Learning Objective:
Demonstrate an understanding and skills associated with -
• Clinical research process
• Planning a clinical trial
• Preparing essential documents: Protocol, CRF, IB, ICD
• EC & Regulatory submission
• Trial Management
• SAE Reporting
• Trial Monitoring
• Drug Safety Terminology
• Causality Assessment
• Guidelines for PV - ICH, WHO
• Regulations - US, EU perspective
• Case Processing: Triage, Process, Report
• Working with MedWatch, CIOMS Forms and literature sources
• Aggregate reporting & Much More
Who is eligible?
Life science Post Graduates, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)
More Details
Visit: www.bcri.in/ph...
contact: 8480003645 for enquires
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