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

2. INDEX
• Definition
• Types of Medical Writing
• Need of Medical Writing
• Skills required for Medical Writing
• Duties/Role of Medical Writers
• Different Organizations of MW

3. 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.

4. 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.

5. Types of Medical Writing
Two Types :-
1.Regulatory Medical Writing
2.Educational Medical Writing

6. 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.

7. 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)

8. 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

9. Required Skills for Medical Writing
• Attention to detail
• Excellent writing skills
• Interpersonal skills
• Organizational skills
• Scientific skills

10. 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

11. 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)

12. 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.

13. Medical Writing Organizations
• American Medical Writers Association (AMWA)
• Australasian Medical Writers Association (AMWA)
• European Medical Writers Association (EMWA)
• Indian Medical Writers Association (IMWA).