Enhancing efficiency and compliance in global labelling
Webcode 25042611
Dr Barbara Briggs
Pharma Labelling Ltd, Leighton Buzzard, GREAT BRITAIN
Managing Director Barbara Briggs is an experienced regulatory professional with over 40 years in Pharmaceutical Research & Development. In development, she has mainly specialised in Labelling, from Global oversight in terms of creating and maintaining the Company Core Data Sheet, to regional labels i.e., European and International. She has managed and directed labelling projects for a wide range of products, including biologics, pharmaceuticals, and medical devices. A key area of expertise and passion is getting organizations to start with the end in mind. Labelling should shape the development program, working closely with key functions such as clinical, commercial, and market access to clearly differentiate the asset. The label is a pivotal document; it is the summary of what companies know about the asset, it is the licence with Health Authorities, informs the physician of the essential prescribing information, and forms the basis of the information for the patient. She has recently been engaged in initiatives for electronic accessibility and compliance for organisations.
Dr. Annette Wüstholz
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, GERMANY
Head of Global Labeling
11/04/2025
11/04/2025
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.
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Rebekka Bitsch
Conference Manager
+49 6221 500-565
r.bitsch@forum-institut.de
Attend this seminar to gain in-depth knowledge of the CCDS concept, global labelling requirements, and practical insights into market-specific regulations in the EU and USA.
The Company Core Data Sheet (CCDS) serves as the central reference for all information related to a medicinal product. Any errors made here-whether in content or execution-can impact package inserts worldwide, ultimately affecting the perception and use of the product. Therefore, the CCDS should not be considered in isolation but rather as part of an intricate system, involving close collaboration between all central departments.
In this seminar, you will gain a comprehensive understanding of the CCDS concept and the requirements for global labelling. We will delve into the interrelations between the CCDS, pharmacovigilance, regulatory affairs database systems, and the role of the Qualified Person for Pharmacovigilance (QPPV).
The afternoon workshop, featuring case studies, will provide practical insights into market-specific requirements (with a focus on the EU and USA), regional labelling considerations, and their influence on the CCDS.
After attending this seminar,
Welcome and technical instructions
Dr Annette Wüstholz
Short break
Dr Barbara Briggs
Lunch break
Dr Annette Wüstholz
Coffee break
Dr Barbara Briggs
Seminar end
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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