Medical writing - Overview

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Read about Medical Writing, their types (Regulatory and Educational), Medical Writing Process

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Medical writing - Overview

  1. 1. INDEX • Definition • Types of Medical Writing • Need of Medical Writing • Skills required for Medical Writing • Duties/Role of Medical Writers • Different Organizations of MW
  2. 2. MEDICAL WRITING Activity of producing Scientific documentation by a specialized writer who is typically not one of the scientists or doctors who performed/were involved in the research.
  3. 3. How Medical Writing Came into Existence • In Pharmaceutical World Medical Writing erupted as an essential field because the industry recognized it requires special skill to produce well- structured documents that present information clearly and concisely. • Clinical trials procedures are really complex, tedious and lengthy till it lead to market approval and this demand for well written, standards-compliant documents that medical and science professionals can easily and quickly read and understand.
  4. 4. Types of Medical Writing Two Types :- 1.Regulatory Medical Writing 2.Educational Medical Writing
  5. 5. Regulatory Medical Writing • It means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and are formulaic. It includes – Clinical study protocols Clinical study reports Patient informed consent forms Investigator brochures Summary documents (e.g. in Common Technical Document [CTD] format) a medical product.
  6. 6. Educational Medical Writing • It means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals for easy referral and understandings. It includes : Sales literature for newly launched drugs. Data presentations for medical conferences. Medical journal articles for nurses, physicians and pharmacists. Programs and enduring materials for continuing education (CE) or continuing medical education (CME)
  7. 7. Need of Medical Writing • Communalism - common ownership of scientific discoveries • Universalism - evaluation using universal, unbiased criteria • Disinterestedness - scientists should act selflessly • Organised scepticism - ideas tested and subjected to rigorous, structured scrutiny by peers
  8. 8. Required Skills for Medical Writing • Attention to detail • Excellent writing skills • Interpersonal skills • Organizational skills • Scientific skills
  9. 9. Keep it Clear Keep it simple: use short, familiar words Avoid jargon and acronyms Be specific Be concrete, not abstract Say what you mean and mean what you say
  10. 10. Cross Check Before and after finalizing Medical Writers should do a web tool searches for overlapping content: – prepublication – postpublication Should refer to specialist search engine (iThenticate) which uses “text fingerprinting” and “string matching” Or should go through CrossRef database (>9 billion articles)
  11. 11. Duties performed by Medical Writers • CROs conduct clinical studies and help pharmaceutical companies to get their products registered with international regulatory authorities. In general, medical writers in CROs are involved with : 1. Preparing a range of documents for concerned regulatory submissions including protocols and final reports for clinical trials, and clinical expert reports. 2. They may also be involved in the preparation of manuscripts for publication in medical journals.
  12. 12. Medical Writing Organizations • American Medical Writers Association (AMWA) • Australasian Medical Writers Association (AMWA) • European Medical Writers Association (EMWA) • Indian Medical Writers Association (IMWA).

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