Introduction to Regulatory Authorities World-Wide
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.
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
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
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