ExpertFORUM Labelling

He has many years experience in regulatory affairs. He made a significant contribution to establishing the European DCP System

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

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.

EU Regulatory Policy and Intelligence Lead Regulatory Affairs Europe

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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Thomas, PhD, has more than 12 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.

Head CH Labeling

Global Labelling Lead Associate Director Rob Begnett is a Global Labelling Lead at Kyowa Kirin. With 30 years years of experience in pharma with 10 dedicated to safety labelling, Rob has a strong background in pharmacovigilance and transition of safety data into key product documentation. Rob believes labelling truly reaches across all company functions; from product ideation, through all phases of clinical and medical development to launch and post-approval product maintenance to end of its lifecycle. Previously, he worked as a at Reckitt Benckiser where he gained valuable experience in complex labelling projects, creating and maintaining 200 Core Data sheets which drove labelling in over 5000 product licenses globally.

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.