Online Regulatory Affairs Courses in India with Placement

Learn Regulatory Affairs Courses Online from industry experts with 27+ years of experience in Clinical Research & Pharmaceutical Regulatory Affairs. Our online Regulatory Affairs Courses cover all the aspects like understanding clinical research, design of trials, Safety Reporting, ETC.

Advanced 5(4 Ratings) 33 Students enrolled English
Created by Vaishali Deshpande
Last updated Mon, 01-Apr-2024
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Course overview

Online Regulatory Affairs Course

Regulatory affairs (RA) is the backbone of the healthcare industry, ensuring the safety and efficacy of medicines, medical devices, and other health products before they reach consumers. Understanding regulations and navigating the approval process is crucial for anyone involved in drug development, clinical research, or healthcare product marketing.

TechnoBridge offers best live online regulatory affairs course with 100% placement assistance. Our Online Regulatory Affairs Course equips you with the knowledge and skills to thrive in this dynamic field. The syllabus of our course designed by 27+ years industry experts in that we cover Clinical Research, Safety Reporting, GCP-IC E6, Design of Trials, Drug Development Process, QA in RA, RA & regulatory bodies, & Etc.


Course Objectives:

  • Gain a comprehensive understanding of the regulatory landscape for pharmaceuticals and medical devices.
  • Master the fundamentals of Good Clinical Practice (GCP) and international regulatory standards.
  • Navigate the drug development process from pre-clinical studies to market approval.
  • Develop expertise in clinical trial design, safety reporting, and quality assurance.
  • Understand the roles and responsibilities of various regulatory bodies.
  • Gain practical skills in preparing regulatory submissions and managing documentation.
  • Enhance your career prospects in the lucrative and in-demand field of regulatory affairs.


How to Enroll in Online Regulatory Affairs Course?

Ready to launch your career in RA? Apply online easily through our website! Simply click the "Register Now" button on the course page and fill out the application form. We'll be in touch soon to discuss your eligibility and answer any questions you may have.


Regulatory Affairs Course Eligibility

This course is designed for life science graduates, including B.Pharm/M.Pharm, B.Sc./M.Sc. (Bio, Microbiology, Nursing), and other relevant degrees. You don't need prior experience in Regulatory Affairs to join, but a strong foundation in science and analytical skills is recommended.


Online Regulatory Affairs Course Fee Structure

We offer competitive and flexible fee structures to make our course accessible to everyone.

  • Full payment: Enjoy a discount for paying upfront- 22000/- For onetime payment.
  • Installment options: Spread the cost over convenient installments – 25000/- For 2 installments.


Course Methodology

Our interactive learning approach ensures you gain the most from your studies:

    Live online sessions: Learn from industry experts in real-time through engaging lectures and discussions.

      27+ years experienced trainer: Our trainer has 27+ years’ cumulative experience in regulatory affairs, clinical research, pharmacovigilance & etc.

      Case studies and assignments: Apply your knowledge to real-world scenarios and hone your practical skills.

      Mock interviews: Gain confidence and prepare for job interviews with personalized feedback.

      Unlimited placement support: Benefit from our dedicated placement team that connects you with top companies in the field.


      Regulatory Affairs Course Syllaus

      The curricullum is meticulously designed to cover all aspects pf regulatory affairs

        • Module 1: Introduction to Clinical Research
        • Module 2: Drug Development Process
        • Module 3: Good Clinical Practice (GCP)-ICH E6
        • Module 4: Design of Trials
        • Module 5: Safety Reporting
        • Module 6: RA and Regulatory Bodies
        • Module 7: Application, Approval and Quality Assurance in RA
        • Module 8: Privacy and Confidentiality
        • Module 9: Practical Exercises & Case Studies
        • Module 10: Career Guidance & Placement Assistance


          Why Choose TechnoBridge for Regulatory Affair Course?

          • Industry-experienced faculty: Learn from renowned experts with extensive practical experience in regulatory affairs.
          • Comprehensive curriculum: Gain in-depth knowledge of all aspects of RA, from basic principles to advanced applications.
          • Interactive learning environment: Engage in live sessions, discussions, and practical exercises to solidify your understanding.
          • Career-focused guidance: Get personalized assistance with resume writing, interview preparation, and job placement.
          • Affordable and flexible fee structure: Choose from various payment options to fit your budget.
          • Lifetime access to course materials: Continue learning and revisiting key concepts even after course completion.


          Career Opportunities in Regulatory Affairs

          The regulatory affairs field offers a plethora of exciting and rewarding career options. With our comprehensive training, you can pursue fulfilling roles in various domains, including:

          • Clinical research associate (CRA).
          • Quality assurance (QA) specialist
          • Medical writer
          • Pharmacovigilance specialist
          • Regulatory consultant
          • Project manager


          Type of companies hiring RA professionals

          • Pharmaceutical companies
          • Biotechnology companies
          • Medical device companies
          • Contract research organizations (CROs)
          • Regulatory consultancies
          • Government agencies


          RA professional can get employment as

          • Associate/Specialist: Entry-level roles responsible for specific tasks within the RA department.
          • Manager/Head: Lead regulatory teams and oversee entire project lifecycles.
          • Consultant: Provide independent expertise to companies on a contractual basis.
          • Director: Drive regulatory strategy at the executive level.

          What will i learn?

