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
Lecture 22
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3Regulatory Strategies
Lecture 24Regulatory Strategies in different phases of Clinical Trial
Lecture 25Advance study on Para IV Filing
Lecture 26Evergreening - Patent Life Extension Strategies
Lecture 27LOE Strategies for Innovator Brands with case study
Lecture 28Pediatric Exclusivity
Lecture 29Drug Repurposing
Lecture 30REMS Strategic Planning
Lecture 31Compulsory Licesning
Lecture 32Para IV Notices
Section 4USFDA warning Letter
Lecture 33CAPA
Lecture 34USFDA Warning Letter
Lecture 35Handling of warning letter
Section 5Drug Registration Dossier
Lecture 36CTD
Lecture 37Introduction to Electronic Common Technical Document (ECTD)
Lecture 38Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 39Advance Practical Training on Dossier Preparation
Lecture 40Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 41 Black Box Warning
Lecture 42DMF & SMF
Lecture 43Site Master File
Lecture 44Practical Training on preparing DMF and SMF
Section 6Medical Device Regulation
Lecture 45Overall Understanding of US Medical Devices
Lecture 46Definition of Medical Devices
Lecture 47Classification of Medical Devices
Lecture 48Examples of Medical Devices
Lecture 49Review
Lecture 50510k - Pre-market Notification
Lecture 51Premarket notification (510(k)) submission
Lecture 52FDA 510(k) Step By Step - Decision Making process
Lecture 53FDA decision making process for different classes of 510k applications
Lecture 54Review
Lecture 55Premarket approval (PMA) application
Lecture 56Differences between 510k VS. PMA
Lecture 57Is PMA required for unclassified devices?
Lecture 58Data Requirements for A Premarket Approval (PMA) application
Lecture 59PMA Quality System - Design Controls
Lecture 60PMA Labeling
Lecture 61Investigational Device Exemption
Lecture 62PMA Postapproval Requirements
Lecture 63Postmarket Surveillance Studies
Lecture 64PMA Supplements and Amendments
Lecture 65Expedited review of devices
Lecture 66Expiration Dating
Lecture 67Device Master Files
Lecture 68Unapproved use of Medical Devices
Lecture 69Marketing, Advertising and Promotion of Medical Devices
Lecture 70FDA 513(g) Submission
Lecture 71De Novo Petition - Medical Devices Regulation
Lecture 72Humanitarian Device Exemption (HDE)
Section 7FDA Forms and How to fill the resources
