Module 1: Introduction to Medical Writing
This module will equip the candidate with the basics of Medical Writing. Gain skillsets and motivation required for medical writing. Know about the scope & Necessities of medical writing. Learn about the categories of Medical Writing and Core Areas in Medical Writing: Consumer Insights & Requirements
- 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
This module will help the candidate with the knowledge of Scientific Writing. Gain understanding about the Scientific news and reviews. Know extensively about the Scientific Research paper for journals
- Scientific News
- Scientific Reviews
- Scientific Research Paper for Journals
- Case Reports
Module 3: Drug Development Process-An Overview
This module will help the candidate with the knowledge of drug development process. Learn about the Pr-Clinical Development and Clinical Research. Gain understanding about the Clinical study designs and Post-marketing surveillance
- Pre-clinical Development
- Clinical Development / Research
- Clinical Study Designs
- Post-Marketing Surveillance
Module 4: Pre-clinical/Non-Clinical Writing
This module will guide you through the knowledge of Pre-Clinical or Non-clinical writing, Know the differences between clinical and non-clinical writing. Learn about the International Conference on Harmonisation (ICH) Guidelines. Gain understanding about the good laboratory practices, Non-clinical summaries, non-clinical study reports, and more
- 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
This module will guide the candidate with Medical Writing for Clinical Trial. Know about the Investigational Medical Product dossiers, investigator's brochure, and more. Learn about protocol writing and informed consent. Gain knowledge about the Development Safety Update Report, Report amendments, and updates
- 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
This module will guide the candidate with comprehensive knowledge of medical writing in the post-marketing phase. Learn about creating Risk management plans and Aggregate reports. Know about the CSR, CER, PSUR, and PER
- 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
This module will guide the candidate with the knowledge of Guidelines to publish Clinical Data. Know all the guidelines such as CONSORT, TREND, STROBE, CARE, COREQ, PRISMA, MOOSE, STARD, TRIPOD, and more
- 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
- Management System and Drug Dictionaries in PharmaCovigilance
- Pharmacovigilance Program 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
- Readers 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)
Complimentary Module 1: Soft Skills Development
- Business communication
- Preparation for the Interview
- Presentation Skills
Complementary Module2: Resume Writing
- Resume Writing

Checkout Learner's Experiences on LinkedIn

Shivangi
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Inka
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Manasa Krishna
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NITIGYA
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Smratee
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Suchita
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Venkata Eshwar
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