MedWriters is thrilled to launch the Regulatory Writing Program — a 5-week journey through the most critical documents in clinical research and regulatory affairs. This program is beneficial for aspiring or practicing medical writers, life science, medical, dental or pharmacy graduates, Clinical research professionals and Regulatory affairs associates.
Program Schedule
1. Overview & Drug Development Cycle - 7 April, 7 to 9 PM
Grasp the bigger picture of how medicines move from lab to patient.
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Role of regulatory writers
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Overview of global health authorities
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Drug development lifecycle
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Types of regulatory documents
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Understanding the terminology
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FAQs in Regulatory Affairs
2. Regulatory Authorities and Guidelines - 14 April, 7 to 9 PM
Learn the role of the FDA, EMA, ICH, and GCP standards.
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ICH guidelines
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FDA & EMA submission structure (eCTD)
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Regional variations (India, Japan, EU)
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Ethics & compliance
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Compare submission requirements for FDA vs. EMA.
3. Clinical Study Protocol – Structure, Content, and Compliance - 17 April, 7 to 9 PM
Understand the blueprint of clinical trials.
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Core Writing Skills
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Purpose and importance of clinical trial protocols
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Key sections of a clinical trial protocol
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Study design, objectives, and endpoints
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Regulatory and ethical considerations (ICH-GCP)
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Mock Interview
4. Investigator’s Brochure: Structure, Content, and Purpose - 21 April, 7 to 9 PM
Communicate essential trial information to investigators.
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Purpose of the Investigator’s Brochure
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Structure and key sections of an IB
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Non-clinical and clinical data presentation
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Safety information and risk communication
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Mock Interview
5. Informed Consent Form, CSR, and Patient Narrative - 24 April, 7 to 9 PM
Translate trial data into structured, regulatory-compliant reports.
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Purpose of informed consent in clinical trials
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Essential elements of an ICD
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Ethical principles and subject rights
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Writing patient-friendly consent language
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Purpose and structure of Clinical Study Reports (CSR)
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Overview of the ICH E3 guideline
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Data presentation and interpretation in CSRs
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Patient narratives: purpose and structure
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Mock Interview
6. Common Technical Document – Overview and Structure - 28 April, 7 to 9 PM
Master submissions across global markets.
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Introduction to the CTD format
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Overview of CTD Modules 1 to 5
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Role of CTD in global regulatory submissions
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Regional considerations in CTD submissions
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Mock Interview
7. CTD Module 2 – Overview and Structure - 01 May, 7 to 9 PM
Master submissions across global markets.
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Purpose of CTD Module 2
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Structure of clinical summaries and overviews
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Summarizing clinical efficacy and safety data
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Linking Module 2 summaries with CSRs
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Mock Interview
8. Non-clinical Reports, PSUR and DSUR - 05 May, 7 to 9 PM
Monitor and report drug safety over time.
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Role of non-clinical studies in drug development
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Types of non-clinical reports
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Structure of non-clinical study reports
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Integration of non-clinical data into CTD
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Overview of aggregate safety reports
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Types of aggregate reports (PSUR, DSUR, PBRER)
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Safety data analysis and signal evaluation
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Regulatory timelines and submission requirements
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Mock Interview
9. Risk Management Plan - 08 May, 7 to 9 PM
Anticipate and mitigate potential risks.
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Purpose of risk management documentation
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Key components of a Risk Management Plan (RMP)
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Overview of Clinical Evaluation Reports (CER)
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Benefit–risk assessment principles
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Mock Interview
10. Regulatory Submission & Interview Preparation - 12 May, 7 to 9 PM
Navigate the final step toward approvals.
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Regulatory Submission
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Career opportunities in regulatory writing
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Required skills and qualifications
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Entry-level vs experienced regulatory roles
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Resume and interview preparation tips
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Mock Interview
