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

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Date

Miercuri, 1 iunie 2022, Toată ziua

Locație

Online
European Medicines Agency, Amsterdam, the Netherlands

Event summary

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.

Documents

Draft agenda - PCWP/HCPWP joint meeting

Draft Reference Number: EMA/72089/2022

English (EN) (179.75 KB - PDF)

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Presentation - 3.1 Update on objectives, progress and timelines of ICH GCP E6 revision - M Bonelli and C Mihaescu (EMA)

English (EN) (167.43 KB - PDF)

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Presentation - 4.1 Update on vaccines and therapeutics - M Cavaleri (EMA)

English (EN) (2.14 MB - PDF)

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Presentation - 4.2 Safety surveillance on vaccines and therapeutics - G Genov, C Zaccaria, P Bahri (EMA)

English (EN) (1.12 MB - PDF)

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Presentation - 4.3 Opening our Procedures at EMA to Non-EU authorities (OPEN) pilot - M Harvey

English (EN) (750.06 KB - PDF)

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Presentation - 5.1 General update on big data - P Arlett (EMA)

English (EN) (770.27 KB - PDF)

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Presentation - 3.1 Clinical study data pilot interim results - F Petavy

English (EN) (1.07 MB - PDF)

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Presentation - 5.3 DARWIN EU - A Segec (EMA), A Maggioni (ESC) and E Vroom (UPPMD)

English (EN) (695.23 KB - PDF)

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Presentation - 6.1 Use of EMA communications - E Fleck

English (EN) (2.99 MB - PDF)

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Presentation - 7.1 Feedback from streamlining eligibility self-certification - N Bere

English (EN) (423.33 KB - PDF)

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Presentation - 7.3 Election of co-chairs - I Silva (EMA)

English (EN) (230.12 KB - PDF)

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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

English (EN) (178.62 KB - PDF)

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Video recordings

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)

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