InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$690 USD / 34500 INR.
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international drug regulatory affairs

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. 

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? 

  • 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.

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

 

Section 1Fundamental of Drug Discovery and Development
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Preformulation Study in Drug Development 
Lecture 7Regulatory Requirements for Preformulation Study 
Lecture 8Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Lecture 9Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 10Types and Timing of Non-clinical Studies 
Lecture 11Concept of Exploratory IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Review on Drug Discovery and Development 
Lecture 15Understanding on Clinical Trials  and Clinical Research 
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 21Chemistry, Manufacturing & Controls 
Lecture 22Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 23505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25Authorized Generics: Key Understanding
Lecture 26USFDA expedited programs
Lecture 27Complete Response Letter | Key understanding | Management and Action Plan
Lecture 28Introduction to ICH | Members | Guidelines 
Lecture 29ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 30ICH Q2 : Analytical Validation 
Lecture 31ICH Q3 : Impurities
Lecture 32Rest of ICH Q Family Guidelines
Lecture 33Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets 
Section 2African Drug Regulatory Affairs
Lecture 34African Continent Overview - Brief introduction to course
Lecture 35African Pharma Market
Lecture 36Drug Registration - African medicines regulatory agencies
Lecture 37Basic Export Requirement for African Countries
Lecture 38Export Documentations & Important Concepts
Lecture 39Drug Registration and Regulation in Nigeria
Lecture 40Drug Registration in Algeria
Lecture 41Drug Registration in Ethiopia
Lecture 42Drug Registration in Kenya
Lecture 43Drug Registration in Egypt
Lecture 44Drug Registration in Ghana
Lecture 45Drug Registration in Botswana
Lecture 46Drug Registration and Regulation in Uganda
Lecture 47Drug Registration in Zambia