A Comprehensive Review of Regulatory Procedures for New Drug Applications (NDAs) / Biologics License Applications (BLAs) in the US
As drug development has become a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information for the marketing application?
This course will focus on marketing applications (NDA/BLA) for drug and biologic products; the regulatory process for medical devices or multisourced (generic) products will not be addressed.
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
- Submitting the NDA in CTD format – What’s unique to FDA
- FDA review of and actions on applications
- Post-approval regulatory requirements for NDAs/BLAs
- US regulatory requirements for advertising and labelling
- Regulatory compliance and FDA Inspections: What to expect after submitting the NDA/BLA
Who should attend?
This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, and drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes.
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 approval
- Define official regulatory policies and other issues pertinent to a successful US regulatory strategy
- Describe the requirements for marketing applications for drugs and biologics, New Drug Application (NDA) and Biologics License Application (BLA) and document preparation
- 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