Maintenance and sustainment of human medicinal product approvals
Webcode 25062610
Siniša Belina
MAIN5 GmbH & Co. KGaA, Frankfurt, GERMANY
Principal Consultant
Siniša Belina is an experienced consultant with history of working in the pharmaceutical and IT industry, with particular skills in pharmaceutics, quality management, regulatory affairs, and document management. He applies this detailed knowledge to the areas of business process analysis, optimisation of software solutions and their implementation. He started his professional career at Pliva (now part of the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. Later he joined KRKA's Regulatory Affairs Department, after which he moved to Amplexor (now ArisGlobal) in 2008. Since 2022 he works as a consultant with MAIN5. Siniša received his Master of Science degree in Pharmacy from Zagreb University.
More information please click here.
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, Oss, THE NETHERLANDS
Regulatory Consultant
More information please click here.
Dr. William Shang
Kenvue, Part of the Johnson & Johnson Family of Companies, Neuss, GERMANY
Director Regulatory Affairs Central Europe
More information please click here.
04/06/2025
04/06/2025
from 09:00 - 17:00
You may dial-in 30 minutes before
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: EU Variation System and Procedures
, online
Simply register for the seminar and receive a €100 discount on the e-learning (€390 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
390,00 €
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: EU Variation System and Procedures
, online
Simply register for the seminar and receive a €100 discount on the e-learning (€390 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
390,00 €
Dr. Rebekka Bitsch
Conference Manager
+49 6221 500-565
r.bitsch@forum-institut.de
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.
This seminar provides a comprehensive overview of all maintenance activities in the lifecycle of a medicinal product.
Participants will receive thorough training on the main regulatory duties, from dossier update and variations to PV activities, through to labelling maintenance duties. All in a single seminar.
Time and deadline management, as well as internal company interactions and coordination will be covered, which makes the seminar interesting for professionals from the various departments involved in the product lifecycle.
Welcome, introduction and technical check
Dr. William Shang
Ingrid Prieschl
Coffee break
Siniša Belina
Lunch break
Dr. William Shang
Dr. William Shang
Coffee break
Ingrid Prieschl
Final questions and discussion
End of seminar
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.
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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.
Overall impression: 100 % of the participants' feedback was very good or good (December 2024)
Practical benefit: 84 % of the participants' feedback was very good or good (December 2024)
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Very well organised training
informative, based on practice,clear language
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covered all important topics plusupcoming changes
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