Praxiswissen zur neuen Variation Regulation und Classification Guideline
Nachdem die aktualisierte EU Variation Regulation 1234/2008 bereits seit 1. Januar 2025 in Kraft ist und Neuerungen wie das Annual Update für Type IA variations oder das verpflichtende Worksharing für Typ IB und Typ II variations mit sich gebracht hat, gelten in Kürze die neuen Regelungen zur Klassifizierung von Änderungstatbeständen.
Ab 15. Januar 2026 dürfen Variations nur noch nach der aktualisierten Version der “Guideline on the details of the various categories of variation, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, and on the documentation to be submitted pursuant to those procedures”, kurz “Variation Classification Guideline”, eingereicht werden.
In unserem Webinar stellen wir Ihnen die Änderungen vor, welche sich durch die Aktualisierung der beiden Guidance-Dokumente ergeben haben. Unser Schwerpunkt liegt hierbei auf operativen Themen wie die strategische Planung und praktische Durchführung von Annual Updates, (Super-)groupings und Worksharings. Dabei geben wir Ihnen wertvolle Tipps und Empfehlungen aus der Praxis, wie Sie Ihr Änderungsmanagement effizient gestalten.
Die Inhalte in der Übersicht:
Revised Variation Regulation
- Geschichte; Überblick, Allgemeines
- Type IA variations
- Annual update
- Immediate notification of Type IAIN
- Super-grouping
- Type IB and Type II variations
- Single variation
- Grouping
- Worksharing
- Vor- und Nachteile von (Super-)grouping und Worksharing, Praktische Tipps
- PACMP
Revised Variation Classification Guidelines
- Übersicht und allgemeine Themen
- Details der wichtigsten Änderungen
Vortragssprache: Deutsch (Folien z. T. Englisch)
Dauer: 3x ca. 90 Minuten
Referent: Dr. Christine Roser
Hinweis zum Kontingentabruf: Bei Buchung dieser Webinar-Reihe werden je Teilnehmer drei Einheiten abgezogen.
Speziell für Gruppen – Ihre Vorteile auf einen Blick
- Attraktive Spezialpreise oder Rabatte für ganze Teams oder kleine Gruppen.
- Auf Anfrage bieten wir maßgeschneiderte Inhouse-Angebote, die optimal auf die Bedürfnisse Ihrer Abteilung oder Ihres Unternehmens abgestimmt sind.
- Streaming+ Möglichkeit dazubuchen: Nutzen Sie unser flexibles Streaming+ Format, das Ihnen zusätzlich eine interaktive Live Q&A-Session mit dem Referenten ermöglicht, um Ihre Fragen direkt mit dem Experten zu klären.
Kontaktieren Sie uns gerne per E-Mail an info(at)alphatopics.de oder telefonisch – wir freuen uns auf Ihre Anfrage.
- Dr. Christine Roser
TentaConsult Pharma & Med GmbH
E-Learning | Streaming im MP4 Format
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.