REGULATORY AFFAIRS

Program Information

  • It is important to have basic understanding in Regulatory Affairs for pursuing any career pharmaceutical sector as it will help all the career aspirants specifically who are willing to opt career in Regulatory Affairs.

  • Regulatory Affairs is a multidimensional and growing profession in the Pharmaceutical field with the objective to protect public health. Regulatory professionals assure safety and efficacy of pharmaceuticals and biotechnology products, veterinary medicines, medical devices, foods, cosmetics and alternative/complementary medicines.

  • The regulatory affairs industry in India is poised for rapid growth. Most of the pharmaceutical companies have a structured regulatory affairs department in India. Moreover, various regulatory service providers have made a strong presence in India.

  • There is a high demand in the market for qualified & trained individuals in Regulatory Affairs therefore Regulatory Affairs is a good career option with immense scope in career growth.

  • Certificate Program in Regulatory Affairs will provide you a comprehensive understanding on scientific and ethical aspects of the pharmaceutical industry and will equip you with the knowledge of various regulatory guidelines simplified and explained by the industry experts from this field.

  • This training program on Regulatory Affairs is designed around the practical aspects with examples and case studies.

  • This program presents the opportunity for the students to learn the complexities in a structured manner. The program will impart an understanding of current regulatory processes from product development to commercialization, overview of key regulatory requirements in various countries and the latest trends in the pharmaceutical industry.

  • This training will be imparted by highly qualified industry experts in pharmaceutical, biotechnology and medical devices sector based on the practical expertise.

Who should attend?

For applying to the course, you should be in any of the following sectors:

  • Life Sciences (Biochemistry, Pharmacology, Toxicology, Biotechnology, Microbiology, Botany or Zoology)

  • Pharmacists (B.Pharm., M.Pharm., PhD)

  • Doctors (M.B.B.S./ B.D.S./ B.A.M.S./ B.H.M.S./ B.U.M.S./ B.V.Sc./ B.S.S.M.)

  • Bachelor’s in Physiotherapy

  • Bachelor’s/ Master’s in Nursing

 

Beginners to the Industry get the advantage of becoming ready for the industry.

The course will also be beneficial to individuals planning to switch their career to regulatory affairs.

The professionals working in various areas in the Pharmaceutical, Medical Devices, Food and Biotechnology Industry can benefit from knowing more about this vertical.

 

Curriculum

Modules & Course topics

Module 1

Introduction to Drug Regulatory Affairs

Module 2

Innovative, Generic & Hybrid Medicinal Products

Module 3

Regulatory Strategy for Product submissions

Module 4

Regulatory Requirements in Pharmaceuticals (US, Europe & India)

Module 5

Regulatory Submissions for New Applications and Lifecycle Management

Module 6

Common Technical Document (CTD)

Module 7

Electronic Common Technical Document (eCTD)

Module 8

Regulatory aspects of Biotechnology Products

Module 9

Regulations for Natural Health Products

Module 10

Regulations for Advanced Therapy Medicinal products

Careers Opportunities and Project Work