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    Certified Medical Writer

    BY
    Henry Harvin

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    Mode

    Online

    Duration

    24 Hours

    Quick Facts

    particular details
    Medium of instructions English
    Mode of learning Self study, Virtual Classroom
    Mode of Delivery Video and Text Based
    Frequency of Classes Weekdays, Weekends

    Course and certificate fees

    certificate availability

    Yes

    certificate providing authority

    Henry Harvin

    The syllabus

    Module 1: Introduction to Medical Writing

    • Understanding the term ‘Medical Writing’
    • Skillsets & Motivation required for Medical Writing
    • Scope & Necessities of Medical Writing
    • Valuable Salient Features
    • Planning & Layout for Medical Writing
    • Categories of Medical Writing
    • Core Areas in Medical Writing: Consumer Insights & Requirements

    Module 2: Scientific Writing

    • Scientific News
    • Scientific Reviews
    • Scientific Research Paper for Journals
    • Case Reports

    Module 3: Drug Development Process-An Overview

    • Pre-clinical Development
    • Clinical Development / Research
    • Clinical Study Designs
    • Post-Marketing Surveillance

    Module 4: Pre-clinical/ Non-Clinical Writing

    • Differences between Clinical and Non-Clinical Writing
    • About The International Conference on Harmonisation (ICH) Guidelines
    • Good Laboratory Practices
    • Non-clinical Summaries
    • Non-clinical Study Reports

    Module 5: Medical Writing for Clinical Trial

    • Investigational Medicinal product dossiers
    • The Investigator's Brochure
    • Protocol writing
    • Informed Consent
    • DSUR (Development Safety Update Report)
    • Report amendments and updates
    • Data Analytics

    Module 6: Medical Writing in post-marketing phase

    • Aggregate Reports
    • Risk Management Plans (RMPs)
    • CSR (Clinical Study Report)
    • CER (Clinical Evaluation Report)
    • PSUR (Periodic Safety Update Report)
    • PER (Performance Evaluation Report)

    Module 7: Guidelines to Publish Clinical Data

    • CONSORT (Consolidated Standard of Reporting Trials)
    • TREND (Technology Recreation Education Nature and Discovery)
    • STROBE (STrengthening the Reporting of OBservational studies in Epidemiology)
    • CARE (Compassion, Advocacy, Restoration, and Educational)
    • COREQ (COnsolidated criteria for REporting Qualitative research)
    • PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)
    • MOOSE (Meta-analysis of Observational Studies In Epidemiology)
    • STARD (Standards for Reporting of Diagnostic accuracy studies)
    • TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis)

    Module 8: Pharmacovigilance

    • Methodologies in Pharmacovigilance
    • How to Create Template Paragraph Styles ?
    • Pharmacovigilance Programme in India (PVPI)
    • Pharmacovigilance of Herbal Drugs & Medical Devices
    • Pharmacovigilance compliance & Inspections

    Module 9: Regulatory Strategies

    • Regulatory Strategies in different phases of a Clinical Trial
    • Writing for Regulatory submissions and Drug Protection Activities (IND, NDA, BLA, SNDA, ANDA)
    • Patent- Fundamental Concept

    Module 10: Techniques And Models For Medical Writing

    • Six Scientific Techniques for Medical Writing
    • Reader's Checklist: Editing & Reviewing
    • Cooperative Principles and their Requirements
    • Models for Medical Writing: Telescope and Exposition
    • Instruction for Medical / Clinical / Regulatory Writing
    • Mosaic Structure & Layout
    • Clinical Evaluation Report (CER)
    • Periodic Safety Update Report (PSUR)
    • Performance Evaluation Report (PER)

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