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

Workshop on ICH E22 "General Considerations for Patient Preference Studies (Draft)"

ICH E20 "Adaptive Design for Clinical Trials (Draft)" Information Session

ICH Q3E “Guideline for Extractables and Leachables (Draft)” Briefing Session

ICH M4Q (R2) “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (Draft)” Briefing Session

Workshop on ICH E21 "Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials (Draft)"

Workshop on ICH Q1 "Stability Testing of Drug Substances and Drug Products" (Draft, Step 2)

Workshop on ICH M13B Guideline (Draft) "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver"

Briefing on ICH M15 "General Principles for Model-Informed Drug Development (Draft)

ICH M14 Draft Guideline Workshops

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

ICH E2D (R1) Draft Guideline Workshops

ICH S12 Guideline Workshops

Guideline Symposium on ICH E19 “Selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials”

ICH S1B (R1) Guideline Workshops

ICH Q9 (R1) Guideline Workshops

Briefing on ICH E6 (R3) "Guideline for Good Clinical Practice (Draft)"

Workshop on ICH M13A Guideline (Draft) "Bioequivalence for Immediate-Release Solid Oral Dosage Forms"

Q&A Workshop on ICH E14/S7B "Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential"

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

5th ICH Forum: ICH Quality Guideline Update

4th ICH Forum: ICH Efficacy Guideline Update

Workshop "2nd ICH E17 Guideline: General Principles for Planning and Design of Multi-Regional Clinical Trials

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

Guideline Workshops on the draft guideline "ICH E11A: Extrapolation in Pediatric Drug Development

Briefing on eCTD v4.0 (ICH M8) Notification Amendment and Operationalization

ICH Quality Forum

Briefing on ICH Q12 "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management"

Briefing on ICH Q13: Draft Guideline for Continuous Manufacturing of Drug Substances and Drug Products Reached in Step 2

Briefing on ICH S5 and S11

ICH S12: Briefing on the draft guideline "Approach for Nonclinical Biodistribution Considerations for Gene Therapy Products" (draft) that reached Step 2

ICH S1B (R1): Briefing on the draft guideline "Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals" which reached Step 2

ICH Public Web Conference on the latest discussion of ICH E6 Guideline (ICH-GCP)