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US FDA and Health Canada: Joint Regional Consultation on the ICH

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10903 New Hampshire Ave

Bldg 31 Conference Center, Rm 1503 (Great Room)

Silver Spring, MD 20993

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The Food and Drug Administration (FDA) is announcing a regional public meeting entitled ‘‘United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’’ to provide information and receive comments on the current activities of ICH as well as the upcoming meetings in Kobe, Japan scheduled for June 4 through 7, 2018. The purpose of the public meeting is to solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Kobe. The topics for discussion at this public meeting include the current guidelines under development under the ICH that will be discussed at the forthcoming ICH Assembly Meeting in Kobe. These guidelines include the following:

Topics Currently Under Regional Public Consultation (Step 3 of ICH Process):

  • S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
  • Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • E9 (R1) Addendum: Statistical Principles for Clinical Trials

Selected Topics Recently Finalized (Step 4 of ICH Process):

  • E17 General Principles on planning/designing Multi-Regional Clinical Trials

Electronic Standards and MedDRA:

  • M2 Electronic Standards for the Transfer of Regulatory Information
  • M8 Electronic Common Technical Document (eCTD)
  • E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
  • M1 MedDRA Terminology

Additional Ongoing Topics:

  • E19 Optimization of Safety Data Collection
  • E8(R1) Revision on General Considerations for Clinical Trials
  • E11A Pediatric Extrapolation
  • E14/S7B Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation
  • M9 Biopharmaceutics Classification System-based Biowaivers
  • M10 Bioanalytical Method Validation
  • S1(R1) Revision on Rodent Carcinogenicity Studies for Human Pharmaceuticals
  • S5(R3) Revision on Detection of Toxicity to Reproduction for Human Pharmaceuticals
  • Q3C(R7) Impurities: Guideline for Residual Solvents
  • Q3D(R1) Guideline on Elemental Impurities
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Date and Time

Location

10903 New Hampshire Ave

Bldg 31 Conference Center, Rm 1503 (Great Room)

Silver Spring, MD 20993

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