Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations

• Date:
  Wednesday, 24 November 2021, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This meeting brings together all eligible patient and consumer and healthcare professionals organisations and members of the Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP).

The meeting focuses on the following topics:

• Future challenges and key priorities for the European Medicines Agency (EMA) and the European medicines regulatory network
• Beyond business continuity plans and EMA’s state of play in 2022
• Future challenges and key priorities for patient and healthcare professionals’ organisations
• Update on the Clinical Trials Regulation
• Collaboration between EMA and Health technology assessment bodies

Documents

Meeting summary - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations (24 Nov 2021)

Reference Number: EMA/775191/2021

Agenda - Annual PCWP/HCPWP meeting with all eligible organisations

Draft Reference Number: EMA/516784/2021

Presentation - European collaboration between regulators and Health Technology Assessment (HTA) bodies (M. Bertgen, EMA), B. Sepodes (CHMP)

Presentation - ICH E8(R1) – General Considerations for Clinical Studies – Finalised (F. Sweeney, EMA), (S. Vamvakas, EMA)

Presentation - CTR, CTIS functionalities and availability of clinical trial data to the public (P. Vankeerberghen, EMA)

Presentation - Medicine repurposing pilot project (C. Hernandez, HMA), (C. Bouygues, EMA)

Presentation - Civil society members in EMA scientific committees: an overview (M. Mavris, EMA)

Multimedia

European collaboration between regulators and Health Technology Assessment (HTA) bodies by M. Berntgen (EMA) and Bruno Sepodes (CHMP)

ICH E8 Guideline on general considerations for clinical studies by F. Sweeney (EMA) and S. Vamvakas (EMA)

Implementation of the clinical trials regulation by P. Vankeerberghen (EMA)

Medicine repurposing pilot project by C. Hernandez Garcia (HMA) and C. Bouygues (EMA)

Civil society members in EMA scientific committees: an overview by M. Mavris (EMA)