Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37897
• EU PAS number:
  EUPAS35947
• Study ID:
  37897
• Official title and acronym:
  Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This study analysis the content of input provided by patient and healthcare professional representatives at the public hearing and dedicated stakeholder meeting for the valproate teratogenicity and risk management assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA in 2017/2018. The content analysis applies theories on implementation of innovation in healthcare and leads to proposals to be considered by PRAC for piloting in order to enhance their engagement with patients and healthcare professionals with a view to increasing effectiveness of risk minimisation measures. The study is conducted under the PRAC Impact Strategy.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 09/03/2017

Actual: 09/03/2017

Study start date

Planned: 26/09/2017

Actual: 26/09/2017

Data analysis start date

Planned: 06/11/2017

Actual: 06/11/2017

Date of final study report

Planned: 20/05/2020

Actual: 20/05/2020

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable