DUBLIN--(BUSINESS WIRE)--The "The FDA Drug Approval Process" conference has been added to ResearchAndMarkets.com's offering.
This course is designed to help you gain a better understanding of the US drug approval process. You will gain a practical insight into FDA requirements for submission of NDAs, ANDAs and 505(b)(2). It will also cover the organisation and structure of the FDA and review processes, as well as discuss recent changes.
The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.
Benefits of attending:
- Gain an overview of FDA drug development regulatory requirements
- Comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
- Discuss recent changes and developments
- Improve your communication and interactions with the FDA
Agenda
Programme Day One
An overview of the US FDA Drug development regulatory requirements for FDA
- Overview of INDs
- Data requirements for drug substance and drug product
- Pre-clinical testing and clinical testing
- The different phases of development
Drug development regulatory requirements for FDA (continued)
Overview of the IND application and the data requirements
- IND structure
- Submission procedure
- IND review
- FDA actions
Maintenance of INDs
- Structure and content of STED
- Technical File vs Design Dossier
Identifying recent changes
- Examining accelerated review and breakthrough status
- Paediatric legislation
- Financial disclosure
- Clinical trial transparency
- Exclusivity and patent declaration
Workshop: Understanding FDA meetings
- An overview of the different types of FDA meetings
- Create a best practice guide for meeting preparation and attendance
Programme Day Two
Identifying the NDA types and categories
- What is a full NDA?
- 505(b)(2) applications
- CTD requirements
- FDA approach to CTD format
- Review approach
- US regional requirements
Review of ANDA/NDA
Understanding ANDA classification
- Examining paragraph I-IV
- Overview of GDUFA
US change control - amendments
- NDA/ANDA amendments
- SUPAC/BACPAC guidance
- Annual reports/CBE and PAS applications
- NDA annual report requirements
Obtaining information from the FDA
- Access to Federal Register
- FOIA
- FDA homepage
Final discussion and review of day
For more information about this conference visit https://www.researchandmarkets.com/research/qxdkmb/2day_course_the?w=4
