TypeOnline Course
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Price$390 / Rs. 19500
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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 USFDA regulatory affairs
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers

Course flow:

Section 1Drug Regulation Fundamentals
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Abbreviated New Drug Application (ANDA)
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10USFDA expedited Program
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity 
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug & Orphan Drug Act
Section 2Clinical Trial
Lecture 18Clinical Trial Detailed Study (Topic - 1-11)
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Section 3Regulatory Strategies
Lecture 22Regulatory Strategies in different phases of Clinical Trial
Lecture 23Advance study on Para IV Filing
Lecture 24Evergreening - Patent Life Extension Strategies
Lecture 25LOE Strategies for Innovator Brands with case study
Lecture 26Pediatric Exclusivity
Lecture 27Drug Repurposing
Lecture 28REMS Strategic Planning 
Lecture 29Compulsory Licesning
Lecture 30Para IV Notices
Section 4USFDA warning Letter
Lecture 31CAPA
Lecture 32USFDA Warning Letter
Lecture 33Handling of warning letter
Section 5Drug Registration Dossier
Lecture 34CTD
Lecture 35Introduction to Electronic Common Technical Document (ECTD)
Lecture 36Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 37Advance Practical Training on Dossier Preparation
Lecture 38Modules on Stability Study 1
Lecture 39Stability Study Test 
Lecture 40Module on Interchangeability 
Lecture 41Stability Testing of API 
Lecture 42Stability Testing of Finished Pharmaceutical Products
Lecture 43Review Test on Stability Testing 
Lecture 44 Black Box Warning
Lecture 45DMF & SMF
Lecture 46Site Master File
Lecture 47Practical Training on preparing DMF and SMF
Section 6Medical Device Regulation
Lecture 48Overall Understanding of US Medical Devices
Lecture 49Definition of Medical Devices
Lecture 50Classification of Medical Devices
Lecture 51Examples of Medical Devices
Lecture 52Review
Lecture 53510k - Pre-market Notification
Lecture 54Premarket notification (510(k)) submission
Lecture 55FDA 510(k) Step By Step - Decision Making process
Lecture 56FDA decision making process for different classes of 510k applications
Lecture 57Review
Lecture 58Premarket approval (PMA) application
Lecture 59Differences between 510k VS. PMA
Lecture 60Is PMA required for unclassified devices?
Lecture 61Data Requirements for A Premarket Approval (PMA) application
Lecture 62PMA Quality System - Design Controls
Lecture 63PMA Labeling
Lecture 64Investigational Device Exemption
Lecture 65PMA Postapproval Requirements
Lecture 66Postmarket Surveillance Studies
Lecture 67PMA Supplements and Amendments
Lecture 68Expedited review of devices
Lecture 69Expiration Dating
Lecture 70Device Master Files
Lecture 71Unapproved use of Medical Devices 
Lecture 72Marketing, Advertising and Promotion of Medical Devices
Lecture 73FDA 513(g) Submission
Lecture 74De Novo Petition - Medical Devices Regulation
Lecture 75Humanitarian Device Exemption (HDE)
Section 7FDA Forms and How to fill the resources