A Comprehensive Review of Regulatory Procedures for Investigational New Drugs (INDs) in the US
As drug development becomes a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information?
This course will focus on commercial (standard) INDs for drug and biologic products; the regulatory process for medical devices or multisourced (generic) products will not be addressed in detail.
What you will learn
- Regulation of drugs and biologics in the US: The basics
- Overview of the FDA
- US Regulatory requirements for drug development and approval
- Interactions with FDA
- The IND - A general introduction
- The IND - In detail
- IND Amendments and maintenance
- Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
Who should attend?
This course will also enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc.
DIA also welcomes attendance by regulatory agency staff members.
At the conclusion of this course, participants will be able to:
- Define the key principles and processes used by the US Food and Drug Administration (FDA) in regulatory submission and maintenance of the IND
- Define official regulatory policies and other issues pertinent to a successful US regulatory strategy
- Recognise FDA oversight and processes during the post-approval phase
- Interact appropriately with the FDA during all phases of drug development
Participants will complete a knowledge check at the end of the course to ensure learning objectives are attained.
Plan Your Team's Professional Development
Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:
- Cost Effectiveness
For more information please contact EMEA@DIAglobal.org