Clinical Trials & Pharmacovigilance
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- 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