FDA Submissions: Make the Application Process Work for You

Preparation of FDA Submissions and Communicating with the FDA course gives you the skills and confidence necessary to apply for FDA certification.

The course covers INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Crucially, it also covers how to structure meetings with the FDA, drawing on the real-world experience of our instructors. This course is designed to make you feel confident and able to get the information you need in these review sessions.

Designed for pharmaceutical professionals who prepare FDA submissions the course offered by CfPIE on FDA Submissions and Communicating with the FDA, is also useful for Project Managers and anyone involved in quality testing, regulation and related manufacturing roles. As the FDA continues to report high rates of non-compliance from pharmaceutical firms, the need for FDA certification training has only increased.

Costly delays from laboratory practices that do not meet FDA standards result in both lost revenue, and high fines from the FDA itself. Non-compliance fines can reach a total of $10,000 per day until the issue is resolved, illustrating the importance of clear initial communication and excellent initial applications and reporting. A further issue stems from belated results reporting, to which an FDA tracker reported a disclosure rate of only 59.5%. This stat can only mean that attention to these reporting concerns will increase over the next few years until compliance hits an acceptable rate.

To become an in-demand FDA Submissions professional, register for our two-day course, approved by the Regulatory Affairs Professional Society (RAPS).

Source:

https://www.outsourcing-pharma.com/Article/2018/10/08/FDA-guidance-on-clinical-trial-data-disclosure-falls-short-while-noncompliance-remains-high