ExpertFORUM Labelling

-requested-
Senior Expert Pharmacovigilance, Bonn, Germany

Head of Risk Management II;
After earning his doctorate in medical microbiology, Dr Grüger began his career in 2004 as a Clinical Assessor in marketing authorisation within public administration. He went on to hold several positions and gained solid experience in the assessment of risk management plans, educational materials, PSURs/PBRERs, PASS, and safety signals. He has extensive knowledge of European and German pharmacovigilance requirements (EU, GVP, AMG) and was a member of the project team on "New PV legislation - Transparency/Communication", contributing to the development of GVP guidance on risk communication. He is also involved in training students in the areas of risk management and PSURs.

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.

Dr. Falk Pharma, Freiburg, GERMANY

Helena Treiber is Regulatory Affairs Manager Medicine & Labelling at Dr. Falk Pharma GmbH, with over 15 years of experience in Regulatory Affairs. She is dedicated to labelling compliance and process optimisation, and brings a practical, solution-oriented approach to regulatory challenges. Helena is passionate about continuous improvement and advancing efficient, compliant labelling practices.

PlassmannLEGAL Stuttgart, Germany

Lawyer;
Dr Kirsten Plaßmann advises companies in the pharmaceutical, medical devices, cosmetics and food industries with a special focus on regulatory issues in the areas of development, distribution, compliance, advertising and demarcation. Her further focus is on the representation of companies in and out of court in competition law disputes and vis-à-vis authorities and notified bodies.

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.

Medical Products Agency (MPA),
Uppsala, SWEDEN

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

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.

Senior Artwork Specialist, Johnson & Johnson,
Schaffhausen, SWITZERLAND

Marina Hert is currently working as a Senior Artwork Specialist bei Johnson & Johnson in Schaffhausen, Switzerland. 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.