Follow-Up Survey of stakeholder actions following the EMA patient registry workshops

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32041
• EU PAS number:
  EUPAS28593
• Study ID:
  32041
• Official title and acronym:
  Follow-Up Survey of stakeholder actions following the EMA patient registry workshops
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The Initiative for Patient Registries, launched in September 2015 by the European Medicines Agency (EMA), explores ways of expanding the use of patient registries by introducing and supporting a systematic and standardised approach to their contribution to the benefit-risk evaluation of medicines within the European Economic Area. Objectives of the Initiative include facilitating the use of existing patient registries as well as the establishment of new registries if none are available or adequate. At a consultative meeting in October 2016, expert stakeholders who included registry holders, patients, health care professionals (HCPs), regulators, marketing authorisation holders and applicants (MAHs/MAAs), health technology assessment (HTA) and reimbursement bodies, and European Commission representatives participated in discussions to share their views on barriers and facilitators to registry use and on optimising the use of registries for regulatory assessments. Subsequently EMA hosted four disease-specific patient registry workshops: Cystic Fibrosis (14th June 2017), Multiple Sclerosis (7th July 2017), CAR T-cell therapy Registries (9th February 2018) and Haemophilia Registries (8th June 2018). These disease areas were chosen because there was ongoing product development with new products recently approved or undergoing assessment and registries had requested support for harmonisation. Following each workshop, a report was published that included the recommendations and actions arising. Participants, who represented all of the stakeholder groups, contributed to the drafting of the reports.During October-November 2018, a survey was conducted to assess the impact of the workshops on stakeholder registry-related activities and to identify further EMA activities that could be explored to facilitate stakeholders’ work.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 13/08/2018

Actual: 13/08/2018

Study start date

Planned: 13/08/2018

Actual: 13/08/2018

Date of final study report

Planned: 13/12/2018

Actual: 13/12/2018

Sources of funding

No external funding

Regulatory

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