TrueLessons - Regulatory Affairs

Introduction to Regulatory Affairs

Regulatory Affairs courses deals with the regulatory requirements necessary for the development, approval, and marketing of pharmaceuticals, medical devices, biologics, and other health-related products. This course in Regulatory Affairs cover a broad range of topics to equip professionals with the knowledge and skills needed to navigate the complex regulatory landscape.

Course Description

To understand the need of regulation in biomedical research.

This course/ module is valid for 6 months. E- certificate can be downloaded once the student completes the course

Who should apply?

MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.

What you will learn in this course

Regulatory Affairs courses will help the life science and health science graduates to be well versed in the complexities of regulation and learn the functionalities of regulatory authorities.

Structure of Course Delivery

Regulatory Affairs courses will be made available online. It consists of several in-depth lectures delivered by a subject matter expert, appropriately supported by slides, images, and interactive materials where necessary. The delivery has a tremendous degree of versatility. A class may be paused to allow you to take notes and refer to your textbooks (not provided). If you already know a certain part of the lecture, you can rewind it to hear it again or skip a slide or two. You are free to go back over a section at a later time if you need to review it before your assessment. You are free to take the topics in these Regulatory Affairs courses in whatever order you choose, even though our curriculum may prescribe otherwise.

Benefits

Many of our students felt that the way this course is taught has made it easier for them to keep up with the intense lectures in real class— it's like having a TV remote in class to self-pace your teacher.

Visuals in the presentations aid in better comprehension by making topics easier to learn... and more difficult to forget!

Chapters

Dr Divya Sunil

Academic Mentor

Dr. Divya Sunil has graduated with a degree in Dentistry from Bangalore University and a PG Diploma in Clinical Research. She is passionately involved in training and motivating students who are new to the world of clinical research.

Dr. Divya is proficient in Pre-Clinical Studies, laws governing the production of drugs, designing the database for Clinical studies, medical coding, and guidelines for post-marketing surveillance.

Previously, Dr. Divya has worked as an academic mentor at a private dental college in Bangalore where she has taught more than 10,000 students. She has also co-authored an article in the monthly journal,” TRENDS IN PROSTHODONTICS” VOL 4, NO. 1 (2013) on Bone Implant contact and its relationship with the strain on the surrounding bone.

Ms Amrutha Babu

Academic Mentor

Ms. Amrutha is an accomplished academic expert in the field of Food and Nutrition. She has a Master’s degree from Mahatma Gandhi University, Kottayam where she graduated with a gold medal. After undergoing training in Christian Medical College, Vellore started her career as a freelance diet counselor in 2009. She was also associated with Lybrate - an online platform for diet management and counseling.

After a remarkable experience in the field of dietetics, she received a post-graduate diploma in Clinical Research. Currently, she is associated with TrueLessons as an academic mentor. Her core strengths are providing excellent teaching and guidance to her students. Amrutha has more than 7 years of teaching experience in the field of clinical research. She has in-depth knowledge about Drug Discovery Process, Drug Approval process, Trial documents, Trial Design, Regulatory Affairs, Query writing, ICSR, and so on.

Ms Anuradha Ramachandran

Academic Mentor

Post Graduate English language trainer from Delhi University. Soft skills training certification from Carlton Management Institute A soft skills and corporate trainer with more than 30 years of training experience. Anuradha’s experience in training is reflected in the courseware, where she has included several real life situations in the form of role plays.

This program will provide the students with an opportunity to work with various MNCs.

Students can get engaged in different profiles like

Clinical Research Coordinator
Clinical Research Associate
Scientific Document Reviewer
Quality Control
Quality Analyst
Regulatory Associate
Regulatory Specialist

~~₹8000~~

₹5499

Duration 10 hours
Chapters 11
Skill Level Beginner
Language English
Instructor Dr Divya Sunil
Instructor Ms Amrutha Babu
Instructor Dr Smitha Seshagiri
Instructor Ms Anuradha Ramachandran

Introduction to Regulatory Affairs

Course Description

Who should apply?

What you will learn in this course

Structure of Course Delivery

Benefits

Chapters

INTRODUCTION TO REGULATORY AFFAIRS

ROLES AND RESPONSIBILITIES OF REGULATORY AFFAIRS PROFESSIONALS

REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS)

REGULATORY BODIES AROUND THE WORLD

FOOD AND DRUG ADMINISTRATION PART 1

FOOD AND DRUG ADMINSTRATION PART 2

THERAPEUTIC GOODS ADMINISTRATION

DRUG CONTROLLER GENERAL OF INDIA Part 1

DRUG CONTROLLER GENERAL OF INDIA PART 2

EUROPEAN MEDICINES AGENCY PART 1

EUROPEAN MEDICAL AGENCY PART 2

Dr Divya Sunil

Ms Amrutha Babu

Dr. Smitha Seshagiri

Ms Anuradha Ramachandran

₹5499