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WP4- ADR Collection Survey launched on June 11th 2014

WP4- ADR Collection Survey launched on June 11th 2014

We are pleased to announce that the SCOPE Work Package 4 – ADR Collection surveys were launched on June 11th 2014. These are the first Work Package surveys launched within the SCOPE Project.

The surveys have been distributed to all EU countries, Norway, Iceland and Lichtenstein using an online survey tool for completion by institutions at the national level (i.e. National Competent Authority, NCA).

The data collected in the WP4 survey, will be used to help develop guidance documents and templates, as well as training courses which are planned for later on in the project.

The surveys focus specifically on national ADR reporting systems, and consists of 6 parts – each Member State was asked to complete all 6 parts. 

The HALMED is the leader of the WP4, while the individual surveys have been prepared by topic lead countries as follows:

1. Audit of National Reporting Systems- topic lead HALMED (Croatia)

1a. Medication Errors- topic lead HALMED (Croatia)

2. Patient Reporting- topic lead HALMED (Croatia)

3. Awareness level- topic lead MHRA (UK)

4. Review of reporting forms- topic lead MHRA (UK)

5. Review of IT systems and special form of reports- topic lead HALMED (Croatia)

 

SCOPE Work Package Leaders conducted a short survey with all Member States prior to sending out WP4 questionnaires inquiring about their regional centres.  The majority of Member States replied that they would prefer the questionnaires to be completed by the institutions at the national level (i.e. National Competent Authority, NCA). Therefore, WP4 questionnaires are being sent to institutions at the national level only.

The deadline for submitting completed questionnaires is 11 July 2014

SCOPE is developing recommendations, guidance and training for regulators to support the EU pharmacovigilance network
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