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Advanced Post Graduate Program in Clinical Trials & Clinical Development Safety

pharmaceutical business analytics distance course

Distance Learning

✔ CPD Accredited - Continuing Professional Development
✔ Program developed by senior industry experts
✔ eBooks – Presentation & Notes on Cliniminds LMS
✔ Cliniminds Certification after completion of program
✔ MCQ based final exams
✔ Introduction to clinical & Phases in Clinical Research | Drug safety reporting - CT & Post Marketing including cross reporting | New Drugs and Clinical Trial Rules 2019 & History of Indian Regulations | Sponsor responsibilities | Investigator responsibilities & Vendor Responsibilities | Trial Project Plan | IRB & IEC | Clinical trial design | Protocol design & Protocol Review from Safety Perspective | CRF design | Essential Documents in Clinical Research | eTMF - Overview (with a focus on Safety) | IND application with a focus on safety | Clinical study report with a focus on safety | NDA submission | Routine monitoring visit & Medical Monitoring Plan | CRF review and source data verification | Practical - Source documentation | Principles of Good clinical practices - ICH GCP; Indian GCP, Differences between Indian GCP & ICH GCP; ICMR Guidelines | Practical - Safety reporting | Drug safety reporting - SAE | Audits and inspections in clinical trial | DSURs | SMP | IB Preparation | Dictionaries used for case processing activities | Clinical Trial Regulations in US, EU, and China with a focus on Safey Reporting in IND (phase 1, II, III, IV clinical studies), Signal Management, DSURs and Annual Reports. | Study case processing understands and processing in safety database - CT Cases | Blinding and unblinding understand and processing in safety database

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