          • Knowledge of Regulatory Affairs industry
          • You will be job ready for Regulatory Affairs domain
          • Basics of Clinical Research and its Terminologies
          • Stake holders of Clinical Research
          • What is the career pathway in Regulatory Affairs
          • Process of drug development and understand different clinical trials phases
          • In depth study of how clinical trial are conducted along with some case studies.
          • Study of Good Clinical Practices
          • Will be gaining profound knowledge of informed consent
          • Will look at the purpose of essential document requirements
          • Clinical Data Management
          Requirements
          • Ideally who has completed their graduation in science, pharmacy or ailed branch also who are interested in medicine field
          Curriculum for this course
          94 Lessons 14:10:15 Hours
          Introduction to clinical research
          5 Lessons 00:39:49 Hours
          • Introduction to Clinical Research
            00:15:29
          • Terminologies in Clinical Research
            00:16:32
          • Advantages of CR in India
            00:07:48
          • Introduction to Clinical Research - Notes
            .
          • Introduction to Clinical Research Quiz
            00:00:00
          Drug Development Process
          9 Lessons 01:39:25 Hours
          • BA/BE Studies
            00:18:49
          • Overview of Drug Development
            00:22:54
          • Clinical trial phase 0
            00:04:05
          • Clinical trial phase I
            00:19:41
          • Clinical trial phase II
            00:10:57
          • Clinical trial phase III
            00:15:33
          • Clinical trial phase IV
            00:07:26
          • Drug Development Process - Notes
            .
          • Drug Development Quiz
            00:00:00
          Good Clinical Practice (GCP)-ICH E6
          10 Lessons 02:48:41 Hours
          • History Development of International Regulations in Clinical Research
            00:18:14
          • Good Clinical Practices
            00:12:04
          • Ethics committee
            00:13:46
          • Investigator Responsibilities
            00:13:40
          • Sponsor Responsibilities
            00:38:22
          • Protocol and Investigator Brochure
            00:06:56
          • Essential Documents
            00:34:04
          • Good Clinical Practices- Notes
            .
          • Good Clinical Practices- Quiz
            00:00:00
          • Responsibilities of Ethics Committee Members
            00:31:35
          Introduction to Regulatory Affairs
          9 Lessons 02:37:06 Hours
          • Introduction to Regulatory Affairs
            00:09:41
          • International Regulations and Initiatives
            00:17:18
          • FDA- An Introduction
            00:20:18
          • CDSCO
            00:16:30
          • Code of Federal Regulation (CFR)
            00:15:10
          • CT_Rules_2019
            00:30:06
          • ICMR Guidelines
            00:48:03
          • MCQs Introduction to Regulatory Affairs And Regulatory Bodies
            .
          • References and links for clinical research regulations
            .
          Design of Trials
          8 Lessons 02:25:49 Hours
          • CRF_Design_2
            00:26:16
          • Introduction Medical Writting
            00:14:01
          • Drafting a study protocol
            00:30:56
          • Study Design
            00:27:58
          • Informed Consent
            00:31:53
          • Trial Master File
            00:08:01
          • E Trial Master File
            00:06:44
          • Design of Trial- Notes
            .
          Application and Approvals
          5 Lessons 01:32:24 Hours
          • Purpose of QA Documentation
            00:26:59
          • Responsibilities of Quality Functions
            00:13:24
          • Application of Permission
            00:15:29
          • Approval of Clinical Trial
            00:13:13
          • Medical Devices
            00:23:19
          Safety Reporting
          12 Lessons 01:15:23 Hours
          • Adverse Event Reporting
            00:22:38
          • Recording of Event
            00:11:15
          • Medical Management of Adverse Events
            00:09:43
          • Handling Death
            00:04:22
          • Unblinding of Drug
            00:02:47
          • Clinical Safety and Pharmacovigilance
            00:24:38
          • E2A- Clinical Safety and Data Management
            .
          • Media 436
            .
          • Naranjo Assessment
            .
          • Order and Formulate to Determine the Quantum
            .
          • SAE Reporting
            .
          • Safety Reporting- Quiz
            00:00:00
          Privacy and Confidentiality
          7 Lessons 01:11:38 Hours
          • Privacy and Confedentiality
            00:14:44
          • HIPPA
            00:17:30
          • Informed Consent Privacy
            00:04:04
          • IRB's Role in Protecting Privacy
            00:09:06
          • Data Protection
            00:26:14
          • References Privacy and confidentiality
            .
          • MCQs Privacy and confidentiality
            .
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          About instructor

          Vaishali Deshpande

          90 Reviews | 780 Students | 15 Courses
          Student feedback
          5
          4 Reviews
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          Reviews

          • Poonam Helode
            It was great experience of this online regulatory affairs course. Training with proper knowledge which helps me to get my dream job.
          • Parag Zambare
            Really job oriented regulatory affairs course. This way of the training is always better for all who want to learn real time regulatory affairs. Training quality was quit good and my trainer Vaishali ma'am is very supportive she was guided me very well and helps to grow my clinical research knowledge.
          • Awais Shaikh
            very nice course
          • Tanay Killekar
            The course covers all the aspects as per guidelines, taught in a lucid language, making the concepts clear. The flexible timing makes this course beneficial for working professionals. The doubt clearing session helps the candidate analyse its knowledge. I would recommend this couese to those aspiring to develop a career into RA.
          37000 Rs 27000 Rs
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