Regulatory Affairs for other Disciplines - 5 part-series in total 5 h
The webinar is designed for colleagues from other departments outside of regulatory affairs in pharmaceutical companies, API manufacturers and service providers. It is intended to provide an overview of the requirements for marketing authorisation and the corresponding changes in Europe, whereby differences to the US system are also explained. With the contents conveyed, the specialist departments working on marketing authorisation (with a focus on the Q departments) should be in a better position to anticipate specific marketing authorisation requirements and to take these into account when preparing marketing authorisation-relevant documents.
The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.
Part 1 | Marketing Authorisations for Pharmaceuticals - legal requirements (EU/US)
Duration about 85 minutes
- Relevant authorities in Europe
- Relevant authorities USA
- European requirements / EMA and EU Commission
- US requirements /FDA
- International harmonisation / ICH
- Role of pharmacopoeias (EP/USP)
Part 2 | National authorisation procedures, EU and international authorisation procedures
Duration about 100 minutes
- Types of approval EU
- Full Application
- Generic Application
- Hybrid Application
- Well-established use
- Traditional registration
- Types of registration USA
- NDA
- ANDA
- BLA
- National registration in Europe
- Decentralised procedures (DCP/MRP)
- Centralised approval in the EU
- Approval procedure in the USA
- Special procedures
- International recognition of marketing authorisation decisions
Part 3 | Marketing authorisation application including marketing authorisation dossier, structure and contents of the CTD/eCTD
Duration about 60 minutes
- Modules 1, 4 and 5
- Module 2 and 3 - CMC data
- Module 2.3 in USA
Part 4 | API dossiers (e.g. ASMF, CEP, DMF)
Duration about 45 minutes
- Active substance dossiers in Europe (CEP/ASMF)
- Active substance dossier in the USA
Part 5 | Variation requirements for the finished medicinal product
Duration about 60 minutes
- Life cycle concepts for marketing authorisations
- ICH Q12
- Variations Regulation in Europe
- Classification of changes (Type IA and IB Notifications, Type II Variations, Line extension)
- Procedure for variation application depending on the procedures (national, decentralised, centralised)
- Changes in USA
Duration of the recording: approx. 325 minutes in total
Lecture language: English | Slides: English
...your speaker Dr. Markus Veit...
Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.
Note on quota call-off: When booking the entire webinar series, five units per participantwill be deducted.
For team training, please contact us.
- Dr. Markus Veit
ALPHATOPICS GmbH
E-Learning | Streaming in MP4 format (EN)
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.