PharmaRegulatory affairs is the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Pharma regulatory Affairs is also referred as a government body which connects pharmaceutical company and the regulatory agencies across the world. The student enrollment to the Postgraduate and Advance Diploma courses provided by ICBio has grown tremendously during the last few years, making it one of the most sought after learning institutes for clinical research in India.

The primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to each and every stage in the process of the manufacturing and successive activities with the appropriate laws and regulations that apply to the industry.

Basic eligibility for pursuing regulatory affairs, is to have a B.Pharm qualification but in this competitive world, M.Pharm with specialization in Pharmaceutics or QA is highly preferred. The best method to enter drug regulatory affairs (DRA) is through QA (Quality Assurance). There is a high preference for experience in QA of 1–2 years in regulatory affairs.

There are multiple benefits in the career of regulatory affairs

  • Top companies prefers regulatory affairs professionals
  • Successive growth by 8% each year in the U.S. until 2026 (according to US Bureau of Labour Statistics)
  • Good schedule and pay
  • You can choose the type of regulatory career you want to pursue (submissions vs management vs strategy vs US vs Global vs devices vs diagnostics vs Pharma vs biologics vs food vs FDA vs industry, etc.)
  • You can migrate to related fields in the same industry such as Quality Assurance, Clinical Affairs, Project Management, Marketing, etc.

Innovative Centre for Biosciences, the academic wing of ICBio Clinical Research Pvt. Ltd., Bangalore, was established in 2006 by likeminded, elite professionals and academicians from various segments of the society and is presently the leading research and customized education provider in the field of Clinical Research and Healthcare.

ICBio is collaborated with University of Mysore to offer globally recognized regular certificate courses in Health Care and Clinical Research with specialization in Clinical Research, Data Management, Pharmacovigilance, and Pharma Regulatory Affairs. ICBio provide quality training to all its students and ensures optimum utilization of its training resources by adhering to ISO 9001:2008 standards.

ADVANCED DIPLOMA IN CLINICAL RESEARCH AND PHARMA REGULATORY AFFAIRS

Duration: 3 months

Class Schedule: 5 days/week

Eligibility: Bachelor degree in Life science, Pharmacy, Nursing, Biotechnology, Medical Lab Technology, Physiotherapy, Medicine, Dental, Allied Health Science from a recognized University.

Certificate :Advanced Diploma in Clinical Research and Pharma Regulatory Affairs

Duration :3 months

Classes :Weekly 5 days

Timings : 10 a.m – 2 p.m

Course Objective:

  • To educate the importance of Clinical Research and services offered by ICBio.
  • To mould students “Ready to be absorbed Clinical Research Professionals.”
  • To create awareness about the latest techniques and trends in the industry.
  • To educate about Career Prospects in the Clinical Research industry.

Eligibility

Graduates from the following stream are eligible to join

  • Life sciences
  • Pharmacy
  • Nursing
  • Dental
  • Medicine
  • Biotechnology
  • Bio medical Engineering