Product identification of biologicals in ADR reports received from European clinical practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16910
• EU PAS number:
  EUPAS16909
• Study ID:
  16910
• Official title and acronym:
  Product identification of biologicals in ADR reports received from European clinical practice
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The aim of this study is to assess the level of precise identification of biologicals up to the product level in ADR reports received from European clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/05/2016

Actual: 01/05/2016

Study start date

Planned: 01/07/2016

Actual: 01/07/2016

Data analysis start date

Planned: 01/09/2016

Actual: 01/09/2016

Date of final study report

Planned: 01/04/2017

Actual: 01/04/2017

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