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
Who should attend?
This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.more
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