The document discusses medical writing, which involves producing scientific documentation for researchers who are not directly involved in the studies. It describes the need for medical writing due to the complex nature of clinical trials and regulations. There are two main types of medical writing - regulatory, which creates documents for approval processes, and educational, which makes information accessible to healthcare professionals and the public. Medical writers require skills like attention to detail, writing ability, and scientific knowledge. Their duties can include drafting protocols, reports, and manuscripts for publication.

1. in BA/BE
PRESENTED BY
• NIRMOHI TRIVEDI
• Roll No-10
• M.Sc. Sem-III
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

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
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

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.
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

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.Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

5. Types of Medical Writing
Two Types :-
1.Regulatory Medical Writing
2.Educational Medical Writing
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

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 –
 BA/BE study protocols
 BA/BE study reports
 Patient/Subject informed consent forms
 Investigator brochures
 Summary documents product.
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

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 generic 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)Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

8. Need of Medical Writing
• Communalism
• Universalism
• Disinterestednesshe (impartiality)
• Organised scepticism
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

9. Required Skills for Medical Writing
• Attention to detail
• Excellent writing skills
• Interpersonal skills
• Organizational skills
• Scientific skills
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

10. Keep it Clear
 Keep it simple: use short, familiar words
 Avoid jargon and acronyms
 Be specific
 Write what you mean
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

11. Cross Check
Before and after finalizing Medical Writers should
do a web tool searches for overlapping content:
 Pre publication
 Post publication
Should refer to specialist search engine which uses
“text fingerprinting” and “string matching”
Should go through CrossRef database
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

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.
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

13. Medical Writing Organizations
• American Medical Writers Association (AMWA)
• Australasian Medical Writers Association (AMWA)
• European Medical Writers Association (EMWA)
• Indian Medical Writers Association (IMWA).
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)

14. References
• httpww.s://mcb.illinois.edu/.../MCB%20medical%20writing%204-7-10.ppt
• http://wslideshare.net/KunalChitnis1/bioavailability-and-bioequivalence-studies
• http://www.antaea.com/our-services/bioequivalence-studies/
• http://www.amwa-dvc.org/gettingstarted/DE_Scope2005.pdf
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149406/
• www.antaea.com/our-services/bioequivalence-studies/
• bioeq.ru/en/index.php/medical-writing
• http://www.slideshare.net/mdskhan180/medical-writing-overview?qid=d1752479-
d0b6-4595-b318-a3688f17793f&v=qf1&b=&from_search=4
• http://www.slideshare.net/amandastrong/medical-writing-101-pwac?qid=d1752479-
d0b6-4595-b318-a3688f17793f&v=qf1&b=&from_search=2
• http://regulatoryconsultants.in/?page_id=90
Shivrath Center of Excellence in Clinical Research
(A joint venture with GSBTM, Govt. of Gujarat & Recognize to Gujarat University)