by Michael Piperno | Aug 7, 2020 | Featured, Insights
8 Tips to Set Your Team Up for Success By Michael Piperno There is perhaps no regulatory event as intense as an FDA Advisory Committee meeting. The stakes are high, and the applicant team has spent the last six months getting ready to deliver and defend a cohesive and...
by Lisa Peluso | Jul 27, 2020 | Featured, Insights
By Lisa Peluso Public speaking has become, well — less public. It’s been relegated to our home offices, with scripted presentations, glossy slides and even “appearance touch-up” options on our video conference systems. These are helpful, almost comforting crutches and...
by Lisa Peluso | Jul 15, 2020 | Featured, Insights, News
By Lisa Peluso If you logged in for the first product approval-related virtual FDA Advisory Committee meeting on July 14th, you experienced a rough start. Riddled with long silences (people failing to take themselves off mute while speaking), poor audio quality and...
by Lisa Peluso | Apr 15, 2020 | Featured, Insights
By Lisa Peluso In the face of a pandemic, remote working is now a requirement. Facilitating group meetings can be challenging when face-to-face, but what happens when all you have is a voice and – if you’re lucky – a shared screen? Engaging successfully is more than...
by Steffen Thirstrup | Jan 20, 2020 | Featured, Insights
By Steffen Thirstrup Having the possibility to engage face-to-face with EU regulators is the ideal situation to help with authorisation of your product. However, most interactions in the EU are in writing and very few sponsors have the opportunity for a meeting with...
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