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
DMF & SMF
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
Content
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
Content
USFDA regulation
510(k) pre-market notification
Pre-market approval
Section 3
Content
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
