by Denise Strömquist | Mar 26, 2021 | Event, Featured, Insights, News
During the DIA Europe meeting 15-19 of March, NDA consultants conducted a session on value communication for new products or therapies. Chairing the session was Steffen Thirstrup from NDA Advisory Board, accompanied by Carole Longson, Association of the British...
by Denise Strömquist | Nov 18, 2020 | Featured, News, Staff Spotlight
Steffen is one of NDA Groups’s experts on Oral Explanations. Prior to joining NDA seven years ago, Steffen spent nine years as the Chief Medical Officer and Head of Division at the Danish Medicines Agency. During five of those he also acted as the Danish...
by Lisa Peluso | Sep 27, 2020 | Featured, Insights
By Lisa Peluso While we work with global companies to strategize and execute successful engagements with regulators at critical junctures such as Oral Explanations and FDA Advisory Committee meetings, excellent communications are the backbone of streamlined, efficient...
by Laurie Smaldone | Sep 18, 2020 | Featured, Insights
“Of a good beginning cometh a good end.” Chinese Proverb By Laurie Smaldone Alsup, MD It’s common knowledge that communicating early and regularly with the FDA is critical to regulatory success. Getting the review division’s opinions on study design and plans,...
by Denise Strömquist | Aug 31, 2020 | Featured, News, Staff Spotlight
Frank is a pulmonary/critical care physician with over 25 years of experience in the pharmaceutical industry. He has worked across numerous therapeutic areas including allergy, respiratory, cardiovascular, endocrinology and metabolism, and has led several NDA and MAA...
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...
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