- 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
- Home
- Henry Harvin
- Courses
- Certified Medical Writer
Online
24 Hours
₹ 13,500 15,000
Quick facts
particular | details | ||
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Medium of instructions
English
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Mode of learning
Self study, Virtual Classroom
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Mode of Delivery
Video and Text Based
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Frequency of Classes
Weekdays, Weekends
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Course and certificate fees
Fees information
₹ 13,500 ₹15,000
certificate availability
Yes
certificate providing authority
Henry Harvin
The syllabus
Module 1: Introduction to Medical Writing
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)