Regulatory Affaris

Program Information

Regulatory affairs are the study of understanding sound regulatory strategies in an evolving environment of clinical trials. Our students are given an in-depth study on the key features from a regulatory perspective. Our syllabus covers analysis on clarity and consistency for explicit conclusions on prescribed information that forms the basis for global approval on clinical trial applications. As graduated students, our students will acquire all necessary skills pertaining to regulatory legislation, associated approvals and permissions required to conduct high quality, national and international clinical trials.

Our programs offer an excellent syllabus at par with the skills required by the healthcare industry to work as a regulatory affair professional. The importance of roles and responsibilities of an RA Professional during the research and development of products through its entire life cycle is well prioritized by a team of medical professionals on board while designing the syllabus for our students. We keep our students updated with the all required regulatory policies, procedures and trends apart from imparting the scientific and technical skills pertaining to health care products in a clinical trial. Our study programs will add value to our students in terms of grasping and inferring the regulatory affairs keeping them well prepared to enter the real-time industry. The program aims to place our students in a rewarding and stimulating Regulatory Affairs careers in the field of clinical research and clinical trials. We enable our students to play vital roles in making safe and effective healthcare products accessible across the globe.

Benefits Of Study

Regulatory Affairs is a study that opens opportunities to ensure integration of many concepts taught to encompass the core knowledge with relevance to the medical industry. On completion of the programs, students will play an important role in organizational development using Regulatory Affairs tools and techniques in the field of Product marketing and clinical trials.

Entry Requirements

This Course Is Aimed at the Students with a Background In:

● Chemistry

● Biosciences

● Pharmacy

● Pharmacology

Oriented for Various Professionals from the Field Of:

● Medicine

● Dentistry

● Pharmacy

Career And Trends

Regulatory agencies such as US FDA, EMEA, MHRA etc has regulated industries pertaining to pharmaceutical drug development, manufacturing, and marketing. This, in turn, has paved the way for new opportunities for employing RA professionals for playing key roles in the field of Regulatory Affairs. RA Professionals are offered job security and there is a great demand for these professionals. The FDA has increased its standards and requires many RA Professionals to fill these key positions on a continuous basis.

Field Of Employment:

Regulatory Affairs professionals' liaison with regulatory health agencies such as:

● Food and Drug Administration (FDA)

● The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)