Stephan Hütter
CENCORA PharmaLex GmbH, Mannheim, GERMANY
Director Global Program Management / Regional Lead LATAM
More information please click here.
01/10/2026
01/10/2026
9:00-13:00 CET
online
online
Event - 690€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: Introduction to EU Marketing Authorisation
, online
Your booking advantage: You book the seminar at the regular price and add the e-learning. The price of the e-learning is reduced by 100 € to
290,00 €
Event - 690€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: Introduction to EU Marketing Authorisation
, online
Your booking advantage: You book the seminar at the regular price and add the e-learning. The price of the e-learning is reduced by 100 € to
290,00 €
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Overview of RA outsourcing & vendor oversight: risk-based vendor selection, governance and compliance controls. Practical and compact in just half a day
This half-day seminar provides a practical introduction to outsourcing and vendor oversight in regulatory affairs. Based on a structured, step-by-step approach, you learn how to decide when outsourcing makes sense, how to select and qualify vendors in a risk-based way, and how to set up governance, communication and performance management for outsourced RA activities.
The seminar also addresses how to maintain effective oversight throughout the collaboration - including monitoring parameters, change control, and regular vendor reviews (up to audit and requalification).
By the end, you will have a clear framework and concrete steps to strengthen compliance and reliability in day-to-day vendor management.
Introduction and technical warm-up
Stephan Hütter
Stephan Hütter
Coffee break
Stephan Hütter
Stephan Hütter
Stephan Hütter
End
Do you lack basic marketing authorisation expertise? Then, we would recommend the e-Learning 'Introduction to EU Marketing Authorisation'.
This will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Simply register for the seminar clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€290 + local VAT rather than €390 + local VAT).
Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional online trainings.
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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