Online conference on current labelling topics
Webcode 24102610
Dr. Giovanna Ferrari
Pfizer Ltd., Tadworth, GREAT BRITAIN
Senior Director and Project Lead for Gravitate Health; Giovanna Ferrari is a Senior Director, Regional Labeling Lead at Pfizer. She holds a PhD from University College London and has over 20 years' experience in pharmaceutical regulatory affairs. She has a strong background in labeling and product information, having specialized in this area since 2009, and is the global business process owner for the Pfizer process for management of country labeling documents. Externally, Giovanna has represented Pfizer in a wide range of industry forums over the last few years, in particular focussing on e-labelling, and is the industry lead for a highly innovative and patient-focussed digital health information project that is being progressed via an IMI public-private partnership - Gravitate-Health.
Dr. Niklas Jänich
Boehringer Ingelheim International GmbH, Ingelheim, GERMANY
Head of Global Labeling Operations & Digitization; Dr. Jänich is an expert in Regulatory Affairs with extensive expertise in the field of labeling. In his role, he is responsible for the labeling process as well as associated systems, compliance, and digitalization. Furthermore, he advances the development and implementation of Structured Content Authoring and electronic product information in the GxP-regulated environment.
Tris Nockles
Navitas Life Sciences Limited, Portsmouth, GREAT BRITAIN
Regulatory Nets Lead; Tris leads the industry Regulatory Networks (labelnet & rimnet) at Navitas Life Sciences. With over 20 years of experience in the Healthcare industry, Tris has a strong background in Labeling, Regulatory, Quality Management and the underlying technologies. She is committed to advancing industry best practices, particularly in the E2E labeling processes and is always seeking opportunities to balance the demands of patients and regulators alongside industry working practices.
Julian Backhouse
Regulatory Affairs and Labelling Consultant, Liverpool, GREAT BRITAIN
Julian has been working at IQVIA before starting his own consultancy. During his tenure with IQVIA Technology SRQ (Safety, Regulatory and Quality) Julian has lead a dynamic team responsible for the design and development of IQVIA’s label information, content management and authoring solution. Focused on the complex challenges of the core, local and regional label change process.
Nina Malvik
Norwegian Medicines Agency, Oslo, NORWAY
Senior Adviser Product Information, QRD member, CMDh alternate; Nina Malvik is a Senior Adviser at the Norwegian Medicines Agency. With 13 years of experience in regulatory affairs, Nina Malvik has a strong background in product information. She is committed to safe and correct use of medicinal products and is always seeking opportunities to improve the ways of communication between the parties involved. Previously, she worked as a pharmacist at Adler Apotheke, Wandsbek, Hamburg where she gained valuable experience in production of sterile and non-sterile medicinal product as well as informing and educating patients and healthcare personnel in all aspect related to correct and safe use of their medicine. Nina Malvik holds MSc from University of Hamburg, Germany. She is passionate about medicinal communication and is dedicated to making communication of safe and correct use of medicinal products fit for the future.
23-24/10/2024
23-24/10/2024
Day 1: 09:00 - 17:00
Day 2: 09:00 - 12:30
You may dial in 30 min before the session.
online
online
Veranstaltung - 1,590 € zzgl. MwSt.
The fee includes a comprehensive course documentation and certificate.
Veranstaltung - 1,590 € zzgl. MwSt.
The fee includes a comprehensive course documentation and certificate.
Dr. Rebekka Bitsch
Conference Manager
+49 6221 500-565
r.bitsch@forum-institut.de
This online conference addresses the digitalisation of labelling, the transformational potential of emerging technologies like AI and how pharma companies need to prepare to implement these technologies in the regulaory affairs context.
This ExpertFORUM focuses on the digitalisation of labelling, the transformational potential of emerging technologies like AI and how pharma companies need to prepare to implement these technologies.
European authority and industry experts will provide background information on ePI and AI, as well as practical insights from pilot projects such as the EMA ePI pilot and the IMI Gravitate-Health project.
This ExpertFORUM will give you the opportunity to
09:00 Technical warm up and introduction
09:15
Dr Niklas Jänich
10:45 Coffee break
11:00
Dr Giovanna Ferrari
12:30 Lunch break
13:30
Dr Niklas Jänich
15:00 Coffee break
15:15
Tris Nockles
16:45 Final questions
17:00 Closure
09:00 Welcome and introduction
09:15
Nina Malvik
10:45 Coffee break
11:00
Julian Backhouse
12:30 Final questions and closure
Familiarise yourself with our Learning Space and gain the confidence you need by attending one of our free pre-meetings. No registration is required. You will find all the pre-meeting dates and the access information in your customer account. Pre-meeting meetings give you the opportunity to explore our Learning Space. 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.
Log in to the customer portal at https://members.forum-institut.de/login with your username (e-mail address) and password. Please ensure that you can access the customer portal prior to the event. On the day of the event, you will kick off your online training in the customer portal by clicking 'Participate' in the respective event.
Overall impression: 92 % of the participants' feedback was very good or good (October 2022)
Course content: 93 % of the participants' feedback was very good or good (October 2022)
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Here you can find the technical requirements for our online events that must be met.
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New insights in legislation, on ePI and how to be compliant with labelling.
Nice update on what is going on, exchange of experience between participants and presenters.
Very interesting insights, from different perspective.
There is not so much that can be improved. It was a well structured and organised conference on labelling topics.
I will recommend this conference to my colleagues and I am convinced we will take part at ExpertFORUM Labelling the next year.
