6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
Regulatory affairs & Quality Assurance are both crucial aspects of clinical trials & overall drug development. They are pillars of safe and effective drug development. This program provides you an opportunity to explore both these areas.
TOTAL CREDITS: 32
Next Commencement Date
Why study this program?
The domain of regulatory affairs has gained tremendous importance overtime. It is considered to be one of the main pillars of the whole drug development industry. As companies innovate and bring new products to the market, the regulatory affairs function needs to keep up, evolve and maintain oversight so that as much as possible, only safe and effective therapies make it to the marketplace. Professionals who have a thorough understanding of the regulatory processes especially from a global perspective are highly sought after in the industry. Professionals are expected to be knowledgeable about regulatory agencies such as the US FDA, EMA, MHRA, CDSCO and others. Career opportunities often come up within the pharmaceutical sector, clinical research companies, consulting agencies etc.
Clinical Quality Assurance (QA) is also a key area within the industry as professionals working in this function ensure that their organization's are following the regulations and guidelines issued by their applicable regulatory agencies. They develop standard operating procedures for their organizations, conduct internal audits for all departments and conduct trainings so that each individual is aware of the various quality control measures that are in place for the smooth running of the day-to-day operations. QA professionals usually start their career as a Quality Assurance Executive, or a Quality Assurance Associate. With experience they grow to take one more responsibilities and work as QA Manager, QA Director and so on. Many professionals experienced in QA also work as independent auditor's.
Advanced Postgraduate Diploma in Regulatory Affairs and Quality Assurance (APGDRA+QA) program is devised to meet increasing demand by industry for regulatory affairs and quality assurance professionals. APGDRA+QA program is carefully designed by the experienced faculty from the industry, especially to provide understanding of core quality assurance methods, process and practices.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: BASICS OF DRUG DEVELOPMENT
MODULE 03: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
MODULE 04: SCHEDULE Y
MODULE 05: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 06: REGULATORY REGIME – FDA, EMA & JAPAN
MODULE 07: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 08: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 09: CMC INFORMATION & GHTF OVERVIEW
MODULE 10: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 11: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING
MODULE 12: QUALITY & QUALITY MANAGEMENT
MODULE 13: THE QUALITY ASSURANCE FUNCTION
MODULE 14: AUDITS
MODULE 15: QUALITY GUIDELINES
MODULE 16: GCP/GMP/GLP
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Regulatory Affairs & Quality Assurance (APGDRA-QA) is comprehensive and has been developed and evaluated by experienced regulatory affairs and quality assurance professionals. It is fully endorsed by the industry. Not only is this online training course suitable for new graduates but also for working professionals who either wish to grow further in their regulatory affairs and/or quality assurance career, or those who wish to make a move to the regulatory affairs or clinical quality assurance domain 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 & Quality Assurance (APGDRA-QA) 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.
- Students in their final year of graduation for the above courses are also eligible to apply.
Candidates without any science background who have work experience in the pharmaceutical industry / quality assurance / regulatory affairs / allied areas may also be eligible for this program. Please discuss your case with our counsellors.
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 PG Diploma in Regulatory Affairs & Quality Assurance Course (APGD-RAQA) 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 positions such as Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Associate etc. as well as Quality Assurance related roles such as Quality Assurance Associate, Quality Assurance Executive, Quality Auditor, QA Manager among many others.
According to a report by Cutting Edgeinfo there is a widening talent gap in Regulatory Affairs departments which is a problem for small pharma. Trained Regulatory Affairs Professionals are highly sought after.