Scientific Advice in the EU and US: Practical Experience and Rules of the Game on Both Sides of the Atlantic

by Dr. Gabriele Dallmann

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Drug development is a long-term, costly and high-risk commitment, becoming increasingly complex and global. What brings at the end the product successfully and fast to approval and to market at the price level envisaged by the company?

It is a holistic and well-integrated drug development and regulatory strategy, which had been put in place from very early on. An essential element is the interaction with agencies, i.e., a series of events planned globally and for a long-term period, at which the development program is exposed to agencies properly selected for the specific purpose in question to get their feedback and to enable the company to proceed with their planned next steps of development.

In her publication, Gabriele Dallmann provides practical hands-on advice on the scientific advice procedures in the EU and US and on how to use scientific advice in a value creating regulatory strategy.