6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This online program will help you understand regulations related to clinical trials, regulatory documents that are created during the clinical trial process, how to write them and various regulatory document templates.
TOTAL CREDITS: 32
Next Commencement Date
Why study this program?
Regulatory Affairs which is one of the most important areas of clinical research creates a network of standard laws, regulations and guidelines that help to find a balance between the support of new research and the safety of participants enrolled in clinical research studies.
In the existing global pharmaceutical landscape, professionals trained in regulatory affairs spearhead global multi-country projects and ensure that clinical studies are conducted according to the requirements laid down by the local regulatory agencies as well as international bodies such as the ICH that are stakeholders in clinical research.
In addition to regulatory affairs, another domain that plays a vital role in bringing new therapies and devices to market is Medical Writing. Medical writers play their part in the development of important documents essential for approvals from regulatory agencies. Some standard documents put together by medical / scientific writers working in development are clinical study reports, clinical study protocols, informed consent forms, patient information sheets, marketing applications etc.
We at James Lind Institute, develop regulatory affairs and medical writing professionals who possess the most appropriate knowledge and skills. We achieve this via the comprehensiveness, high quality and interactivity of our unique online training programs.
The curriculum for the program - Advanced PG Diploma in Regulatory Affairs and Medical Writing (APGDRA-MW) is extensive, has been designed by experienced professionals and is fully endorsed by the industry.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA & D&C ACT
MODULE 03: SCHEDULE Y
MODULE 04: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 05: REGULATORY REGIME – FDA, EMA & JAPAN
MODULE 06: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 07: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 08: CMC INFORMATION & GHTF OVERVIEW
MODULE 09: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 10: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING
MODULE 11: BASICS OF GOOD MEDICAL WRITING
MODULE 12: COMPUTER SKILLS
MODULE 13: OVERVIEW OF THE REGULATORY, MARKETING, AND DRUG PROMOTION PROCESSES
MODULE 14: COMMON TECHNICAL DOCUMENT WRITING
MODULE 15: PROTOCOL, INVESTIGATOR’s BROCHURE & CASE REPORT FORMS
MODULE 16: CLINICAL STUDY REPORT
MODULE 17: SENTENCE CONTROL
MODULE 18: WRITING FLOW AND COHESIVENESS
MODULE 19: PUBLICATION WRITING
MODULE 20: DOCUMENTS IN MEDICO-MARKETING
MODULE 21: MANAGING THE REVIEW PROCESS
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - The Advanced Post Graduate Diploma in Regulatory Affairs & Medical Writing(APGDRA-MW) is extensive, has been developed and evaluated by experienced regulatory affairs and medical writing professionals and is fully endorsed by the industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their regulatory affairs / medical writing career, or those who wish to make a move to these areas from any other related industry.
How will I be assessed?
Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.
Am I eligible?
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Regulatory Affairs & Medical Writing (APGDRA-MW) would include either of the following:
- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health
- Any degree in English language
- Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in regulatory affairs / medical writing / allied areas. Please contact our admission representatives / counsellor to discuss your case.
What support will I receive?
Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.
Each student enrolled in the Advanced Post-Graduate Diploma in Regulatory Affairs & Medical Writing Course (APGDRA-MW) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
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This unique program allows you to explore opportunities as a regulatory affairs professional within regulatory affairs departments as well as a medical / pharmaceutical regulatory writer in medical writing departments of pharmaceutical companies, CRO's etc. You may explore job titles such as regulatory affairs associate, regulatory affairs executive, regulatory affairs manager, medical writer, regulatory writer etc.
It is highly preferable for medical writers to also have knowledge of regulatory affairs, clinical research basics, medico-marketing etc. because these are the primary areas that medical writers write for. Medical writers after gaining some work experience can also work as freelance writers i.e. work for themselves by providing writing related services to different clients.