Leitfaden zur Zulassung eines Produktes mit Fertigspritze gemäß der EU MDR | Kombinationsprodukte in der EU (nach Art. 117 MDR)
Im Rahmen der Konferenz zu Kombinationsprodukten in der EU (nach Art. 117 MDR) am 11./12. November 2024 präsentierte Dr. Thomas Römer von Boehringer Ingelheim wertvolle Einblicke in die praktische Umsetzung und die Herausforderungen bei der Zulassung von Fertigspritzen gemäß EU-MDR.
Leitfaden zur Zulassung eines Produktes mit Fertigspritze gemäß der EU MDR. Erfahrungen und Herausforderungen
Die Einreichung einer „Notified Body Opinion" bei der Benannten Stelle erfordert eine sorgfältige Planung. In dem Vortrag werden zunächst Erfahrungen aus einem konkreten Projekt aus der Sicht des Antragstellers vorgestellt. Dabei geht es um die Anforderungen hinsichtlich des kompletten Einreichungspakets für eine Fertigspritze sowie dessen Bewertungsprozess durch die Benannte Stelle und die Behörden. Dabei wird klar: Es gibt nach wie vor Herausforderungen und Spannungsfelder beim Artikel-117-Prozess. Gemeinsam mit dem Dachverband der Benannten Stellen (Team NB) und dem europäischen Dachverband der forschenden Pharmaunternehmen (EFPIA) haben wir deshalb an Lösungen zu diesen Problemen gearbeitet.
- Planung einer „Notified Body Opinion"- Einreichung bei der Benannten Stelle
- Erfahrungen mit den Anforderungen des Einreichungspakets
- Erfahrungen bei der Interaktion mit den Benannten Stellen während des Bewertungsprozesses
- Herausforderungen beim Artikel-117-Prozesses - Austausch mit dem Dachverband der Benannten Stellen (Team NB)
Dauer: ca. 45 Minuten
Vortragssprache: Deutsch | Folien: z.T. Englisch
Referent: Dr. Thomas Römer
Für etwaige Fragen stehen wir Ihnen jederzeit zur Verfügung. Wir freuen uns auf Sie.
Hinweis zum Kontingentabruf: Bei Buchung dieses hier beschriebenen Webinars wird je Teilnehmer eine Einheit abgezogen.
- Dr. Thomas Römer
Boehringer Ingelheim GmbH & Co. KG
E-Learning | Streaming im MP4 Format
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Price: 2,500.- € per contingent plus VAT.