Medical Writing Course / Thesis / Research paper/ Regulatory Writing

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Dr Alpa Agrawal

Dr Alpa AgrawalDr Alpa AgrawalDr Alpa Agrawal

Dr Alpa Agrawal

Dr Alpa AgrawalDr Alpa AgrawalDr Alpa Agrawal
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Medical Content List

  

Category 0: Foundational Evidence Analysis 

  • Regulatory      Document Deep Dive & Distillation analyzing foundational regulatory      documents (CSPs, CSRs, CTDs) to create "Source of Truth"      summaries and evidence gap analyses that form the validated foundation for      all downstream medical communications.

Category 1: Medical Education (Unbiased & Scientific)

  1. CME      / CPD Content (Continuing Medical/Professional Development):
    • Needs       Assessment Analysis & Reports justifying the need for a CME
    • CME       Course Outlines & Agendas
    • CME       Slide Decks
    • E-Learning       Modules
    • Post-Activity       Assessments (Quizzes and case-based questions to measure learning       outcomes)
    • Educational       Grant Proposals

Category 2: Medical Affairs & Scientific Communications (Data Dissemination)

  1. Publications:
    • Manuscripts       for Peer-Reviewed Journals including Primary research articles, review       articles, case reports, and letters to the editor.
    • Abstracts       & Posters: For submission to major medical congresses (e.g.,       ASCO, ESC, ADA).
    • Encore       Presentations: Adapting existing posters or abstracts for different       congresses.
    • Plain       Language Summaries (PLS) now a requirement for many journals and       regulators.

  1. Medical      Information & Field Medical Support:
    • Standard       Response Letters (SRLs): Pre-approved, evidence-based answers to       common questions HCPs ask about a product.
    • Frequently       Asked Questions (FAQs) Documents: A comprehensive internal resource       for MSL and Medical Information teams.
    • MSL       Training Decks: In-depth slide decks to train the field medical team       on new clinical data, disease state, or competitor landscape.

Category 3: Advisory Boards & KOL Engagement (Insight Generation)

  1. Advisory      Board Materials:
    • Ad       Board Charters & Objectives Documents: The strategic brief       outlining the "why" of the meeting.
    • Pre-Read       Decks: Concise, unbiased backgrounders to prepare KOLs for the       discussion.
    • Moderator's       Guide: A detailed script with key questions to guide the live       discussion.
    • Post-Ad       Board Executive Summary Reports: A high-value report that distills       hours of discussion into key insights and actionable strategic       recommendations for the company

  1. KOL      Engagement Tools:
    • Scientific       Exchange Decks: Non-promotional slide decks for MSLs to use in       one-on-one discussions with KOLs.

Category 4: Promotional Medical Content (MLR-Reviewed)

  1. Marketing      & Sales Support Materials:
    • Sales       Aid / Detail Aid: with fully referenced claims.
    • Leave-Behind       Brochures: Compliant, data-driven materials for HCPs.
    • Website       Content: for brand websites (both HCP-facing and patient-facing).
    • Webinar       Scripts & Decks (Promotional): For brand-sponsored webinars       featuring a speaker.
    • Email       Marketing Copy: Compliant and engaging email content for HCP       outreach.

Category 5: Patient-Centric Content

  1. Patient      Education & Support:
    • Patient       Education Brochures/Websites
    • Treatment       Journey Guides explaining what to expect at each stage of their       treatment.
    • Physician-Patient       Discussion Guides
    • Health       Literacy-Optimized Content: Rewriting complex medical information to       be accessible to audiences with lower health literacy.

Category 6: Strategic & Internal Communications

Strategic Documents:

  • Scientific       Communication Platform (SCP): The foundational document outlining the       core scientific story and key messages for a product. 
  • White       Papers & Position Papers: Authoritative documents on a specific       topic or unmet medical need to establish thought leadership.
  • Internal       Newsletters & Updates: Keeping the company (sales, marketing,       R&D) informed about new data releases or market events.

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