Conference Report on the GDP Forum 2025 in Barcelona
This year's European GMP & GDP Forum took place in Barcelona from 24 - 26 June 2025. The first day and a half focused on GMP topics, while the following day and a half was devoted to current developments in the field of Good Distribution Practice (GDP). Participants had the option of attending either the GMP Forum, the GDP Forum, or all three days of the event.
The GDP Forum, which began on the afternoon of 25 June and continued on 26 June, focused on current challenges across the entire pharmaceutical supply chain. Speakers from regulatory authorities, industry, and consulting agencies shed light on key issues from different perspectives. The members of the Board of the European GDP Association (GDPA) also played an active role in the forum. Alfred Hunt, Chairman of the GDPA, moderated the first day and gave the opening presentation. On the second day of the conference, Dr Christian Grote-Westrick, member of the GDPA Board, guided participants through the program.
The topics covered in the presentations ranged from regulatory changes, authority inspections, and resilience in times of crisis to technological innovations, automation, and digitalization, as well as global logistics strategies and specific experiences from Ukraine. In addition to the specialist presentations, the breaks and social event provided ample opportunity for personal exchanges with colleagues from all over Europe and with the speakers. The program was complemented by three exhibitors who presented their products and services in the break areas and were on hand to answer questions.
The afternoon of the first day began with a presentation by Alfred Hunt, Hunt Pharma Solutions Ltd, UK. Under the title "GDP Update & Outlook", he gave an overview of current regulatory developments, including new Q&A documents from the EU Commission and updated guidelines and guidance documents relevant to the GDP sector. He discussed the validity of GDP certificates and emphasized that different regulations for renewal may apply in different member states. At the end of his presentation, he referred to the then ongoing GDPA survey on the implementation of GDP requirements, in which more than 100 people had already participated by the time of the forum.
Emil Schwan, Chief Pharmaceutical Inspector, Swedish Medical Products Agency, addressed the topic of regulatory inspections of marketing authorization holders in his presentation "Inspections of Marketing Authorization Holders with regard to GDP and GMP". Among other things, he explained the role and responsibilities of the MAH (Marketing Authorization Holder) in the supply chain, requirements for contracts, outsourced activities, and the issue of security in the supply chain.
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Sue Mann, Sue Mann Consultancy Ltd, UK, addressed the optimal preparation and implementation of GDP inspections in her presentation "Managing a GDP Inspection to Maximize the Chance of Success". She presented a practical approach to inspection management that takes both organizational and communication aspects into account. Particular emphasis was placed on the importance of a central "backroom" and the role of the responsible person during the inspection.
Dr Daniel Müller, Head of GMDP-Inspectorate, Tuebingen, Germany and GMDP inspector, compared the GDP regulations for human and veterinary medicinal products in his presentation entitled "Human and Veterinary GDP Regulations within the EU - are they really the same?" He pointed out that although there are differences in the wording, there is considerable overlap in terms of content. This was particularly evident in the virtually identical responsibilities of the Responsible Person in both sets of regulations.
Dr Martin Egger, CEO of Infrareal Holding GmbH & Co. KG and Pharmaserv GmbH, Germany, presented current challenges in the global supply chain in his contribution "Resilience in the Pharma Supply Chain". He analyzed causes such as the consequences of COVID-19, geopolitical conflicts, and bottlenecks in logistics networks. He discussed subsequent EMA recommendations for increasing resilience, for example through supplier diversification, safety stocks, and investments in storage capacity.
Oleksandra Bakhurynska, Quality Director, Farmsoft LLC, Ukraine, gave an impressive presentation entitled "GDP Challenges and Solutions in Ukraine's War-Torn Supply Chain", in which she described how her company is striving to continue to meet GDP requirements as best it can under the extremely challenging conditions of war. Among other things, she reported on improvised backup systems, flexible storage solutions, and simplified emergency processes.
