This document provides an overview of medical writing, including: - Defining medical writing as applying clinical research principles to develop documents that clearly describe research results and medical information. - Outlining the different types of medical writing such as regulatory, educational, and publication/presentation. - Explaining that medical writing emerged in the pharmaceutical industry to produce well-structured documents that present complex clinical trial information clearly. - Detailing the skills required for medical writing like domain knowledge, statistics, writing ability, and understanding guidelines.

1. By-
Bhagyashree Gunjikar
Sr. Medico-Marketing Executive
Rusan HealthCare Pvt. Ltd
6/9/2020 1
Medical Writing

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Flow Of Presentation
Definition
Types of Medical Writing
Need of Medical Writing
Skills Required for Medical Writing
How to Build Your Document
Cross Check
Exercise
Duties/Role of Medical Writers
Medical Writing Organizations
References

3. Medical Writing
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Activity of producing Scientific documentation by applying the principles of clinical research
in developing clinical trial documents that effectively and clearly describe research results,
product use, and other medical information
Medical writer is person with developed writing skills, typically not one of the scientists or
doctors who performed/were involved in the research

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How Medical Writing
Came into Existence
• In pharmaceutical world Medical Writing erupted as an essential field because the
industry recognized that, it requires a special skill to produce well-structured
specialdocuments that present information clearly and concisely
• Clinical trials procedures are really complex, tedious and lengthy till it lead to market
approval and this demands for well written, standards-compliant documents that
medical and science professionals can easily and quickly read and understand
Medical
Writing
- Clear
- Concise

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Types of Medical Writing
Types of Medical Writing
Medical
Journalism
Medical
Marketing of
Health Care
Products
Publication/
Presentation
Research
Document
Regulatory
Medical
Writing
Educational
Medical
Writing

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Newspaper & magazine articles. These are mostly for general public and lay people and
need to be written in simple, non-technical language.
Medical Journalism
Medical Journalism

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Educational Medical Writing
• It means writing documents about drugs, devices and biologics for general
audiences, and for specific audiences such as health care professionals (HCP) for
easy referral and understandings.
It includes:
 Sales literature for newly launched generic drugs
 E-learning modules for HCPS
 Patient education material
 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)
Educational Medical
Writing

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• Promotional literature targeted at healthcare professionals, product
monographs, brochures, handouts
• Sales force training manuals, e-learning modules
• Internet content for physicians and patients (consumers)
Medical Marketing of Healthcare Products
Medical Marketing of Health Care Products

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 Journal articles / manuscripts (research articles, case reports,
review articles)
 Abstracts
 Posters & presentations for scientific meetings and
conferences
Publication/Presentation
Publication/Presentation

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 Clinical trial protocols
 Investigators′ Brochure
 Informed Consent Documents
 Study reports
 Research proposals
Research Documents
Research Documents

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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 and BA/BE study reports
 Patient/Subject informed consent forms
 Package Inserts (prescribing information) & Patient Information Leaflets
 Clinical study reports, web synopses
 Regulatory submission documents – Common Technical Document (CTD) modules such
as nonclinical and clinical overviews & summaries, expert reports, safety & efficacy
summaries; Aggregate safety reports such as Periodic Safety Update Reports ( PSURs),
bridging reports, Periodic Adverse Drug Experience Reports (PADER), Annual safety reports
(ASR)s; policy papers etc.
Regulatory Medical Writing

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Required Skills for Medical Writing
 Domain knowledge
 Medical & therapeutic area knowledge
 Drug development process , pharmacology, drug safety
 Statistics
 Technical guidelines
 General Knowledge and Skills
 Language & grammar
 Literature / reference searching
 Interpretation and presentation of research data
 Ethical & legal issues
Skills for Medical Writing

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How to Build your Document
Take Away points to scientific documentation
 Keep it simple: use short, familiar words
 Avoid jargon and acronyms
 Be specific
 Write what you mean
 Understanding the project brief
 Literature search & review of information
 Authoring & compiling the document
 The review process Formatting & editing
 Approval and sign off
 Electronic publishing
Building Document

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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
Cross Check

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Exercise
1. Query from an HCP regarding use of Fentanyl patch in patient suffering from severe pain
2. Comparative Clinical Study for Methadone versus Morphine
3. Do you have clinical Trials for use of Methadone in Neuropathic pain
4. Pack Insert for Buprenorphine
5. Product Monograph for Tramadol

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Answer 1.
• Query should be enquired properly, w.r.t. type of patient involved, is doctor treating patient with any
other medicine.
• Literature search for the query and indication mentioned https://www.ncbi.nlm.nih.gov/pubmed/
• Any other relevant data and citing that data with proper reference style.
• Mentioning disclaimer if the use of product is off label use or any special note.
Answer 2/3.
• Do a proper literature search (use relevant keywords) on a authentic search engine (PubMed, Ovid,
Google Scholar, NIC govt Clinical trials)
• Literature search for the query and indication mentioned https://www.ncbi.nlm.nih.gov/pubmed/
• Any other relevant data and citing that data with proper reference style.
• Mentioning disclaimer if the use of product is off label use or any special note.
Answer 4.
https://www.medicines.org.uk/emc/files/pil.4163.pdf
Answer 5.
https://www.medicines.org.uk/emc/files/pil.41
63.pdf

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Duties performed by Medical Writers
• Contract research organizations (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.
Medical Writers Role

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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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References
 https://ww.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
 Sharma S. How to become a competent medical writer? Perspect Clin Res. 2010 Jan;1(1):33-7.

21. THANK YOU
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