, Paediatric Clinical Trials Extrapolation

Lynne P. Yao, MD
Director
Division of Pediatric and Maternal Health (DPMH) | CDER | FDA

Q9(R1), Quality Risk Management

Rick Friedman
Deputy Director
Office of Manufacturing Quality | CDER | FDA

Q2/Q14, Analytical Validation

 

Muhammad Shahabuddin, PhD
Chief, Laboratory of Biochemistry, Virology and Immunochemistry
Division of Biological Standards and Quality Control (DBSQC),
Office of Compliance and Biologics Quality (OCBQ) | CBER | FDA

US-Canada Regional ICH Consultation – Part 2

Topics Recently Reaching Milestones, Continued:

 

E14/S7B, Clinical Evaluation of Qt/QTc Interval Prolongation and
Proarrhythmic Potential QnA

David Strauss, MD, PhD
Director
Division of Applied Regulatory Science (DARS)
Office of Translational Science (OTS) | CDER | FDA

Q3D(R3), Revision for Cutaneous and Transdermal Products

Alisa Vespa, PhD
Senior Scientific Evaluator
Therapeutic Products Directorate| Health Canada

Questions & Answers Panel

Joining the panel in Rick Friedman’s stead is:

Alexey Khrenov, PhD
CMC Reviewer
Office of Tissues and Advanced Therapies | CBER | FDA

ABOUT THIS MEETING

FDA and Health Canada will be co-hosting a regional public meeting to provide information and solicit input prior to the next ICH biannual Assembly and Management Committee meetings scheduled for May 21 - 25, 2022.

The public meeting will include discussion of harmonization guidelines recently reaching significant ICH milestones.

TOPICS COVERED

  • ICH Background
  • ICH Guidelines Reaching Key Milestones

INTENDED AUDIENCE

North American regulators, industry, and other stakeholders interested in learning more about current efforts conducted under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and harmonize scientifically-driven, global standards for safe, effective, and high-quality pharmaceuticals.

FDA RESOURCES

 
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