ICH Project Guideline Briefing Session
-
ICH E20 "Adaptive Design for Clinical Trials (Draft)" Information Session
Date: November 04, 2025 -
ICH Q3E "Draft Guidelines for Extractables and Eluates for Pharmaceuticals" Information Session
Date:October 10, 2025 -
ICH M4Q (R2) "CTD - Guideline for the Preparation of Quality Documentation (Draft)" Information Session
Date: August 26, 2025 -
ICH E21 "Inclusion of Pregnant and Lactating Women in Clinical Trials (Draft)
Date: July 23, 2025 -
Briefing on ICH Q1 "Draft Guideline for Stability Studies of Active Pharmaceutical Ingredients and Dosage Forms" (Step 2 document)
Date: 06/04/2025 -
Briefing on ICH M13B "Bioequivalence of Immediate Release Oral Solid Dosage Forms - Additional Content Biowaiver" draft guideline
Holding date: Apr 17, 2025 -
Briefing on ICH M15 "General Principles for Model-Informed Drug Development (Draft)
Date: Mar 19, 2025 -
Briefing on ICH M14 Draft Guideline
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 Briefing
Holding date: May 16, 2024 -
ICH S12 Guideline Briefing Session
Holding date: Feb 22, 2024 -
ICH E19 "Selective Approaches to Safety Data Collection in Certain Clinical Trials Conducted Before or After Approval in the Late Phase of Development" Guideline Symposium
Holding date: Jan. 30, 2024 -
5th ICH Forum: ICH Quality Guideline Update
Holding date: Dec. 13, 2022 -
ICH S1B (R1) Guideline Information Session
Date: Nov. 27, 2023 -
ICH Q9 (R1) Guideline Briefing Session
Date: Oct. 11, 2023 -
ICH E6(R3) "Standards for the Conduct of Clinical Studies of Pharmaceuticals" Draft Guideline Briefing Session
Jul. 28, 2023 -
ICH M13A "Bioequivalence of Immediate Release Oral Solid Dosage Forms" draft guideline information session
Date: Apr. 21, 2023 -
ICH E14/S7B: Q&A Briefing on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects
Holding date:March 16, 2023 -
Briefing on the draft guideline reaching Step 2 of ICH Q5A (R2) "Viral safety evaluation of biotechnology-applied medicinal products manufactured using human or animal cell lines" (draft)
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 the Planning and Design of Global Clinical Trials
Holding date:August 08, 2022 -
ICH Q2(R2) / Q14: Briefing session on the draft guideline "ICH Q2(R2): Analytical Method Validation" and "ICH Q14: Analytical Method Development" reached in Step 2
Holding date:June 20, 2022 -
Briefing 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 "Guidelines for Technical and Regulatory Approaches to Drug Lifecycle Management
Holding date: Dec 03, 2021 -
ICH Quality Forum
Holding date: Dec 14, 2021 -
Briefing on ICH Q13: Draft Guideline for the Continuous Production of Active Pharmaceutical Ingredients and Dosage Forms (Draft Guideline) 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 Non-clinical Biodistribution Studies of 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 Carcinogenicity Studies of Pharmaceutical Products" 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) "Seminar on GCP Renovation
Dates: March 15 and 29, 2021 -
ICH M8 eCTD v4.0 Revision Notice Briefing Session
Date: June 10, 2020 -
ICH E8 "General Guidelines for Clinical Trials" Revision (Draft) Briefing Session
Date:July 25, 2019 -
ICH E19 "Optimizing Safety Data Collection" Information Session
Date: Jul 02, 2019 -
ICH Q12 "Lifecycle Management of Pharmaceuticals" Information Session
Date:March 15 and 29, 2018 -
ICH M8 eCTD v4.0 related notification overview information session
Date: 08/08/2017 -
ICH Q7 "GMP Q&A for Active Pharmaceutical Ingredients" Briefing Session
Date: 04/21/2016 -
ICH Q3D Guidelines and Training Materials
Date: 03/11/2016 -
ICH M7,Q3D Step 4 Guideline briefing
Date: 04/07/2015 -
ICH M8 (Electronic Application Form) Step 2 Implementation Guide briefing
Date: 03/09/2015 -
ICH M7 (Mutagenic Impurities) Guideline information session
Date: 09/29/2014 -
Workshop on ICH Guidelines for Quality Implementation Working Group Notes
Date: Feb 15, 2013 -
ICH E2C (R2) Guideline information session
Date: Jan 18, 2012 -
ICH S6 (R1) Guideline information session
Date: 09/05/2011 -
ICH Q11 guideline information session
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 Briefing Session
Date:October 02, 2008