European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
Table of contents
The first joint meeting of the new mandate (2022-25) of the ‘Patients and Consumers’ (PCWP) and ‘Healthcare Professionals’ (HCPWP) Working Parties will begin with introduction of the members followed by a discussion on issues related with clinical trials and the ongoing review of the ICH E6(R3) Good Clinical Practice. The second day will continue with an update on COVID-19, Big Data activities and also the use of communications by patients and healthcare professionals. The final session will look ahead to the new mandate with the adoption of the PCWP/HCPWP work plan 2022-2025 and a call for Co-chairs of the working parties.
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Draft agenda - PCWP/HCPWP joint meeting (PDF/179.75 KB)
Draft
First published: 19/05/2022
EMA/72089/2022 -
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Presentation - 3.1 Update on objectives, progress and timelines of ICH GCP E6 revision - M Bonelli and C Mihaescu (EMA) (PDF/167.43 KB)
First published: 13/06/2022 -
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Presentation - 4.1 Update on vaccines and therapeutics - M Cavaleri (EMA) (PDF/2.14 MB)
First published: 13/06/2022 -
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Presentation - 4.2 Safety surveillance on vaccines and therapeutics - G Genov, C Zaccaria, P Bahri (EMA) (PDF/1.12 MB)
First published: 07/07/2022 -
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Presentation - 4.3 Opening our Procedures at EMA to Non-EU authorities (OPEN) pilot - M Harvey (PDF/750.06 KB)
First published: 13/06/2022 -
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Presentation - 5.1 General update on big data - P Arlett (EMA) (PDF/770.27 KB)
First published: 13/06/2022 -
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Presentation - 5.2 Pilot on raw data analysis - E Psarelli (EMA) and A Bradshaw (AE) (PDF/892.19 KB)
First published: 13/06/2022 -
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Presentation - 5.3 DARWIN EU - A Segec (EMA), A Maggioni (ESC) and E Vroom (UPPMD) (PDF/695.23 KB)
First published: 13/06/2022 -
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Presentation - 6.1 Use of EMA communications - E Fleck (PDF/2.99 MB)
First published: 13/06/2022 -
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Presentation - 7.1 Feedback from streamlining eligibility self-certification - N Bere (PDF/423.33 KB)
First published: 13/06/2022 -
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Presentation - 7.3 Election of co-chairs - I Silva (EMA) (PDF/230.12 KB)
First published: 13/06/2022 -
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Meeting summary - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 1-2 June 2022 (PDF/178.62 KB)
First published: 14/07/2022
COVID-19 update
- Update on vaccines and therapeutics - Marco Cavaleri (EMA)
- Safety surveillance on vaccines and therapeutics - Priya Bahri (EMA) and Cosimo Zaccaria (EMA)
- Opening our Procedures at EMA to Non-EU authorities (OPEN) pilot - Martin Harvey (EMA) and Victoria Palmi Reig (EMA)
Big Data
- General update - Peter Arlett (EMA)
- Pilot on raw data analysis - Eftychia-Eirini Psarelli (EMA) and Angela Bradshaw (AE)
- DARWIN EU® - Andrej Segec (EMA), Aldo Maggioni (ESC) and Elizabeth Vroom (UPPMD)