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The PERS study Work packages WP08

WP08: Regulatory issues

Leader: SOP / I Wong

Primary objective

The aim of this project is to generate new data to support a PUMA application; therefore the overall aim of the WP is to provide information necessary to fulfil and comply with the regulatory requirements of the entire project.

Secondary objectives

  1. To co-ordinate, prepare and submit the Paediatric Investigation Plan (PIP) to the EMEA.
  2. To co-ordinate, prepare and submit valid requests for clinical trials to competent authorities.
  3. To support the ethics WP in preparing an independent ethics application.
  4. To liaise with an appropriate company in the provision of the clinical trial material.
  5. To ensure Intellectual Property Rights (IPRs) issues dealt with appropriately by the Consortium.
  6. To support an appropriate pharma company in the application for a Paediatric Use Marketing Authorisation (PUMA) license.
  7. To support the sponsor in monitoring the compliance of Good Clinical Practice (GCP).