TypeOnline Course
Price$490 / Rs. 24500
Buy NowBook Now
course on usfda regulation

Course Title: KPE’s Certificate Program in USFDA regulation of pharmaceuticals, biotech and medical devices regulation

Course Objective: The objective of this course is to impart knowledge and practical understanding about the Drug, biotech and medical devices Regulatory Affairs and approval process in US.

Features of the Course:

1. Orientation to practical understanding USFDA Regulatory process of pharmaceuticals, medical devices and biotech products.

2. Simulation to real life Strategic planning in US market

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

Duration: 1 Month



Course Description

This online course utilizes interactive learning tools to guide each participant through to understand of the USFDA regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on European regulatory affairs
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers

Course flow:

USFDA Pharmaceuticals / Biotech Regulation

R&D Process & Introduction to drug discovery

Investigational New Drug Application (INDA)

New Drug Application (NDA)

Basic concept and understanding of the Generic Drug

DRA working in DRA department

Abbreviated New Drug Application (ANDA)


Generic Drug User Fees Act  (GDUFA)

Prescription Drug User Fees Act (PDUFA) 


Handling of orange book

Priority Accelerated Review


Practical Training on INDA and ANDA filing

Promotion Advertisement Regulations (Practical)


Dossier Reparation

Introduction to Common Technical Document (CTD)

Advance Practical Training on Dossier Preparation focusing on drug registration in export countries

Assignment and real life dossier preparation – step by step guideline


Overall understanding of dossier compilation process

Modules on Stability Study

Test on Stability Test

Module on Interchangeability


Stability Testing of API

Stability Testing of Finished Pharmaceutical Products


Review Test on Stability Testing


E-CTD – Basics


Regulatory Strategies in different phases of Clinical Trial



Drug Master File

Site Master File

Practical Training on preparing DMF and SMF


Generic Drug Marketing Strategies

Advance study on Para IV Filing

Evergreening – Patent Life Extension Strategies


Advance understanding on  Biotech & Biosimilar Drugs and Guidelines

Introduction to Biosimilar

Biosimilar Approval process


Biological Licensing Application (BLA)

Vaccine development and approval Process


USFDA Warning Letter – Handling of warning letter



Formulation, Quality and Regulatory Manual for handling CAPA

Introduction to CAPA


Global Pharma Industry


Drug Registration in European Country – Understanding differences with the USFDA

Centralized Procedure

Decentralized Procedure

Mutual Recognition Procedure

Dossier Preparation for European submission


US Medical Devices Regulation


Section 1



US Medical Devies Market – Introduction & SWOT  Analysis

Definition of Medical Devices

Different Classes of Medical Devices and their working principal

USFDA – Classification for Medical Devices based on risk

USFDA – CDRH Overview

Medical Devices Regulation in US Introduction to Medical Devices


Section 2



USFDA regulation

510(k) pre-market notification

Pre-market approval


Section 3


Details understanding of Pre Market Approval Process with flow chart

510k VS. PMA

Investigational Device Exemption


Section 4

De Novo Petition – Medical Devices Regulation


Section 5

Investigational Device Exemption (IDE)

Device Clinical Research

Early/Expanded Access of Medical Devices

Trials of Medical Devices


Humanitarian Device Exemption (HDE)


Section 6: Labeling Requirement for Medical Devices


Section 7: Marketing, Advertising and Promotion of Medical Devices


Section 8: Unapproved use of Medical Devices


Section 9: EU Regulation of medical devices and differences with USFDA regulation


Section 9A : EU regulation of Medical Devices Session 1  

Medical Devices: EU Directives, Classification and Guidance, CE Marking.


Section 9B: Quality Management System (QMS) for medical devices company

ISO Certification for Medical Devices company

CE Marking for Medical Devices company

Medical Device regulatory professionals responsibility