Introduction
Course Type
Course Duration
Eligibility
Certification
Features
Related Courses
About RA
Drug regulatory affairs course provides understanding of drug regulation, registration, marketing authorization submission management. Also, the course extensively covers the regulatory strategic management. 
This PG Certification is designed to create effective Regulatory Affairs Manager for Pharmaceutical Industry. Most importantly, this course provides practical knowledge and real life job simulation in the field of regulatory affairs. Hence, this course is ideal for the professionals work in regulatory affairs department. In fact, the major objective of the course is to inculcate the regulatory decision making skills for regulatory professionals.
Online Self Paced Learning
In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. Then, stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications will be covered in phased manner for easy understanding. Further more, the course will provides extensive training on dossier, drug master file, site master file preparation and filing. Above all, course covers the plant management and advanced plant certification management process in detail.
Who should attend this course?Â
- Those who are in regulatory affairs and related department.
- Professionals from drug discovery development.
- Anyone requiring an overview of drug regulatory affairs.
- Fresher or beginners, Those who want to make a career in drug regulatory department.
Course Code:Â RYD-001
Course Title: PG Certification in Drug Regulatory Affairs (PGDRA)
Online distance learning course. So, course can be accessed online across anywhere 24×7.
1 Year
Any body who wants to acquire drug regulatory affairs competency should attend the course.
Certificate will be provided at the end of the successful completion of the course
- Orientation to job related practical aspects of the drug regulatory managers, is covered in this course extensively.
- Simulation to real life working in regulatory affairs department. It help to enhance the regulatory strategic decision making.
- Advance training on drug registration requirements for various regulatory bodies.
- Access to Case Studies to learn about the drug registration steps.
Few of the similar courses
- US Pharmaceutical and Biopharmaceutical Regulatory Affairs
- Japan Drug Regulatory Affairs
- Drug Registration and Regulation in China
- Drug Discovery and Development to Commercialization
- European Drug Regulatory Affairs
- Drug Registration and Regulation in GCC countries
- UAE Drug Regulation and Registration
- Drug Registration and Regulation in Saudi Arabia
- Middle East Drug Regulatory Affairs
Career in Drug Regulatory Affairs
A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.
The Pharma and biopharma industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Hence, the major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. In fact, to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Australia, NMPA – China etc. all over the world are imposing number of regulation. Therefore, these regulations are evolving and changing every other day. Most importantly, regulatory professionals must have thorough knowledge about the updated regulations. Certainly, sound regulatory knowledge helps them to take strategic decision effectively. Hence, this has resulted in creation of regulatory department with certified regulatory affairs professionals. Therefore, it help companies to meet these requirements with ease.
About regulatory affairs job>> Learn here
Do this course provides training on medical devices regulatory affairs?
No. This course covers drug regulatory affairs. But this course does not cover medical device regulatory affairs. However, we have drug medical devices regulatory affairs, in a single course. >> Click here to Learn more.
