ICH Project Guideline Workshops
-
ICH E14/S7B Implementation Working Group: Q&A (Draft) Information Session on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects
Date: 04/17/2026 -
Workshop on ICH E22 "General Considerations for Patient Preference Studies (Draft)"
Date: January 28, 2026 -
ICH E20 "Adaptive Design for Clinical Trials (Draft)" Information Session
Date: November 04, 2025 -
ICH Q3E “Guideline for Extractables and Leachables (Draft)” Briefing Session
Date: October 10, 2025 -
ICH M4Q (R2) “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (Draft)” Briefing Session
Date: August 26, 2025 -
Workshop on ICH E21 "Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials (Draft)"
Date: Jul 23, 2025 -
Workshop on ICH Q1 "Stability Testing of Drug Substances and Drug Products" (Draft, Step 2)
Date: 06/04/2025 -
Workshop on ICH M13B Guideline (Draft) "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver"
Holding date: Apr 17, 2025 -
Briefing on ICH M15 "General Principles for Model-Informed Drug Development (Draft)
Date: Mar 19, 2025 -
ICH M14 Draft Guideline Workshops
Holding date: Jul 08, 2024 -
ICH S7B Implementation Working Group: "Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects", Mini-Symposium on In Vivo QT Best Practices Study Methodology Study Group Participation
Holding date: May 31, 2024 -
ICH E2D (R1) Draft Guideline Workshops
Holding date: May 16, 2024 -
ICH S12 Guideline Workshops
Holding date: Feb 22, 2024 -
Guideline Symposium on ICH E19 “Selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials”
Holding date: Jan. 30, 2024 -
5th ICH Forum: ICH Quality Guideline Update
Holding date: Dec. 13, 2022 -
ICH S1B (R1) Guideline Workshops
Date: Nov. 27, 2023 -
ICH Q9 (R1) Guideline Workshops
Date: Oct. 11, 2023 -
Briefing on ICH E6 (R3) "Guideline for Good Clinical Practice (Draft)"
Jul. 28, 2023 -
Workshop on ICH M13A Guideline (Draft) "Bioequivalence for Immediate-Release Solid Oral Dosage Forms"
Date: Apr. 21, 2023 -
Q&A Workshop on ICH E14/S7B "Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential"
Holding date:March 16, 2023 -
Workshop on the Draft Guideline: ICH Q5A(R2) “Viral Safety Evaluation of Biotechnolgy Products Derived from Cell Lines of Human or Animal Origin” reached Step 2
Holding date: Jan. 20, 2023 -
4th ICH Forum: ICH Efficacy Guideline Update
Holding date:December 08, 2022 -
Workshop "2nd ICH E17 Guideline: General Principles for Planning and Design of Multi-Regional Clinical Trials
Holding date:August 08, 2022 -
ICH Q2(R2) / Q14: Briefing session on the draft guideline "ICH Q2(R2): Validation of Analytical Procedures" and "ICH Q14: Analytical Procedure Development" reached in Step 2
Holding date:June 20, 2022 -
Guideline Workshops on the draft guideline "ICH E11A: Extrapolation in Pediatric Drug Development
Holding date: Jun 09, 2022 -
Briefing on eCTD v4.0 (ICH M8) Notification Amendment and Operationalization
Holding date: Mar 11, 2022 -
Briefing on ICH Q12 "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management"
Holding date: Dec 03, 2021 -
ICH Quality Forum
Holding date: Dec 14, 2021 -
Briefing on ICH Q13: Draft Guideline for Continuous Manufacturing of Drug Substances and Drug Products Reached in Step 2
Holding date: Oct. 19, 2021 -
Briefing on ICH S5 and S11
Holding date: September 30, 2021 -
ICH S12: Briefing on the draft guideline "Approach for Nonclinical Biodistribution Considerations for Gene Therapy Products" (draft) that reached Step 2
Holding date:August 10, 2021 -
ICH S1B (R1): Briefing on the draft guideline "Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals" which reached Step 2
Jul. 20, 2021 -
ICH Public Web Conference on the latest discussion of ICH E6 Guideline (ICH-GCP)
Date: May 18 and 19, 2021 -
ICH E6 (R3) "GCP Renovation Seminar
Dates: March 15 and 29, 2021 -
ICH M8 eCTD v4.0 Revision Notification Briefing
Date: June 10, 2020 -
ICH E8 "General Guidelines for Clinical Trials" Revision (Draft) Briefing Session
Date:July 25, 2019 -
ICH E19 "Optimization of Safety Data Collection" Information Session
Date: Jul 02, 2019 -
ICH Q12 "Life Cycle Management of Pharmaceuticals" Information Session
Date:March 15 and 29, 2018 -
ICH M8 eCTD v4.0 related notification overview
Date: 08/08/2017 -
ICH Q7 "GMP Q&A for Active Pharmaceutical Ingredients" Briefing Session
Date: 04/21/2016 -
ICH Q3D Guideline Workshops and Training Materials
Date: 03/11/2016 -
ICH M7,Q3D Step 4 Guideline Workshops
Date: 04/07/2015 -
ICH M8 (Electronic Application Form) Step 2 Implementation Guide briefing
Date: 03/09/2015 -
ICH M7 (Mutagenic Impurities) Guideline Workshops
Date: 09/29/2014 -
Workshop on ICH Guidelines for Quality Implementation Working Group Notes
Date: Feb 15, 2013 -
ICH E2C (R2) Guideline Workshops
Date: Jan 18, 2012 -
ICH S6 (R1) Guideline Workshops
Date: 09/05/2011 -
ICH Q11 Guideline Workshops
Holding date: August 05, 2011 -
ICH E2B (R3) Implementation Guide information session
Holding date: July 11, 2011 -
ICH Q8, Q9, Q10 Guideline Operational Practices Workshop Follow-up
Date: Apr 25, 2011 -
ICH Q8, Q9, Q10 Guideline Implementation Workshop
Date:October 25-27, 2010 -
ICH E2B (R3) Implementation Guide information session
Date:February 17, 2010 -
ICH E2F Step 2 Guideline Workshops
Date:October 02, 2008