- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
Regulatory Affairs Introduction
Regulatory Affairs has been one of the most interesting and fastly expanding fields in medical sector. What makes it interesting is that Regulatory Affairs provides a career that kind of combines science, law, and business. And hence, Regulatory Affairs professionals come from various backgrounds. Regulatory Affairs makes sure that all the products align with all the regulatory standards and rules. Knowing Regulatory Affairs eligibility criteria could be beneficial for you to step into this field. But first, let us learn what exactly is Regulatory Affairs and What is its scope.
What is Regulatory Affairs?
Regulatory Affairs is a field that makes sure foods, drugs, and medical products are safe and meet the rules of use for humans. This field introduces us to how these products are developed, tested, made, sold, and distributed. Regulatory Affairs has ties with industries like drugs, medical devices, and biologics. People in the field of Regulatory Affairs make sure that manufacturers follow all the rules at all the steps while making a product. This also includes areas like Research, Clinical Research, Marketing, Manufacturing, Distribution, etc.
What is The Scope of Regulatory Affairs?
The need for Regulatory Affairs professionals in India is increasing fast. This is because the pharmaceutical market is expanding and there are more rules and challenges to follow. In 2023, the RA market in India was worth around USD 379.7 million, and it is expected to reach USD 698.2 million by 2030, growing at a rate of 9.1% each year. The biggest part of this market is regulatory writing and publishing, which made up about 36.56% of the revenue in 2023. As India wants to be a global hub for biopharmaceutical services, the demand for Regulatory Affairs professionals is on the rise. Many companies are outsourcing regulatory tasks to India because it’s more cost-effective and India has a skilled workforce. This trend is not only creating more job opportunities but also showing how important RA is in ensuring product safety and following the rules in the growing healthcare industry, which is expected to reach USD 130 billion by 2030.
Regulatory Affairs Syllabus [Updated 2024]
Introduction to Clinical Research
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Safety Reporting
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
Application, Approval And Quality Assurance in RA
- Application of Permission
- Approval of Clinical Trial
- Purpose of QA
- Responsibility of Quality Function
- Medical Devices
Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Design of Trials
- Introduction Medical Writting 1
- Drafting a study protocol
- CRF Design
- Study Design
- Informed Consent
- Trial Master File
Introduction to RA And Regulatory Bodies
- Introduction to Regulatory Affairs
- International Regulations and Initiatives
- CDSCO
- FDA – Food & Drug Administration
- FDA- An Introduction
- CFR
- CT_Rules_2019
- ICMR Guidelines
Privacy and Confidentiality
- Privacy and Confidentiality
- HIPPA
- Informed Consent Privecy
- IRB's Role in Protecting Privacy
- Data Protection
What is the Eligibility for the Regulatory Affairs Course?
You must at least have a bachelor’s degree in the fields like Life Sciences, Bio Sciences, Medicine, Pharmacy and Pharmaceutical Sciences, Nursing or Allied Health
You must have at least a score of 55% in your respective degree
Your degree should be from a recognized college or university
Why Choose TechnoBridge for Regulatory Affairs Courses
TechnoBridge is home to different interesting courses in the field of medicine. We offer attractive advantages along with the knowledge you need for Regulatory Affairs. Here, we help you meet the Regulatory Affairs eligibility criteria and start your career. Our courses are easy to access, understand, and adapt to your professional life. Here is what we offer:
Lessons from the experts with more than 29 years of experience
Unlimited placement calls, career support, and 100% Placement Assistance
Mock Interviews to make you thoroughly prepared.
Extremely affordable fees and a short duration of 2.5 months for the course
Easy to access modules along with test papers and a dynamic curriculum
Industry approved certification after completing our course
What Are The Career Opportunities in Regulatory Affairs?
The demand for skilled people in Regulatory Affairs is increasing in all across the different fields like Biotechnology, Pharmaceuticals, Cosmetics, Nutraceuticals, etc. Their work is mostly to make sure that drugs comply with regulations and rules. Career options like being a Regulatory Affairs Executive, Regulatory Affairs Officer, Manager, or Director of Regulatory Affairs could be advantageous as it has a vast salary range from ₹3,00,000 to ₹20,00,000.
Companies Hiring Regulatory Affairs Professionals in India:
- Lupin
- Emcure Pharmaceuticals
- Cognizant
- TCS (Tata Consultancy Services)
Industry approved certification after completing our course
Accutest (focuses on testing services for pharmaceuticals)
Sciformix (provides services in life sciences and regulatory affairs)
Cotivity (offers healthcare consulting and technology solutions)
Springer Nature (publishes scientific literature, including pharmaceutical research)
Docplexus (a platform for healthcare professionals, focusing on medical content and networking)
3Gen Consultancy (provides consulting services in Regulatory Affairs and compliance)
Augustus (consulting in various sectors, including pharmaceuticals)
Conclusion
To conclude, the field of Regulatory Affairs is growing at a very fast pace which makes it an amazing choice for graduates with proper Regulatory Affairs Eligibility. This field plays an important role in the Pharmaceutical industry as it has a strong foundation in science, law, and business. By learning with institutes like TechoBridge, you can get all-around knowledge along with practical experience needed for the same.