Maintenance and sustainment of human medicinal product approvals
Webcode 26062610
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.
10/06/2026
10/06/2026
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 OFFERS
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 (€290 instead of €390 plus VAT).
290,00 €
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 OFFERS
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 (€290 instead of €390 plus VAT).
290,00 €
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 €
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@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. All relevant updates introduced by the Commission Delegated Regulation (EU) 2024/1701 will be covered.
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.
09:00 Welcome, introduction and technical check
09:15
Dr. William Shang
09:45
Ingrid Prieschl
11:15 Coffee break
11:30
Siniša Belina
13:00 Lunch break
14:00
Dr. William Shang
14:30
Dr. William Shang
15:15 Coffee break
15:30
Ingrid Prieschl
16:30 Final questions and discussion
17:00 End of seminar
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.
Simply register for the seminar by clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€390 + local VAT rather than €490 + local VAT).
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).
This seminar is part of the qualification course 'EU Regulatory Affairs Manager', which provides an in-depth exploration of EU drug regulatory affairs. With two e-learnings for self-study and three live online seminars led by regulatory affairs experts, participants will acquire comprehensive knowledge and practical strategies for successful marketing authorisation applications and lifecycle management in the EU.
Are you not only interested in the marketing authorisation procedures but in all regulatory affairs processes? Search for the webcode 10032 on our website for more information and registration or simply click on the link below:
Qualification Course: EU Regulatory Affairs Manager
By booking the qualification course you will save up to 25% compared to individual bookings.
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.
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Very well organised training
informative, based on practice,clear language
11.12.2024
covered all important topics plusupcoming changes
11.12.2024
