European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint meeting

• Date:
  Tuesday, 3 March 2020, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

During the first day of the PCWP/HCPWP joint meeting, the focus will be on the strategies for future activities, including the Regulatory Science Strategy and the Network Strategy to 2025. In addition, an update will be provided on nitrosamine impurities-related activities and participants will discuss the review of ICH guidelines for clinical trials and GCP as well as actions emerging from the big data taskforce recommendations addressing aspects related with data sharing and data protection.

On the second day, PCWP/HCPWP members will be given feedback from the various scientific committees as well as an update on Electronic product information (ePI) activities and the CIOMS guidelines on patient involvement. In the afternoon, participants will concentrate on the topic of shortages.

Documents

Meeting summary - PCWP/HCPWP joint meeting on 3-4 March 2020

Reference Number: EMA/527554/2019

Agenda - PCWP/HCPWP joint meeting on 3-4 March 2020

Draft Reference Number: EMA/633892/2019

Presentation - 1.1 EMA recommendations from the Regulatory Science Strategy to 2025: implications for patients and healthcare professionals (T. Humphreys)

Presentation - 1.2 European Medicines Regulatory Network Strategy to 2025: introduction on the route to joint strategy, stakeholder consultation process, timelines (M. Carr)

Presentation - 3.1 Update on the activities of the HMA/EMA Task Force (J. Ferreira)

Presentation - 4.1 Renovation of ICH guidelines. What is changing and how is EMA contributing? (F. Sweeney)

Presentation - 5.1 Survey on rare disease patient perspectives on data sharing and data protection (S. Courbier)

Presentation - 5.2 Patient data platform (E. Vroom, J. Isla)

Presentation - 5.3 HMA/EMA Big data task force recommendations and future actions (N. Brun, P. Arlett)

Presentation - 6. Feedback from committee members: CAT (K. Breen)

Presentation - 6. Feedback from committee members: CHMP (F. Ventura, C. Prieto)

Presentation - 6. Feedback from committee members: COMP (D. Duarte, T. Leest)

Presentation - 6. Feedback from committee members: HMPC (Steffen Bager)

Presentation - 6. Feedback from committee members: PRAC (V. Hivert, R. Anderson)

Presentation - 6. Feedback from committee members: PDCO (J. Taminiau)

Presentation - 7.1 Update on electronic product information for EU medicines (E. Scanlan)

Presentation - 8.1 Global Guidance on patient involvement (L. Rägo)

Presentation - 8.2 Incorporating EMA and patient organisations’ experience (F. Houÿez)

Presentation - 9.1 Sharing real examples to identify specific areas where action is needed (J. de Belie)

Presentation - 9.2 Summary of discussions related with developing a concept paper on best practices to prevent shortages (C. Roffiaen)

Presentation - 9.3 Discussion on revision of the common position between patients’, consumers, and healthcare professionals’ organisations on supply shortages of medicines (F. Houÿez)