ACT EU multi-stakeholder platform kick-off workshop

• Date:
  Thursday, 22 June 2023, 13:00 (CEST) - 18:30 (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

Accelerating Clinical Trials in the EU (ACT EU) Priority Action 3 aims to establish a platform where all stakeholders involved in designing, regulating, performing and participating in clinical trials can, through regular dialogue, identify relevant scientific, methodological and technological advances to develop the clinical trials environment in the EU.

Through a series of workshops to be held in 2023 and 2024, an EU multi-stakeholder platform on clinical trials will be established to advance discussions on priority topics by efficiently incorporating the views, needs and concerns of all parties involved in the process.

This two-day event offered participants the opportunity to:

•    understand different stakeholder perspectives on how to transform the EU environment for clinical trials;
•    Present and discuss the feedback obtained during the MSP public consultation;
•    Initiate discussion on priority areas identified during the public stakeholder consultation;
•    Present and discuss a proposed model for the establishment of the MSP in ACT EU.

A video recording is available below.

The meeting report is available on the ACT EU website:

• ACT EU: Meeting report - ACT EU Kick-off workshop report

Video recording

Day 1 

Day 2

 

Documents

Agenda - ACT EU multi-stakeholder platform kick off workshop

Presentation - session 1 - Accelerating Clinical Trials in the EU (ACT EU) (Monique Al, HMA-CCMO)

Presentation - Session 1 - Accelerating Clinical Trials in the EU (ACT EU) (G. Capone, EMA)

Presentation - Session 1: Panel and audience discussion on CT environment (J. Isla, European Dravet Syndrome Federation)

Presentation - Session 1: Panel and audience discussion on CT environment (L. D'Apote, EFPIA)

Presentation - Session 1: Panel and audience discussion on CT environment (S. Badreh, European Hematology Association)

Presentation - Session 1: Panel and audience discussion on CT environment (S. Gold, Charité Universitätsmedizin Berlin-CTCG)

Presentation - Session 1: ACRO Panel discussion topics (Z. Thacker, ACRO)

Presentation - Session 2: Clinical Trial Regulation and implementation update (C. Didion, EC)

Presentation - Session 2: Member States support to the CTR implementation (M. Lunzer, HMA-CTCG)

Presentation - Session 2: Panel and audience discussion on CTR (A. Michon, ECRIN)

Presentation - Session 2: Panel and audience discussion on CTR (D. Johnston, ACRO)

Presentation - Session 2: Panel and audience discussion on CTR (J. Isla, European Dravet Syndrome Federation)

Presentation - Session 2: Panel and audience discussion on ethics (D. Lo, EATRIS)

Presentation - Session 2: Panel and audience discussion on ethics (F. Greenhalgh, EATG)

Presentation - Session 2: Panel and audience discussion on ethics (M. Carson, REK KULMU, Norwegian ethics committee)

Presentation - Session 2: Panel and audience discussion on ethics (M. Zwaan, NVMETC, Dutch ethics committee)

Presentation - Session 2: panel and audience discussion on ethics (R. Stanbrook, EFPIA)

Presentation - Session 2: Panel and audience discussion on ethics - Wolfgang Berdel (AKEK, German ethics committee member)

Presentation - Session 2: Panel and audience discussion on transparency (D. Navarro Llobet, Spanish Network for Clinical Research)

Presentation - Session 2: panel and audience discussion on transparency (J. Holtzople, EFPIA)

Presentation - Session 2: Panel and audience discussion on transparency (R. Castro, EPHA)

Presentation - Session 2 - Panel and audience discussion on transparency (Z. Thacker ,ACRO)

Presentation - Session 2: The role of ethics committees in clinical trials (H. Christiansen, DKETIK, Danish Centre for Ethics)

Presentation - Session 2: Transparency of clinical trials (L. Pioppo, EMA)

Presentation - Session 3: Clinical trials in situations of public health emergency (M. Cavaleri, EMA)

Presentation - Session 3: Optimising the EU infrastructure for methodology guidance (F. Lasch, EMA) and (D. Zerlang Andersson, HMA)

Presentation - Session 3: Panel and audience discussion on non-commercial CTs (A. Michon, ECRIN)

Presentation - Session 3: Panel and audience discussion on non-commercial CTs (D. Lacombe, EORTC)

Presentation - Session 3: Panel and audience discussion on non-commercial CTs (D. Navarro Llobet, Spanish Network for Clinical Research)

Presentation - Session 3: Panel and audience discussion on non-commercial CTs (D. Lo, EATRIS)

Presentation - Session 3: Panel and audience discussion on non-commercial CTs (M. Landray, Oxford University - CTCG)

Presentation - Session 3 - Panel and audience discussion on non-commercial CTs (M. de Lemus, SMA Europe)

Presentation - Session 3: Panel and audience discussion on non-commercial CTs (Mira Zuidgeest, UMCU)

Presentation - Session 3: Panel and audience discussion on SA (D. Lacombe, EORTC)

Presentation - Session 3: Panel and audience discussion on SA (D. Lo, EATRIS)

Presentation - Session 3: Panel and audience discussion on SA (M. Mokou, Mosaiques Diagnostics).

Presentation - Session 3: Panel and audience discussion on SA (Mireille Muller, EFPIA_EuropaBio)

Presentation - Session 3: Reinforcing coordination between scientific advice and CT approval (Jane Moseley, EMA)

Presentation - Session 3: Reinforcing coordination between scientific advice and CT approval (L. O'Dwyer, HMA EU-IN)

Presentation - Session 3: Reinforcing coordination between scientific advice and CT approval (S. Petraglia, HMA-CTCG)

Presentation - Session 3: Supporting non-commercial clinical trials (E. Stahl, HMA-CTCG)

Presentation - Session 4: Opportunities from a European CT multi-stakeholder platform (G. Andrew-Nielsen, HMA)

Presentation - Session 4: Panel and audience discussion on MSP (D. Johnston, ACRO)

Presentation - Session 4: Panel and audience discussion on MSP (H. Goossens, Antwerp University Hospital)

Presentation - Session 4: Panel and audience discussion on MSP (L. Leyens, EFPIA)

Presentation - Session 4: Panel and audience discussion on MSP (M. Rataj, EPF)

Presentation - Session 4 - Panel and audience discussion on MSP (R. Giuliani, HCPWP Chair)