This concluded the presentation program for the first day of the conference in the late afternoon. In the evening, participants enjoyed a guided bus tour through summery Barcelona, giving them a glimpse of the Catalan metropolis's most important sights.
The social event that followed, a group dinner, provided an opportunity for further exchange in a relaxed atmosphere. The conversations once again demonstrated how important personal encounters are for the transfer of knowledge and experience in the GDP environment.
26 June marked the second day of the GDP Forum and also the third and final day of the entire GMP & GDP Forum 2025. Dr Torsten Schmidt-Bader, Managing Director, moveproTEC - compliance & innovation advisory, kicked off the morning with a presentation entitled "Distribution Control - the magic of KPI, QPI and management dashboards for reliable GDP transports". He showed how effective distribution control can be achieved through the targeted use of KPIs, quality indicators, and dashboards. Using numerous practical examples, he clearly demonstrated how risks can be identified and minimized through data-based control.
Mateusz Zawadzki, Product Manager Special Cargo Certifications, IATA, Croatia, presented IATA's CEIV Pharma certification program. In his presentation "Pharma and Healthcare Shipment Transported by Air: CEIV Pharma certification", he explained how harmonized standards and training can secure quality in the air transport of pharmaceutical products. The focus was on reducing risks for temperature-sensitive medicines through global harmonisation of processes and communication.
Aleksandar Raic, Global VP of AI at Bridgewest Group and Technology Board Member at Pontis Technology, Croatia, explained the use of artificial intelligence (AI) in pharmaceutical distribution in his presentation "AI in Pharma Distribution: Navigating Opportunities and Challenges". He presented specific use cases, such as forecasting delivery bottlenecks and temperature deviations in the cold chain. He showed how the Internet of Things (IoT), AI, and blockchain can be integrated into a global Cold Chain Control Tower to proactively manage risks.
Michael Fleischer, GDP Expert - Logistics Compliance, and Manuel Zollondz, CCPS - Cold Chain Project Solutions, Germany, presented the transformation of quality assurance through automation in their talk "Revolutionizing Quality Assurance through Automation - The Future of GDP". They showed how robotic process automation (RPA) and digital tools can make quality assurance more efficient and reliable. Particular emphasis was placed on the need for risk-based validation of these systems in the GDP context.
Tina Geyer, Director Cluster Quality - New Markets, BeiGene Germany GmbH, Germany, addressed the global requirements for GDP-compliant cold chain logistics in her presentation "The Global GDP Puzzle: Ensuring Compliance across the Globe". She presented the relevant regulatory principles and illustrated them with specific examples of deviations and risks. Both active and passive cooling systems were presented and their suitability for ensuring the prescribed temperature ranges was explained.
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Dr Christian Grote-Westrick, Head of Quality Assurance, GDP Manager, and Lead Auditor at B. Braun Avitum AG, Germany, presented a practical approach to streamlining GDP processes in his talk entitled "Roadmap to LEAN GDP". He presented tools and checklists for digital document control, self-inspections, transport validation, and risk assessment, and showed how these can contribute to continuous improvement.
The conference concluded with a presentation by Saddam Huq, Director of Cold Chain and Logistics at GSK, UK. Under the title "Business Use Case: Setting up a Logistics Network Hub - to enable sea freight", he explained how GSK implemented a transformation from air to sea transport. He showed which technical, regulatory, and organizational requirements had to be met - from the qualification of sea containers and IT connections to the final QP approval at regional distribution centers.
Overall, the GDP Forum 2025 once again demonstrated the wide range of requirements for a secure, regulatory-compliant and efficient pharmaceutical supply chain. The technical presentations, practical reports, and technological insights reflected the increasing complexity of global supply chains and the importance of robust, future-proof GDP systems.
The GMP & GDP Forum takes place every two years. The next forum is planned for June 2027.
About the Author
Dr Markus Funk joined CONCEPT HEIDELBERG in October 2019 as operational director and is in charge of the topics GDP and analytics.
