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

• Date:
  Wednesday, 02 March 2022
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The first ‘Patient and Consumer’ (PCWP) and ‘Healthcare Professionals’ (HCPWP) Working Parties joint meeting of 2022 will begin with an update on COVID-19 vaccines and therapeutics and safety surveillance.

The first day of the meeting will provide an update on EMA projects and initiatives, including:

• accelerating clinical trials in the EU (ACT EU),
• big data;
• electronic product information (ePI);
• the Agency’s extended mandate.

The second day of the meeting will enable discussion on advanced therapy medicinal products (ATMPs) and sharing members’ voices.

The meeting will close with looking ahead to 2022 to 2025.

Documents

Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 2-3 March 2022

Reference Number: EMA/15726/2022

Meeting summary - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 2-3 March 2022

AdoptedReference Number: EMA/775191/2021

Presentation - Update of approved and candidate COVID 19 vaccines and therapeutics (M.Cavaleri, EMA)

Presentation - Pharmacovigilance for COVID 19 Vaccines Prospects and Plans for 2022 (G.Genov, P.Bahri, C.Zaccaria, EMA)

Presentation - Accelerating Clinical Trials in the EU (ACT EU) (I.den Rooijen, F.Petavy, F.Sweeney, EMA)

Presentation - Big Data Steering Group progress report (J.Kjaer, DKMA)

Presentation - Data Analysis and Real World Interrogation Network (DARWIN EU®) (A.Segec, EMA)

Presentation - Electronic Product Information (ePI) for EU medicines (E.Scanlan, EMA)

Presentation - Update on activities linked to presence of N nitrosamines in human medicines (M.Filancia, EMA)

Presentation - Communication and Stakeholders’ Engagement Plan on extended mandate (I.Abed, EMA)

Presentation - Awareness raising on the development and evaluation of ATMPs (P.Celis, A.Hidalgo-Simon, EMA)

Presentation - European Federation for Primary Care “Convey Family Medicine principles in Health care and in Pharmaceutical care” (P.van den Hombergh, EFPC)

Presentation - European Hematology Association “Recommendations for reducing bureaucracy in Clinical Trials” (N.Bolanos, EHA)

Presentation - European Heart Network “EU Medical Device Regulation implementation and availability of cardiac devices (C. Dhen, EHN)

Presentation - European Federation of Allergy and Airways Diseases “Improving lung health through the future European Health Data Space” (I.Proano, EFA)

Presentation - International Patient Organisation for Primary Immunodeficiencies “Status of Primary Immunodeficiency Healthcare" (J.Drabwell, IPOPI)

Presentation - Call for new PCWP/HCPWP mandate 2022-2025 (I.Silva, EMA)

Presentation - PCWP/HCPWP workplan 2022-2025: development and topic prioritisation (N.Bere, EMA)

Presentation - PCWP/HCPWP 2019 -2022 working party mandate highlights (M.Mavris, EMA)

Video recordings

Day 1

Update on vaccines and therapeutics by M. Cavaleri (EMA)

Safety surveillance on vaccines and therapeutics by P. Bahri (EMA)

Accelerating clinical trials in the EU (ACT-EU) by I. Den Rooijen (EMA)

Big Data Steering Group (BDSG) by J Kaejr (BDSG)

Data Analysis and Real World Interrogation Network (DARWIN-EU) by A. Segec (EMA)

Electronic product information (ePI) by E. Scanlan (EMA)

Nitrosamines impurities by M. Filancia (EMA)

Engagement and Communication Plan by I. Abed (EMA)

Day 2

Awareness raising on the development and evaluation of ATMPs by Ana Hidalgo, Patrick Celis (EMA)