InstructorRoyed Training
TypeOnline Course
Price$180 USD / 7500 INR
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drug regulatory affairs 1 week program

Introduction

Course Type

Course Duration

Eligibility

Certification

Course Code: RYD-016

Course Objectives: The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan.

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.

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/Beginners, Those who want to make a career in drug regulatory department

Online distance learning course. Course can be accessed online across anywhere 24×7.

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

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