SoHO-Verordnung: Was kommt auf die pharmazeutische Industrie zu?
Die neue Verordnung (EU) 2024/1938 vom 13. Juni 2024 über Qualitäts- und Sicherheitsstandards für Substanzen menschlichen Ursprungs („Substances of Human Origin“ = „SoHO“), die zur Verwendung am Menschen bestimmt sind, trat am 6. August 2024 in Kraft.
SoHO ist jede Substanz, die aus dem menschlichen Körper gewonnen wird sowie Präparate, die aus der Verarbeitung von SoHO hervorgehen. Ei- und Samenzellen, Blut, sowie Zellen und Gewebe werden von der neuen Verordnung erfasst. Die neue Verordnung soll den Schutz von Spender*innen und Empfänger*innen von SoHO und die Versorgung mit kritischen SoHO sicherstellen. Sie gilt EU-weit und ersetzt zukünftig die Blut- und Geweberichtlinie.
Diese Themen werden u.a. im Webinar vorgestellt:
- Hintergrund und Ziele der Verordnung
- Anwendungsbereich und Definitionen
- Klinische Studien und Zulassung von SoHO
- Vigilanzaspekte
- Betriebsstätten
- Delegierte Rechtsakte und Übergangsbestimmungen
Dauer: ca. 90 Minuten
Vortragssprache: Deutsch | Folien: z.T. Englisch
Referentin: Dr. Xenia Boergen
Sollten Sie am Tag des Live-Webinars verhindert sein, so teilen Sie uns das gern bereits bei Anmeldung mit. Wir bieten Ihnen die Möglichkeit, das Webinar dann im Nachhinein individuell zu streamen.
Hinweis zum Kontingentabruf: Bei Buchung dieses hier beschriebenen Webinars wird je Teilnehmer eine Einheit abgezogen.
Für Teamschulungen sprechen Sie uns bitte an.
- Dr. Xenia Boergen
Boergen Rechtsanwaltskanzlei | Boergen Recht & Patente
Goto Webinar - Virtuelle Konferenzplattform
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
Consent to photographs and film recordings as well as their publication: We would like to point out that photographs and film recordings are taken during our events by persons or service providers commissioned and authorised by us for the documentation of our events (legal basis Art. 6 para. 1 lit. f DSGVO). The recordings serve our public relations work as well as the use, publication and distribution in print, digital and online media, such as newsletters, websites, brochures, flyers and social networks. In this context, it is pointed out in particular that photos and videos on the internet can be accessed by any person. It cannot be ruled out that such persons will continue to use the photos/videos or pass them on to other persons. By registering for and participating in the event, you agree that the organiser is permitted to publish photos, audio and/or film contributions taken at the event without restriction, including for advertising purposes, across all media without permission or remuneration. You have the right to revoke this consent at any time. The revocation of consent does not affect the lawfulness of the processing carried out on the basis of the consent until the revocation. This means that consent can be revoked with effect for the future. We will then immediately remove your photo/video from our website. In this case, please send your revocation to info(at)alphatopivs.de, stating the event.
Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
You are interested in a live event but don't have time on the scheduled day of the live webinar?
Then simply ignore the reminder emails about the live event. Our webinar platform will register that you were not present. As soon as the webinar has taken place, you will automatically receive an email from us a few hours later with your personal link to stream the webinar. You can then watch the webinar - individually - whenever your schedule allows. If you have any questions about the content, you are welcome to send them later to fragen@alphatopics(dot)de.
Note on contingent retrieval:
When booking via your company contingent, please note the separate note in the description of the webinar as to how many parts will be deducted from your contingent for the selected webinar, or webinar series.
Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.