Introduction to Regulatory Authorities World-Wide

To guarantee the efficacy and safety of pharmaceuticals, clinical trials must be controlled. Every nation has an organization under its own government that oversees healthcare products. Regulatory agencies have a crucial role in ensuring the quality, safety, and efficacy of medications that are made available to the general population. Regulatory affairs certification is mandatory to market a pharma formulation. Completing this module will enable students to understand how regulatory agencies including the agency involved in drug regulatory affairs contribute to the public's access to safer and more effective medications

Course Description

Clinical trials have to be regulated to ensure the safety and efficacy of medicinal products. Each country has its own agency to control healthcare products under its jurisdiction. The Advanced Concepts in CR LVL 5 module emphasizes the importance of regulatory authorities as a guardian to ensure the safety, efficacy and quality of drugs available to the public. Mastering this module will help the learners to realize the role of regulatory bodies in bringing better and safe drugs to its people.

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

This program will help the life science and health science graduates to learn about the global regulatory landscape. It provides in-depth learning about the regulatory authorities worldwide, regulatory compliance and governance, and a comparison of regulatory approaches in different regions.

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 this course in whatever order you choose, even though our curriculum may prescribe otherwise. Courses for regulatory affairs in pharma, medical devices regulatory affairs, drug regulatory affairs course, regulatory affairs masters etc are few of the courses in this subject.

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

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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.

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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.

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Dr. Smitha Seshagiri
Academic Mentor

Dr. Smitha Seshagiri has completed her PGDCR from Avigna Clinical Research Institute. She has an experience of 4+ years. She is also a practicing dentist and a wellness coach.

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
  • Investigators and Sub-investigators
₹5999

₹3999

  • Duration 9 hours
  • Chapters 9
  • Skill Level Beginner
  • Language English
  • Instructor Dr Divya Sunil
  • Instructor Ms Amrutha Babu
  • Instructor Dr Smitha Seshagiri
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