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Health Canada - US FDA Joint Consultation on ICH

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Sir Frederick G. Banting Research Centre

251 Sir Frederick Banting

Ottawa, ON K1Y 0M1

Canada

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Health Canada and the US FDA are holding a joint public consultation meetings on ICH guidelines.

About this Event

Health Canada and the U.S. Food and Drug Administration (FDA) are holding a joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on areas where harmonised ICH guidelines would be beneficial. Stakeholder input received through this initiative will be considered in current or future guideline development. Health Canada also intends to use these opportunities to better understand areas in drug product regulation where Canadian requirements may differ from those in place in the U.S., with a view to minimizing these differences.

This session will be offered in-person at Health Canada's Banting Auditorium in Ottawa, and via webcast. Please register for the desired ticket.

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1:00 - 1:15 PM Welcome and Overview of ICH

Nick Orphanos, Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate, Health Canada

1:15 – 1:25 PM Update on MedDRA

M1: MedDRA Terminology

Heather Morrison, Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate

1:25 – 2:10 PM Topics Recently Reaching Step 3 of ICH Process

E8(R1): Revision on General Considerations for Clinical Trials

Dr. Carole Legare, Office of Clinical Trials, Therapeutic Products Directorate, Health Canada

E19: Optimization of Safety Data Collection

Dr. Nashwa Irfan, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Canada

M10: Bioanalytical Method Validation

Dr. Anna Edmison, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada

2:10 – 3:25 PM Topics Soon to Reach Step 4 of the ICH Process

E9(R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses

Dr. Catherine Njue, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Canada

M9: Biopharmaceutics Classification System-based Biowaivers

Dr. Shereeni Veerasingham, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada

Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Dr. Anthony Ridgway, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Canada

S5(R3): Revision on Detection of Toxicity to Reproduction for Human Pharmaceuticals

Dr. Filip Kukulski, Bureau of Gastroenterology, Infection and Viral Diseases, Therapeutic Products Directorate, Health Canada

S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines

TBD

3:25 – 3:50 PM Overview of Ongoing Topics & New ICH Topics Being Launched

Dr. Celia Lourenco, Biologics and Genetic Therapies Directorate, Health Canada

New Topics:

• E6(R3): Guideline for Good Clinical Practice

• E2D(R1): Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

• E20: Adaptive Clinical Trials

• M12: Drug Interaction Studies

• Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

• S12: Biodistribution Studies for Gene Therapy Products

Ongoing Topics:

• E11A: Pediatric Extrapolation

• E14/S7B: Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation

• E17 General Principles for Planning and Design of MultiRegional Clinical Trials

• M7(R2): Addendum to Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

• M11: Clinical Electronic Structured Harmonized Protocol (CeSHarP)

• S1(R1): Revision on Rodent Carcinogenicity Studies for Human Pharmaceuticals

• Q3C(R8): Impurities: Guideline for Residual Solvents

• Q3D(R2): Impurities: Guideline on Elemental Impurities

• Q13: Continuous Manufacturing of Drug Substances and Drug Products

• Q2(R2)/Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation

• Q11 Q&As on the Selection & Justification of Starting Materials

• E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

• M8: Electronic Common Technical Document (eCTD)

• M2: Electronic Standards for the Transfer of Regulatory Information (ESTRI)

Overview of ICH Strategic Discussion Groups:

• Informal Quality Discussion Group

• Informal Generics Discussion Group

• PEpiDG: Pharmacoepidemiology Discussion Group

3:50 PM – 4:00 PM Public Comment Period

4:00 PM Closing Remarks

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Sir Frederick G. Banting Research Centre

251 Sir Frederick Banting

Ottawa, ON K1Y 0M1

Canada

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