Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23396
• EU PAS number:
  EUPAS11379
• Study ID:
  23396
• Official title and acronym:
  Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden

  United Kingdom
• Study description:
  Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 30/11/2015

Actual: 01/06/2016

Study start date

Planned: 31/03/2015

Actual: 31/08/2016

Date of final study report

Planned: 30/11/2016

Actual: 09/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

A consortium of MAHs

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)