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2026-02-19_Unlocking the Potential of Regulatory Pathways for Global Health Products - Using the EMA "Article 58" Procedure - A Case Study
IQVIA Innovation Park
2400 Ellis Road
Durham, NC 27703
US

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Thursday, February 19, 2026, 5:30 PM - 8:00 PM EST
Category: Events

Title: "Unlocking the Potential of Regulatory Pathways for Global Health Products - Using the EMA "Article 58" Procedure - A Case Study"

 

Speaker: Susanne Wilhelm

 
Location:  IQVIA, 2400 Ellis Rd. Durham, NC 27703 and via ZOOM (link in confirmation email)
 
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Biosketch: 

"Susanne has a broad background in global regulatory affairs with over 20 years of experience in the pharmaceutical industry. Her career spans both major pharmaceutical corporations and small Biotechs, where she has successfully navigated the ever-evolving regulatory landscapes to define and execute strategies for numerous drug and device applications, resulting in multiple agency approvals.

Beyond traditional pathways, her expertise includes specialized filing procedures, such as the EMA’s Article 58 (now EU-M4all).

Susanne holds a BS and MS in Biology from Rheinische-Friedrich-Wilhelms University Bonn, Germany. Outside of her professional life, she enjoys traveling and reading. She is also an avid hiker with the long-term goal of someday hiking the Camino de Santiago."


Contact: [email protected]