Courses
Executive Diploma in Medical Writing (Online/Virtual Classroom)
The Executive Diploma in Medical Writing (Online/Virtual Classroom) is designed to enable professionals with the essential skills required to excel in the field of scientific and regulatory writing. This comprehensive program covers diverse aspects, including regulatory medical writing, publication writing, and pharmacovigilance writing. Participants will gain hands-on experience in drafting clinical study reports, protocols, systematic reviews, and regulatory submissions. The course also emphasizes ethical considerations, compliance with global guidelines (ICH-GCP) and medical editing. With insights into freelancing and corporate career paths, this program prepares candidates for a successful career in medical writing. The course will be subject to the availability of seats in the (Virtual classes scheduled once a week starting around UTC+05:30 or IST 2:00 pm) each year.
Qualification:
Bachelor of Ayurvedic Medicine and Surgery (BAMS)
Bachelor of Dental Surgery (BDS)
Bachelor of Homeopathic Medicine and Surgery (BHMS)
Bachelor of Medicine, Bachelor of Surgery (MBBS)
Bachelor of Pharmacy (B Pharm)
Bachelor of Physiotherapy (BPT)
Bachelor of Science (BSc) in Life Science (Anatomy, Animal Biology and Biotechnology, Applied Genetics, Biomedical Science, Bioscience, Biotechnology, Biotherapeutics, Blood Transfusion Technology, Botany, Clinical Virology, Genetics, Human Disease Genetics, Life Science, Medical Biochemistry, Medical Biotechnology, Medical Laboratory Technology, Medical Microbiology, Medical Pharmacology, Medical Physiology, Microbiology, Molecular Medicine & Stem Cell Technologies, Molecular Microbiology, Nursing, Physiotherapy, Reproductive and Developmental Biology, Reproductive Biology, Reproductive Genetics, Stem Cell and Regenerative Biology, Virology, Zoology, Virology and Immunology)
Bachelor of Siddha Medicine and Surgery (BSMS)
Bachelor of Unani Medicine and Surgery (BUMS)
Diploma in Pharmacy (D Pharm)
Doctor of Medicine (MD) or Doctor of Medicine (MS) in Obstetrics and Gynaecology, Andrology, Anatomy, Physiology, Biochemistry, Internal Medicine, Pharmacology, Microbiology, Pathology, Community Medicine, Urology, and other medical post-graduate clinical specialties
Doctor of Pharmacy (Pharm D)
Master of Dental Surgery (MDS)
Master of Pharmacy (M Pharm)
Master of Physiotherapy (MPT)
Master of Science (MSc) in Life Science
Key Benefits:
1. Comprehensive Skill Development – Gain expertise in regulatory, clinical, scientific, and promotional medical writing.
2. Understanding Scientific Literature – Learn to read, interpret, and summarize research papers effectively.
3. Regulatory Writing Proficiency – Master key documents like CSRs, IBs, ICFs, protocols, and regulatory dossiers.
4. Publication & Medical Journalism – Develop skills in manuscript writing, abstracts, press releases, and systematic reviews.
5. Compliance & Ethical Awareness – Understand global guidelines (ICH-GCP, CONSORT, STROBE) and ethical considerations.
6. Pharmacovigilance & Safety Reporting – Learn to write PSURs, RMPs, and adverse event reports.
7. Scientific Communication for Non-Experts – Create clear and engaging patient information leaflets and public content.
8. Medical Editing & Proofreading – Enhance accuracy, clarity, and adherence to journal or regulatory standards.
9. Career & Freelancing Opportunities – Explore corporate and freelance medical writing career paths.
10. Hands-on Capstone Project – Gain practical experience by writing a regulatory document, manuscript, or review article.
Pedagogy:
Participants will have an opportunity to interact and engage proactively with the esteemed faculty in this online/virtual classroom training course, to learn and grasp from rich experience of this expert faculty through presentation and dialogue. Participants will be evaluated based on the quality and content of the capstone project delivered and scored at the end of the course.
