Full course description
The regulatory requirements for reporting clinical trials information in a timely manner has witnessed a strong commitment from pharmaceutical industry across many countries. Outsourcing is an integral strategy in this domain and the skills required to excel disclosure and anonymization requirements are in high demand for over a decade. This course will provide hands-on experience with writing and reporting to global registries e.g. ClinicalTrials.gov (US) and EudraCT (EMA). Students will also learn identification of Personal Protected Data (PPD) and Commercially Confidential Information (CCI), for anonymization of such details in regulatory submissions meant for release on health authorities website e.g. Health Canada, EMA etc.
This exercise will train the student on end-to-end transparency activities and become a functional member of the transparency team within a CRO or pharmaceutical industry.