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Monthly FDA Guidance and Regulatory News Review - September 2026
This September 2026 regulatory update focuses on FDA’s new guidance on neonatal parenteral nutrition compounding and...
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We are pleased to announce that Shayesteh Fürst-Ladani, will speak about “How much clinical data from medical device studies is enough to support application for CE Certification? ” in the Roundtable organized from 9:00-10:30 am.
Don’t miss Shayesteh and the full line-up of experts convening to discuss the very latest clinical and regulatory updates.
Chair: Ghazaleh Gouya, Priv. Doz Dr. med Cardiologist, Founder of Gouya insights, GPMed Board Member & IFAPP Board Member
Speakers:
‘Design of clinical MD investigations and approvable endpoints’
Dr. Andreas Beust, Chief Scientific Officer, GCP-Service International Ltd. & Co. KG
‘ How much clinical data from Medical Device studies is enough for CE mark?"
Shayesteh Fürst-Ladani, MBA, MSc, GFMD, Senior Vice President SFL, Head of SFL Group
‘Guidance documents"
Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, School of Medicine, Trinity College

Website: https://www.icpm2022.gr/
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Oct 21, 2026 Veristat Blog
This September 2026 regulatory update focuses on FDA’s new guidance on neonatal parenteral nutrition compounding and...
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Sep 21, 2026 Veristat Blog
This August 2026 regulatory update focuses on the FDA finalizing three guidances addressing formal sponsor meetings,...