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Stock impact report

FDA (Food and Drug Administration) Drug Approval Process Training Course: Comprehensive Programme Covering Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (LIVE ONLINE EVENT/O...

Catalent, Inc. (CTLT) 
Last catalent, inc. earnings: 2/3 07:30 am Check Earnings Report
US:NYSE Investor Relations: investor.catalent.com
Company Research Source: Yahoo! Finance
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. 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 com Show less Read more
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