Introduction
Course Type
Course Duration
Eligibility
Certification
Features
Related Courses
About RA
Drug regulatory affairs and pharmacovigilance course provides understanding of both the domain regulation and safety in a single course. Hence, one can learn drug regulation, registration, marketing authorization submission management along with the drug safety and monitoring aspects. This dual specialization course helps user to get certified with the two separate certification, i.e. drug regulatory affairs and pharmacovigilance.
This PG Certification is designed to create effective Regulatory Affairs and pharmacovigilance Manager for Pharmaceutical Industry. Most importantly, this course provides practical knowledge and real life job simulation of both the specialization under single course. Hence, this course is ideal for the professionals who want to have knowledge and certification of both drug regulatory affairs and pharmacovigilance. In fact, the two different certificate will enrich the professional competency.
Online Self Paced Learning
In this online self-paced modules, participant will be understanding about the drug regulation, registration and safety management 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. Moreover, apart from the regulatory aspects course covers intensive training on pharmacovigilance aspects like drug safety, monitoring and pharmacovigilance strategic planning.
Who should attend this course?Â
- Those who are in drug regulatory affairs, pharmacovigilance and related department.
- Professionals from drug discovery development.
- Professionals of pharmacovigilance background who want to have in-depth knowledge about the pharmacovigilance.
- Fresher or beginners, Those who want to make a career in drug regulatory department or in pharmacovigilance.
Course Code: RYD-101
Course Title: PG Certification in Drug Regulatory Affairs and Pharmacovigilance (PGDRAPV)
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. Two separate certificates will be issued. One on drug regulatory affairs and other on pharmacovigilance.Â
- 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 and pharmacovigilance department. It help to enhance the regulatory strategic decision making.
- Advance training on drug registration requirements for various regulatory bodies in terms of the drug registration and drug safety management.
- 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
Career in Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Pharmacovigilance deals with 4 important aspects. Adverse Event Case Management including expedited reporting, Aggregate Reporting, Signal Intelligence; and Risk Management. A professionals should have excellent understanding on these aspects. The aims of pharmacovigilance within the industry are essentially the same as those of regulatory agencies; that is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit. Although the perspectives of companies and the regulatory agencies may be different they now work more and more closely together and share information. However, central pharmacovigilance units in major pharmaceutical companies in many instances are far better resourced and have much greater ‘in-house’ expertise on the safety of their particular products.
