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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
Student feedback
Reviews
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Poonam HelodeIt was great experience of this online regulatory affairs course. Training with proper knowledge which helps me to get my dream job. -
Parag ZambareReally 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.
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Awais Shaikhvery nice course
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Tanay KillekarThe 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.
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