Advanced Medical Writing

This comprehensive course is tailored for individuals aiming to excel in medical writing. It covers the foundational principles, essential skills, and advanced techniques required for effective medical communication and regulatory submissions. The course also delves into medico marketing, digital medical writing, and best practices for managing the review process.

Module 1 : Foundations of Medical Writing

  • Introduction to Medical Writing
  • Understanding the Clinical Research Industry
  • Differentiating Clinical Research from Clinical Trials
  • The Role of Medical Writers

Module 3 : Medical Terminology and Abbreviations

  • General Medical Terminology
  • Common Prefixes and Suffixes
  • Terminology Specific to Clinical Research
  • Abbreviations Used in Clinical Research

Module 5 : Basics of Biostatistics

  • Fundamentals of Biostatistics
  • Data Collection and Processing
  • Sampling Techniques
  • Descriptive Statistics and Normal Distribution

Module 7 : Medical Writing in Clinical Research

  • Protocol Design
  • Consent Document Preparation
  • Case Report Forms (CRFs)
  • Safety Reporting and Clinical Study Reports (CSRs)

Module 9 : Latest Updates in Clinical Trials

  • ICH-GCP E6 R3
  • New Drugs and Clinical Trials Rules (2019 Amendments)
  • CDSCO Notices and NABH Ethics Standards

Module 11 : Dossier Preparation and eCTD Submissions

  • Understanding CTD and e-CTD Formats
  • Quality, Efficacy, and Safety Sections
  • Standardization Templates for Regulatory Submissions

Module 13 : Digital Medical Writing

  • Creating Medical Blogs
  • Crafting Effective Advertisements
  • Freelancing Opportunities

Module 2 : Competencies for Medical Writers

  • Essential Skills for Medical Writers
  • Strategies for Effective Scientific Communication
  • Key Work Functions and Critical Behaviours
  • Managing Outsourcing, Alliances, and Client Relationships

Module 4 : Research, Writing Techniques, and References

  • Utilizing PubMed, MedlinePlus, and Other Databases
  • Effective Content Research and Writing Techniques
  • Referencing Styles for Medical Writing

Module 6 : Scientific Writing

  • Crafting Abstracts
  • Conducting Literature Reviews
  • Writing Original Research Articles
  • Documenting Case Reports

Module 8 : Ethics and Good Clinical Practices (GCP)

  • Evolution of Ethics in Clinical Trials
  • ICH Guidelines and GCP E6 R3
  • ICMR Guidelines
  • Addressing Unethical Practices

Module 10 : Regulatory Writing

  • IND, NDA, ANDA, BLA, PMA Applications
  • Biologics License Applications
  • Premarket Approval Documentation

Module 12 : Medico Marketing

  • Deliverables in Medico Marketing
  • Product Marketing Strategies
  • Campaign Design and Implementation

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure