Why Study Drug Regulatory Affairs?

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There have been several scientific revolutions in the pharmaceutical sector. New and advanced medicines and drugs are being discovered. Regulatory Affairs play a vital role in checking the quality of the products of the companies.

Regulatory Affairs is a body that supervises the manufacturing, testing and trial processes of medicines and drug items and ensures they are of better quality and do not have any fatal side effects on humans. They check if their rules and regulations are followed and then approve. 

Learning about regulatory laws will surely boost one’s career. Advanced Diploma in Drug Regulatory Affairs is a one-year program that teaches students about the laws of regulatory affairs and the regulations of its working.

Topics Covered By the Program

The following are the topics covered in the ADDRA program that are core aspects of Regulatory Affairs: 

  1. Pharmaceutical Drug Regulatory Affairs
  2. General Pharmaceutical Laws and Guidelines
  3. Drug Regulatory Affairs in India
  4. Information and Quality Management
  5. Regulatory Documentation
  6. Clinical Trials and Health Care Policies
  7. International Licensing
  8. Regulatory Considerations in Biopharmaceuticals

Why is it Important?

The course aids the students in understanding the various concepts of regulatory affairs, its procedures, rules and regulations. The program is a comprehensive study of procedures to review regulatory documents and processes for conducting clinical trials. They ensure the food and drug products will not hamper consumers’ health.

Where They Are Used

The laws of regulatory affairs apply to the drug and food industries. In the manufacturing industries for food, medical and biological products, new products are researched and developed, clinically tested, reviewed and later monitored for their effects on people.

Careers in Drug Regulatory Sectors

The program opens up vast career opportunities for the students where they can apply and grow.

  1. Regulatory Affairs Specialists help acquire government agencies’ approval for food, medicines and biochemical products and devices.
  1. Food Safety Inspector checks the quality of the food products, the components used in them, the production procedure, and the hygiene protocol followed.
  1. Clinical Research Associates collaborate with doctors, researchers and counselors to perform clinical trials of the products.
  1. Regulatory Affairs Associates work with various divisions to collect information, perform assessments, review processes and coordinate with external agencies. 
  1. Regulatory Affairs Consultants work with the companies to advise them on regulatory rules and regulations that their products must comply with.
  1. Regulatory Affairs Analysts educate businesses on the changing rules and regulations, policies and practices.

Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard (Deemed to be University)

One can earn an Advanced Diploma in Drug Regulatory Affairs (ADDRA) online from Jamia Hamdard (Deemed to be University). The program aims to offer students comprehensive knowledge about the pharmacy industry and pharmaceutical regulations at national and international levels. The curriculum helps students secure jobs in various pharmacy sectors, licensing companies and regulatory offices.

Duration: 1 Year. 

Eligibility: The applicants must have a degree in B.Pharma/MBBS/BUMS or a Bachelor’s Degree in Science from a recognized University.

To pursue a flourishing career in Drug Regulatory Affairs, click here.