Season’s Greetings from the Cancer Drug Development Forum (CDDF)
From all of us at CDDF Team, we wish you a wonderful holiday season filled with peace, joy and health. Happy Holidays and a prosperous New Year!
ICH M15 Guideline on general principles for model-informed drug development
The European Medicines Agency has published for public consultation the ICH M15 Guideline on general principles for model-informed drug development. This guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived...
ICH Guideline for Good Clinical Practice E6(R3) Annex 2
The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2 Good Clinical Practice (GCP), as described in ICH E6(R3) Principles and Annex 1, is applicable across clinical trial types, designs and...
Open consultation on ICH E6 (R3) Annex 2
EMA has opened the public consultation on the draft Annex 2 of ICH E6(R3), following its adoption by EMA’s Committee for Medicinal Products for Human Use (CHMP). As part of the ICH E6 suite, this document addresses Good Clinical Practice (GCP), an international...
Upcoming ACT EU Multi-stakeholder Workshop on ICH E6 R3
As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficiency...
IMPORTANT MESSAGE FROM ACT EU
All clinical trials expected to continue beyond 30 January 2025 must be transitioned to the EU Clinical Trials Regulation (CTR) via the Clinical Trials Information System (CTIS). This date marks the end of a three-year transition period that began when the CTR became...
Multi-stakeholder Interview: Get an Inside Look at the CDDF Multi-Stakeholder Discussion on Innovation and Access in Rare Cancers
The Cancer Drug Development Forum (CDDF) is delighted to share interview clips featuring a diverse group of stakeholders from our recent Multi-Stakeholder Workshop on Innovation and Access in Rare Cancers. Held in Amsterdam on 23-24 September 2024, the meeting...
Key Takeaways from the CDDF Live Webinar on EU Clinical Trial Regulations (Nov 2024)
🔔 📢 The Cancer Drug Development Forum (CDDF) held a live webinar on “EU Clinical Trial Regulations.” on 12 November at 17:00 CET. This webinar featured two lectures given by Dr Tarec Christoffer El-Galaly (Aahrus University, DK) and Stéphanie Kromar (EORTC, BE),...
Strengthened Collaboration between CDDF and Friends of Cancer Research
🔔We are excited to announce that CDDF and Friends of Cancer Research have formed a strengthened collaboration to accelerate innovative, effective cancer care for patients. By fostering multi-stakeholder collaboration across Europe and globally, we’re committed to...