← All events

Time to market

Samen met HollandBIO

21/11/19


Time to market: when clinical trial time can be decreased, what is the new time critical factor?

To get approval of a new biopharmaceutical drug, much time, effort and costs are spent to gather the necessary clinical trial results. However, in order to obtain regulatory approval also the chemistry, manufacturing and control (CMC) module (Module 3 – The Quality section of the CTD) is of vital importance. What should you consider at what stage during drug development? How to prevent delays in regulatory approval as a result of incomplete CMC sections? On November 21st 2019, Progress- PME will organize an event in collaboration with HollandBIO where multiple speakers will share their lessons learned on gathering the required CMC data.

Save the date! – More information will be announced soon.