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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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Advanced Post Graduate Program in Clinical Trials & Clinical Development Safety Course Details

Recent Posts

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Regulatory Affairs Careers in India: 10 Life Sciences Organizations and the Skills Professionals Need

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Global Medical Devices Industry Outlook: Growth, Opportunities and India Perspective

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Global Pharmacovigilance: Ensuring Drug Safety for a Growing Population
Global pharmacovigilance: ensuring drug safety for a growing population

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Cros and vendor selection services in india

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Global medical device regulatory landscape

Medical Device Regulatory Affairs: Where Science Meets Strategy

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Cliniminds India Market Entry Solutions for Healthcare, Pharma & Life Sciences Growth
Cliniminds India Market Entry Solutions for Healthcare, Pharma & Life Sciences Growth

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The role of health economics and outcomes research - heor

New health economics outcomes research - heor

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Overview of the united states clinical trials market

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How to choose the right life sciences skilling institute for you

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Good Manufacturing Practice (Gmp) Audits In France: Regulatory Framework And Oversight Bodies

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White Paper: The Evolving Landscape of Global Clinical Trials (2024-2029)
White paper: the evolving landscape of global clinical trials (2024-2029)

Eastern European Clinical Trials Market: Overview and Country Breakdown
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Overview of the European Clinical Trials Market
Overview of the european clinical trials market

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Overview of the indian clinical trials market

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Cliniminds clinical data management

ROLES & RESPONSIBILITIES OF CLINICAL DATA COORDINATOR
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Regulatory Framework for Medical Devices in India: Structure, Compliance & Recent Updates

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Advancing Medical Device Quality: CRQA ISO 13485 Audit Expertise in Latin America

HEOR STUDIES
Heor studies

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Masterclass on mastering business excellence in pharmacovigilance

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Segmented overview of the latin american (south american) clinical trials market

Overview of United Kingdom Clinical Trials Market
Overview of the united kingdom clinical trials market

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Beyond Compliance: Computerized System Validation (CSV) for Pharma

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Overview of China's Clinical Trials Market
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Eastern European Clinical Trials Market: Overview and Country Breakdown
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