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 Start Date
Why study this program?
Before a potential new drug can even get started with its clinical trial phases it is important to have a clear strategy in place about how the drug will be made to enter the market. What category drug will it be, how many and what type of clinical studies may need to be conducted to prove the safety and efficacy of the drug, which global markets will be approached for marketing approval etc. are important things to be considered and planned. This information is usually available in the drug's Clinical Development Plan which is put together by a team of regulatory affairs experts, medical advisors, and people in other key capacities. Regulatory affairs professionals play a crucial role as they are the ones with knowledge about the legal aspects and compliance requirements for any proposed regulatory pathway. This is just the start of the involvement of the regulatory affairs team. Regulatory affairs team submits applications with detailed documentation to the applicable regulatory authority for approval of clinical trial phases, keeps an ongoing communication with the authority as required by law and if all goes well eventually submits applications for marketing approvals. Although the process seems simple but in reality it is complex taking several years to bring a potential new drug from a phase I study to the market. Regulatory affairs departments are the cornerstone of any pharmaceutical company or CRO. There is huge demand for trained regulatory affairs professionals in the industry and it makes for an exciting and challenging career opportunity.
To ensure that all documentation submitted by the regulatory affairs departments to the regulatory agencies such as FDA is correct and up to the mark, companies employ specialized writers to write these documents in correct language and format as per the guidelines of the agency. These are medical writers. Medical writers often find themselves writing documents such as clinical trial protocols, clinical study reports, investigator brochures, consent forms, package inserts etc. all of which are part of a dossier submitted to the agency for review along with the application. Some medical writers also write material related to medico-marketing such as physician and patient information leaflets, posters, brochures etc. Some may write manuscripts for publishing in journals and magazines.
This unique program provides you an opportunity to learn both these aspects in-depth and to bring your skills to a level expected of a regulatory affairs and a medical writing professional.
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?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
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?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Advanced Post-Graduate Diploma in Regulatory Affairs & Medical Writing Course is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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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.