This online drug regulatory affairs course provides understanding of drug regulation, drug registration process and strategic planning.
This PG Certification is designed to create effective Regulatory Affairs Manager for Pharmaceutical Industry. This Drug Regulatory Affairs training course gives practical knowledge and real life job simulation. Course focus on how regulatory professionals work in company and understanding of key responsibilities and job functions.
In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. 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. Course covers fundamental to advance learning on drug development, regulation, registration and strategic management process.
Who should attend this course?
- 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: RYD-001
Online distance learning course. So, course can be accessed online across anywhere 24×7.
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.
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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. Major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. And to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Autrallia, NMPA – China etc. all over the world are imposing number of regulation. These regulations are evolving and changing every other day. Regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. This has resulted in creation of regulatory department with certified regulatory affairs professionals. And it help companies to meet these requirements with ease.
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