Outsourcing-Pharma spoke to some of the industry’s leading experts to get their opinion on the matter, and it seemed that for most, a change is welcome.
We asked just one question: “What should be the key focus for regulatory reform, and do you think changes in the pipeline are for the better?”
But with firms from different ends of the pharmaceutical spectrum, opinions on exactly what should be changed were a mixed bag.
Clinipace’s senior director and head of regulatory affairs Franck Wierckx thinks we will see a big impact in the field of pharmacovigilance when planned changes in regulations take effect.
Karel Bastiaanssen CEO and co-founder of Phrisma said there is a need for focus on data management.
Meanwhile CEO and founder of regulatory advisor the Weinberg Group, Matthew Weinberg, told us advancements in personalisation will pose the biggest challenge for the US FDA (Food and Drug Administration) in particular.
And Carolyn Finkle, Catalent’s VP of global regulatory consulting, foresees harmonisation in technology assessment as the way forward.