ExpertFORUM Labelling

Thomas, PhD, has more than 19 years’ experience in assessment of Risk Management Plans, Educational Materials, PSURs/PBRERs, PASS and safety signals. He has extensive knowledge of the European and German national pharmacovigilance regulatory (EU, GVP, AMG) environment and was member of the New PhV Legislation Transparency/Communication Project Team which developed the GVP guidance on risk communication. Training of students on risk management and PSURs are also part of his activities.

Managing Director, User Testing Consultant; Dr. Jörg Fuchs is the professional who stands for user-friendly medical information and readability tests. He is founder and head of PAINT-Consult^® - a company specialised in readability testing, usability tests, medical information, research studies and more, across the field of regulatory affairs. Having completed his pharmacy studies at Greifswald in 1996, he immediately applied himself to conducting research into the improvement and testing of patient information leaflets. This work led to a doctorate at the Humboldt University of Berlin and, since 2005, the research has continued at the Department of Drug Regulatory Affairs in the University of Bonn.
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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.

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.

Regulatory Administration Department, She has been working in regulatory affairs, especially product information, at the Medical Products Agency since 2001, member of the QRD group

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.

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.

Marina Hert is currently working as a Senior Artwork Expert. With over 10 years of experience in artwork management within the pharmaceutical industry, she possesses in-depth knowledge of artwork processes, regulatory requirements, GMP compliance, and process optimization. Previously, she held senior roles in artwork and packaging management, leading artwork and packaging projects, supporting new product launches and tech transfers, and driving continuous process improvements. In these roles, she coordinated packaging changes, ensured compliance with legal requirements, and optimized processes to achieve efficient and error-free execution. Throughout her career, she has gained extensive hands-on experience in all phases of the artwork lifecycle - from the creation and regulatory review of labeling to the technical implementation and final production release. She has continuously expanded her expertise through numerous trainings in artwork management.