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
Duration : 4hrs / week ( 2 days/week )
Schedule : Session of 2 hours twice a week
Batches Starting From
August 2024
Enroll Now For Early Bird Offers
Duration : 4hrs / 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 (Project Manager)
Clinical on-site exposure