The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

CDDF – Accelerating Clinical Trials in the EU (ACT EU)

The Cancer Drug Development Forum is an ad hoc representative of the Multi-Stakeholder Platform Advisory Group (MSP AG) under the Accelerating Clinical Trials in the EU (ACT EU).

The ACT EU initiative is run by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to transform the EU into a region that supports clinical trial development and enables collaboration and innovation at all stages of the clinical research lifecycle. As part of its efforts, the ACT EU’s Multi-stakeholder platform (MSP) functions as a vehicle for clinical trials stakeholders and regulators to come together, voice their views and collaborate to improve the clinical trials environment for European patients and citizens. 

 

The MSP enables dialogue with regulators through the creation of a MSP Advisory Group, in which the CDDF is selected to take part. The CDDF has embarked on this collaborative endeavor since January 2024 and continued its mission of accelerating the development and delivery of oncology drugs to patients.

New clinical trial map launched in the EU

[📢New clinical trial map launched in the EU ] EMA has just announced that a new clinical trial map is accessible from the public website of the Clinical Trials Information System (CTIS). The map is designed to provide patients and health care professionals with easy access to comprehensive,...

ACT EU workshop on ICH E6 R3 – broadcast details and Slido

Dear participants, Thank you for your interest in participating in upcoming ACT EU workshop on ICH E6 R3. Due to the high level of interest, the programme committee has decided that participants joining remotely should access the broadcast the event, accessible via the event page.  This will...

Forwarding Information – public consultation on the 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 from Model-Informed Drug...

ICH E6(R3) final principles & Annex 1 published

We are pleased to announce that the ICH E6(R3) principles and Annex 1 have been finalised and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which sets international standards for clinical trials involving...

Launch of MSP AG consultation on clinical trials training needs for academia and SMEs | Deadline 11 February 2025 (close of business)

We are pleased to announce the launch of the ACT EU consultation on clinical trials training needs for academia and SMEs. As a reminder, the consultation stems from ACT EU initiative’s Priority Action on clinical trials training aiming to deliver a clinical trials training curriculum for the...

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 ethical and scientific quality...

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 Guideline 6 (E6) as the global...

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 applicable. Clinical trials...

Update from ACT EU: ACT EU Helpdesk For Non-Commercial Sponsors

[ 💡 🔔 Updates from ACT EU: ACT EU Helpdesk For Non-Commercial Sponsors] ACT EU has established a dedicated helpdesk, which employs different measures to support non-commercial sponsors in navigating the clinical trial landscape in the EU. Currently, the helpdesk offers tailored technical...

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