The FDA Drug Approval Process
The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.
The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight 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.
There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.
Benefits of attending:
- Review the latest FDA regulatory requirements for drug development
- Understand FDA regulatory strategic needs
- Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
- Discuss recent changes and developments with an industry expert and Improve your communication and interactions with the FDA
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Reviews by course attendees
Average rating 4.4
Very good webinar I am glad I was able to attend.
Good webinar focused on various stages of the FDA drug/device approval process.
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
A good, detailed process of FDA drug approval process