InstructorRoyed Training
TypeOnline Course
Price$290 USD / 15950 INR
Buy NowBook Now
Loading
free resources at royed training
Loading
drug regulatory affairs online course

Hen

Introduction

Course Type

Course Duration

Eligibility

Certification

About Drug Regulatory Affairs

Similar Courses

online drug regulatory affairs training

This online drug regulatory affairs course provides training on regulation, registration process and strategic planning for pharmaceuticals. This 1 week short online course trains Drug Regulatory Affairs professionals on fundamental aspects of drug discovery, development related regulations. In addition, the course provides practical knowledge. Hence, this short drug regulatory affairs short certification course helps how regulatory affairs department works in pharmaceutical company. Therefore, it helps users to understand the key responsibilities and job functions.

In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. For example, course covers important topics like 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. Hence, this course covers comprehensive topics to develop the fundamental competency on drug regulatory affairs.

Course Code: RYD-016

Course Title: Competency Development Program in Drug Regulatory Affairs

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.

This is online self paced learning course. Therefore, this course is accessible 24×7 from anywhere.

7 Days / 1 Week 

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

What Drug Regulatory Affairs Department in pharmaceutical company?

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities’ attitudes and requirements etc. have a great influence on the drug development process and the success of it. Hence, regulatory affairs professionals deal with these aspects.

Role of Drug Regulatory Affairs Department

The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. For instance, internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Most importantly, they are the key interface between the company and the regulatory authorities. Moreover, Regulatory Affairs Professionals are involved in product development from the beginning.

What Regulatory Affairs Manager do?

Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Moreover, they coordinates inspection of the organization and contract facilities, and also develops procedures to ensure regulatory compliance.

Section 1Fundamental of Drug Discovery Regulations
Lecture 1R&D Process & Introduction to drug discovery 
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug 
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Complete Response Letter | Key understanding | Management and Action Plan
Lecture 7Handling of orange book
Lecture 8USFDA expedited programs
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Patents Vs. exclusivity 
Lecture 13Orphan Drug Designation 
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls 
Lecture 16Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 17Review on Drug Discovery and Development 
Section 2Clinical Trial
Lecture 18Clinical Trials Terminologies 
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21FDA Forms and How to fill the resources
Lecture 22Strategic Discussion: PreIND, EOP1, EOP2 - What to expect
Section 3Final Examination