Course Outline - Medical Writing

Duration: 12 days

Our training is designed to provide both theoretical knowledge and practical skills through interactive, guided sessions.

1. Introduction to Medical & Regulatory Writing.
• Understanding the role and scope of medical writers.
• Types of medical and regulatory documents.
2. Understanding Drug Development & Clinical Trials.
• Stages of drug discovery and development.
• Clinical trial phases (I–IV) explained.
• Role of documentation at each stage.
3. Regulatory Guidelines (ICH, FDA, EMA).
• Overview of key regulatory bodies and their functions.
• Good Clinical Practice (GCP) principles.
• Understanding ICH guidelines for clinical documents.
4. Writing Protocols, Clinical Study Reports & Investigator Brochures.
• Components and structure of each document.
• Common terminology and formatting standards.
• Practical tips for accuracy and compliance.
5. Scientific Articles, Abstracts, and Case Reports.
• Structuring manuscripts for journals.
• Writing clear, concise, and impactful abstracts.
• Case report guidelines and best practices.
6. Patient-Friendly Plain Language Writing.
• Converting technical information into simple terms.
• Creating patient education materials.
• Ethical considerations in patient communication.
7. Quality Review & Compliance Standards.
• Common quality checks and review processes.
• Ensuring adherence to regulatory requirements.
• Avoiding plagiarism and ensuring originality.
8. Project Management in Medical Writing.
• Managing timelines and deliverables.
• Collaborating with cross-functional teams.
• Tracking versions and maintaining document control.
9. Freelancing, Client Outreach & Career Launch.
• Building a professional writing portfolio.
• Finding clients on freelance platforms and LinkedIn.
• Setting rates, contracts, and payment terms.
• Maintaining long-term client relationships.