TypeOnline Course
Student Enrolled3
(1 ratings)
Price$180 / Rs. 8500
Buy NowBook Now

Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

Course Application Form

Introduction

Course Duration

Course Code: KPE-C-054

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

Certificate will be provided at the end of the successful completion of the course

7 Days / 1 Week 

Section 1R&D Process and Drug Discovery
Section 2Investigational New Drug Application
Section 3New Drug Application
Section 4Introduction to the Generic Drugs and generic drug approval process
Section 5Review on Drug Discovery and Development
Section 6USFDA Expedited Program
Section 7GDUFA and PDUFA
Section 8Practical Training on INDA and ANDA filing
Section 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Section 10Generic Drug Marketing Strategies
Section 11Exploratory IND Vs. Traditional IND
Section 12Patents Vs. exclusivity 
Section 13Orphan Drug & Orphan Drug Act
Section 14Advance Learning on 505B2 Pathway
Section 15Final Examination