To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago, BPOG’s Regulatory Interaction team has been developed to help phorums and workstreams to connect with regulators in the most constructive way. Over this period they have formed a strong team who have devised the best ways making sure that our teams knock on the right doors at the right time with the right message. In this article, we will describe how the Regulatory Interaction team works and the benefits it brings to all BPOG members.
The 30 regulatory experts from over 20 biopharmaceutical companies that comprise the team, bring extensive regulatory expertise and a wealth of experience gained from not only their own companies but from their extended networks and their connections to regulators and other industry groups.
Regulatory Interaction has been described as ‘helping with opening doors’ with regulatory authorities/agencies. But what might this mean in practice?
Is the door already open?