Introduction
Nature of course
Course Duration
Eligibility
Certification
Features
Related Courses
RA Course comparison
Free add on course
Regulatory Course Comparison
This online drugs biologics regulatory affairs course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for pharmaceutical and biopharmaceutical industry.
This comprehensive drugs biologics 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 discovery, development, investigational application, marketing authorization application, handling of different phases of clinical trial, generic approval process, Abbreviated drugs approval process. Hence, the course covers fundamentals to advance learning on drugs, biologics development, regulation, registration and strategic management processes.Â
Most importantly, international drug regulatory affairs course covers comprehensive training all regulatory regions like US, EU, GCC, MENA, Middle East, CIS, African, ASEAN, Japan, Russia, China, India and Rest of the World
Who should attend this course?Â
- Those who are in the regulatory affairs and related department.
- Professionals from drugs, biologics 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-092
Title: Executive PG Certification in International Drug Regulatory Affairs (EPGIDRA)
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.
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
Features of International Drug Regulatory Affairs
- This course covers all aspects of the drug, biologics regulatory affairs in a single course. Hence, user need not to purchase the drugs, 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 strategic planning.
Few of the similar courses
- ASEAN Drug Regulatory Affairs
- Drug Biologic Medical Devices Regulatory Affairs
- 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
Comparison of Regulatory Affairs Courses [www.royed.in]
Course Coverage |
Executive PG Certification in International Drug Regulatory Affairs |
Executive PG Certification in Drug, Biologic, Medical Devices Regulatory Affairs |
PG Certification in Drug Regulatory Affairs |
Drug Regulatory Affairs |
YES |
YES |
YES |
Medical Devices Regulatory Affairs |
NO |
YES |
NO |
Biopharmaceutical Regulatory Affairs |
YES |
YES |
YES |
Regional Regulatory Affairs |
|||
US |
YES |
YES |
Yes |
EU |
YES |
YES |
YES |
GCC |
YES |
YES |
NO |
Middle East |
YES |
YES |
NO |
Japan |
YES |
YES |
NO |
China |
YES |
YES |
NO |
ASEAN |
YES |
YES |
NO |
Africa |
YES |
YES |
NO |
Russia |
YES |
YES |
NO |
LATAM |
YES |
YES |
NO |
Other – ROW |
YES |
YES |
NO |
Free and Add on Courses |
|||
Free Add on course |
1 month certificate course, 1 week certificate course |
1 month certificate course, 1 week certificate course |
NONE |
Free Add on certification course
- This course comes with 2 credit of add on certification course. Hence, participants of PG Certification in Drug, Biologic 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.
Regulatory Affairs Course Comparison
Course Coverage |
Executive PG Certification in International Drug Regulatory Affairs |
Executive Program in Drug Biologic Medical Devices Regulatory Affairs |
PG Certification in Drug Regulatory Affairs |
Drug Regulatory Affairs |
YES |
YES |
YES |
Medical Devices Regulatory Affairs |
NO |
YES |
NO |
Biopharmaceutical Regulatory Affairs |
YES |
YES |
YES |
Regional Regulatory Affairs |
|||
US |
YES |
YES |
Yes |
EU |
YES |
YES |
YES |
GCC |
YES |
YES |
NO |
Middle East |
YES |
YES |
NO |
Japan |
YES |
YES |
NO |
China |
YES |
YES |
NO |
ASEAN |
YES |
YES |
NO |
Africa |
YES |
YES |
NO |
Russia |
YES |
YES |
NO |
LATAM |
YES |
YES |
NO |
Other – ROW |
YES |
YES |
NO |
Free and Add on Courses |
|||
Free Add on course |
1 month certificate course, 1 week certificate course |
1 month certificate course, 1 week certificate course |
NONE |