Content:
1. Introduction to Medical Writing – Scope, types, and career prospects
2. Understanding Scientific and Medical Literature – How to read, interpret, and summarize research papers
3. Regulatory Medical Writing – Overview of documents like CSR, IB, ICF, Protocol, and CTD
4. Clinical Study Reports (CSR) and Protocol Writing – Key components and structure
5. Publication Writing – Manuscripts, abstracts, review articles, and systematic reviews
6. Medical Journalism and Promotional Writing – Press releases, blogs, and marketing content
7. Medical Writing Guidelines and Compliance – ICH-GCP, CONSORT, STROBE, and EQUATOR guidelines
8. Ethical and Legal Considerations – Plagiarism, authorship, and conflicts of interest
9. Pharmacovigilance Writing – PSURs, RMPs, and adverse event reporting
10. Statistical Reporting in Medical Writing – Data interpretation and presentation
11. Clinical Trial Documentation – Writing informed consent forms, investigator brochures
12. Regulatory Submissions and Dossiers – FDA, EMA guidelines
13. Writing for Medical Devices and Vaccines – Special considerations
14. Systematic Reviews and Meta-Analyses – Writing methods and interpretation
15. Medical Writing Software Tools – EndNote, Mendeley, Grammarly, and referencing styles
16. Scientific Communication for Non-Experts – Patient information leaflets and public engagement
17. Medical Editing and Proofreading Techniques – Best practices for accuracy and clarity
18. Freelancing vs. Corporate Medical Writing – Career paths and job opportunities
19. Medical Graphics and Data Visualization – Creating effective tables, graphs, and infographics
20. Capstone Project – Writing a regulatory document, manuscript, or review article
What will I get on completion?
Earn a prestigious Executive Diploma certification upon successful course completion, validating your expertise and enhancing your credibility in the field of medical writing.
Faculty
Dr Siddharth Chachad is a pharmaceutical physician with more than 20 years of experience in the areas of medical affairs, drug safety and global clinical development of new medicinal products including innovative drugs, complex generics, branded generics, biologics and biosimilars, medical devices, herbals, nutraceuticals & cosmetics, advanced therapies and even vaccines. He is a strategic leader in translational research, medical affairs and drug safety with expert knowledge of legal and regulatory requirements across these areas of expertise. He is a strong proponent of clinico-regulatory innovation, digital transformation and patient centricity in the development of new medicines. His understanding of global clinical requirements has yielded successful product registrations in most regulated markets across the globe including developed markets such as EU and US, as well as emerging markets such as India, Russia, China and Brazil.
He is an acclaimed speaker at various international seminars and conferences on clinical research and pharmacovigilance, and an expert faculty in the functional areas of drug development and patient safety at the teaching and training institutes in India, Czechia and Netherlands. He has published extensively in the peer-reviewed journals and has written a book chapter on clinical development in reputed Burger's Medicinal Chemistry, Drug Discovery and Development.
Participant benefits:
1. Access to the curated GarbhaGudi IVF Centre database (excluding personally identifiable data and information) for data collection, based on article or paper publication, to enhance credibility, demonstrate expertise, support career growth and progression, and gain recognition, for participants visiting in person during the data collection process
2. Access to a state-of-the-art Research Management System (RMS) to facilitate submissions and feedback from the GarbhaGudi Scientific Review Committee and GarbhaGudi Ethics Committee, supporting research projects and the writing of original research articles or papers.
3. Participants interested in publishing will be able to access the Research Enablement and Productivity Platform (REAP), a research project execution platform par-excellence. This tool shall support the researchers or a team of researchers from “ideation to publication” research execution and documentation. REAP provides the researchers with the following functionalities for smooth execution of all stages of their research project with ease.
(i) Title & objective writing wizards.
(ii) Protocol module with commonly used algorithms to generate study design/sample size calculation/statistical methods.
(iii) A data entry module to create customized e-forms for data entry ((Electronic data capturing of individual patients’ data).
(iv) Real time data analysis module with easy-to-use analysis configuration templates
(v) A document editor
(vi) Reference/ citation manager
(vii) Notes manager
4. Stay updated on career prospects, programs, events, fellowships, internships, and workshops.
5. Sending participants resumes to potential freelance opportunities, national and multinational employers without direct engagement, to assist in changing their career profiles.
6. Build lasting collaborations and connections for professional and personal growth. Share your ideas, receive feedback, and access guidance to shape a fulfilling career.
7. Storing resumes for recruiters to find suitable profile without tailored application submission assistance.
Open to both international and national participants.
Medium of instruction for the program is English.
*The fee is exclusive of applicable taxes.
Please connect with us for additional information.
Number of Batches Per Year:
1 (May) Number of Student Intake Per Batch:
20 Duration: 5 months Fee: ₹82,500*
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