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

• Date:
  Tuesday, 21 September 2021, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

During the first day of the ‘Patients and Consumers’ (PCWP) and ‘Healthcare Professionals’ (HCPWP) Working Parties joint meeting, the Agency introduces the latest updates on COVID-19. EMA also presents on ongoing activities related with the impact of pharmacovigilance activities on healthcare and patient safety. An update on the implementation of the Clinical Trials regulation is provided.

On the second day, the PCWP/HCPWP discussion focuses on communication and stakeholder engagement topics linked with EMA’s future extended mandate and Big Data. The final part of the meeting is dedicated to topic prioritisation for 2022, key dates and activities.

Documents

Meeting summary - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 21-22 September 2021

AdoptedReference Number: EMA/314725/2021

Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 21-22 September 2021

AdoptedReference Number: EMA/364259/2021

Presentation - COVID 19 vaccines and therapeutics - An update to the PCWP/HCPWP: September 2021 (M.Cavaleri, EMA)

Presentation - Pharmacovigilance for COVID 19 Vaccines - One year of strong safety surveillance (G. Genov, P. Bahri, EMA)

Presentation - Understanding COVID-19 vaccines by healthcare professionals and patients - User testing at EU and regional level (R. Gonzales-Quevedo, EMA; C. Constantino, University of Palermo, Sicily)

Presentation - Enhancing PRAC engagement with patients and healthcare professionals (P. Bahri, EMA)

Presentation - Update on new guidance on risk minimisation measures (GVP modules XVI RMM) (N. Semis-Costa, EMA)

Presentation - Update on new guidance on risk minimisation measures (GVP modules XVI RMM) (T. Goedecke, EMA)

Presentation - Review and publication of direct healthcare professional communications (DHPCs) (M. De Verdiere, EMA)

Presentation - Reflections on publication and dissemination of DHPCs (T. Villanueva, UEMO)

Presentation - Community pharmacists’ reflections on publication and dissemination of DHPCs (J. De Belie, PGEU)

Presentation - Clinical Trial Regulation and Clinical Trials Information System (CTIS) what changes in 2022 (F. Sweeney, EMA)

Presentation - CTIS: functionalities and support for clinical trial sponsors, availability of clinical trial data to the public (F. Westerholm, EMA)

Presentation - Big Data Steering Group: workplan and deep-dive on clinical trials raw data project (F. Domergue, E. Psarelli, EMA)

Presentation - Outcome of public consultation on the registry-based studies guideline (X. Kurz, EMA)

Presentation - PCWP/HCPWP workplan 2019-2022 and EMAN Strategy to 2025 (I. Silva, EMA)

Presentation - Looking ahead into 2022: Meeting dates, new mandate and annual eligibility re-evaluation (N. Bere, EMA)

Presentation - Update on EC legal proposal for extending the mandate of the EMA (H. Boone, EMA)

Presentation - Plans for Communication and Stakeholders’ Engagement on Extended Mandate (M. Carr, EMA)