Objectives
Eligibility
Course Outline
The domain of regulatory affairs has grown tremendously in the last few decades. This growth is mainly due to increasing focus on the safety and effectiveness of drugs that enters into the market. The growth of this sector is also due to the increasing research and development that keeps taking place in this industry. Evolving technologies and new research findings call for more stringent regulatory oversight. Various steps have been taken by regulatory agencies around the world to simplify the processes for regulatory submissions and drug approvals. The sector now offers promising career opportunities across the pharmaceutical industry, contract research organizations & regulatory consulting agencies.Quality Assurance (QA) on the other hand is also a crucial cornerstone of the whole drug development process. QA departments make sure that the organization is compliant to the regulatory requirements and is following its Quality Control (QC) measures in all the tasks that it performs. QA departments helps to standardize each step of the clinical trial process. They make sure that the clinical trials are compliant to the organization's standard operating procedures, applicable regulations as well as guidelines. The QA department also usually conducts training sessions for their employees. Overall QA is a challenging function and offers excellent career opportunities and growth as well.
  • B.Pharm, M.Pharm and Pharm.D

  • Life Sciences

  • BPT, MPT, BDS, BAMS, BHMS and MBBS

  •   Drug Development process

  •   Indian Regulations - Indian Scenario - D

  •   Indian Regulations - All Indian Schedules

  •   eCTD submissions

  •   CTD guidance for Industry - CDSCO

  •   US FDA guidelines on eCTD Submissions

  •   Various schedules