Webcode 24122610
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.
11/12/2024
11/12/2024
from 09:00 - 17:00
You may dial-in 30 minutes before
online
online
Veranstaltung - 1,190 € 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 - 1,190 € 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
Ingrid Prieschl, Dr. William Shang
Dr. William Shang
Coffee break
Ingrid Prieschl
Final questions and discussion
End of seminar
Sind Sie bereit, Ihr Wissen im Bereich Arzneimittelzulassung auf die Probe zu stellen? Unser interaktiver Kompetenz-Check bietet Ihnen die perfekte Gelegenheit Ihre Kenntnisse zu testen.
Klicken Sie auf das Bild, um zum Learning Snack zu gelangen.
This e-Learning will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.
Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.
Please register for the seminar "Regulatory Lifecycle Management" by clicking '"Register" or "Buchen". You will receive a €100 discount if you also book the e-learning (you will be billed €390 + local VAT rather than €490 + local VAT).
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.
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
Dieses Seminar gibt Ihnen Tipps zur besseren Verfahrensbegleitung im MRP und DCP und zum Lifecycle-Management in Europa
CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half d...
Praxisseminar: Medical Writing für Patient*innen - so vermitteln sie Content anschaulich und rechtssicher.
Am 1.1.2025 tritt die neue Variation Regulation in Kraft. Informieren Sie sich hier über die Änderungen. Außerdem: Varia...
Sie möchten die nächste Stufe der Karriereleiter erklimmen und Stufenplanbeauftragte*r oder EU-QPPV bei einem Arzneimitt...
This qualification course provides an in-depth exploration of EU drug regulatory affairs. With two e-learnings for self-...
Details
International experts will inform you of the latest trends in global marketing authorisation and drug safety.
Details
More than 4,500 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.
Details
