Advanced course in Regulatory Affairs

This Advanced Regulatory Affairs training program has been conceptualised and designed to meet the growing demand of the industry for professionals providing regulatory affairs and/or quality assurance training.

Beginner 5(1 Ratings) 33 Students Enrolled
Created By Cliniversity Global
What will I learn?
  • Pharma Regulatory guidelines
  • Drug RA profiles

Curriculum for this course
9 Lessons
Drug Development process
2 Lessons
Indian Regulations - Indian Scenario - D
1 Lessons
Indian Regulations - All Indian Schedules
1 Lessons
eCTD submissions
1 Lessons
CTD guidance for Industry - CDSCO
1 Lessons
US FDA guidelines on eCTD Submissions
1 Lessons
Various schedules
1 Lessons
Declaration of Helsinki and Nuremberg Code
1 Lessons
  • B.Pharm, M.Pharm and Pharm.D
  • Life Sciences
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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. 
About the instructor
  • 10 Reviews
  • 38 Students
  • 10 Courses
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Clinical Research Program Trainer
Clinical Research Program Trainer
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  • Tue, 26-Feb-2019
    Best Regulatory Affairs Course
₹5600 ₹8000
  • 9 Lessons
  • Four Month Access
  • Self Paced Learning
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