Nature of course
Free add on course
This online drugs biologics medical devices regulatory affairs course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for drug, biologic and medical devices Industry. This comprehensive drugs biologics medical devices regulatory affairs training involves the real life job simulation. Hence, the course provides practical knowledge. Moreover, this course focuses on how regulatory professionals work in the company. Therefore, it helps users to understand the key responsibilities and job functions.
In these online self-paced modules, participants understands about the development to commercialization process in detail. In other words, you will understand stages of drugs, biologics and medical devices discovery, development, investigational application, marketing authorization application, handling of different phases of clinical trial, generic approval process, Abbreviated drugs or medical devices approval process. Hence, the course covers fundamentals to advance learning on drugs, biologics and medical devices development, regulation, registration and strategic management processes.
Who should attend this course?
- Those who are in the regulatory affairs and related department.
- Professionals from drugs, biologics and medical devices industry.
- Anyone requiring an overview and detail understanding on working of regulatory affairs.
- Fresher or beginners, Those who want to make a career in the regulatory department.
Course Code: RYD-077
Title: PG Certification in Drug, Biologic and Medical Devices Regulatory Affairs
Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
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
Features of Drugs, Biologics and Medical Devices Regulatory Affairs Course
- This course covers all aspects of the drug, biologics and medical devices regulatory affairs in a single course. Hence, user need not to purchase the drugs, medical devices and biologics training separately.
- The course provides orientation to job related practical aspects of the regulatory managers. Therefore, on completion of the course, the participants will develop the hands on understanding on the regulatory affairs working.
- One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the regulatory strategic decision making.
Case Based Learning
- Advance training on drug registration requirements for various regulatory bodies.
- Access to Case Studies to learn about the drug registration steps. Hence, participants will develop advanced competency on drugs, biologics and medical devices strategic planning.
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 Regulatory Affairs
A career in Regulatory Affairs is very challenging, but highly rewarding. But at the same time, it opens up lot of opportunities for professionals. Companies always look for the trained professionals for regulatory affairs department. This is because, the regulatory job covers a variety of disciplines. Hence, Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.
Comprehensive coverage of the topic from across different regional bodies
The drug, biologic and medical devices 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 is 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 – Autrallia, NMPA – China etc. all over the world are imposing number of regulation. Moreover, 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.
About regulatory affairs job>> Learn here
Free Add on certification course
- This course comes with 2 credit of add on certification course. Hence, participants of PG Certification in Drug, Biologic and Medical Devices will receive two add on certification. One – 1 month course and also one 1-week course.
- Participant can choose add on courses of any 1 month or 1 week certification course. You can find the various available courses here.
- There will be no fees for add on courses and courses can be opted any time during the main course access period, i.e. 1 year.
- On completion of add on course, participant will be issuing course certificate.