Clinical Trials & Pharmacovigilance

  • Article 20, 31 and 107i referrals, PASS & PAES, DUS study, PSUSA, RMP
  • Clinical Trial Applications in Phase I, II and III for adult and paediatric populations.
  • Paediatric Investigation Plans (PIP), modifications, weavers, deferrals.
  • Clinical Voluntary Harmonisation Procedure (VHP).
  • Writing/critical review of Investigator Brochure, IMPD, Clinical trial applications (INDs)
  • Critical review of clinical trial protocols and clinical trial reports.
  • Response to Questions from Health Authorities and Ethics Committee
  • Assessment of substantial / non-substantial amendments, and end of trial declaration.
  • Preparation of internal GCP audit of clinical sites and GCP inspection by Health Authorities.
  • Writing of SOPs for Clinical and Regulatory Affairs Departments. Review of draft guidelines