Hintergrund
Dear Colleagues,
I am pleased to invite you to the European GMP & GDP Forum, taking place from 24-26 June 2025 in Barcelona, Spain.
As many of you know, our ECA members have enjoyed biannual conferences dedicated to GMP and GDP for several years. Since 2021, we have combined these two into a unique event, bringing together the European GMP Conference and the European GDP Forum.
This three-day event is designed to provide flexibility and focus:
- The first 1½ days are dedicated to Good Manufacturing Practice (GMP), offering expert presentations, regulatory updates, and discussions on emerging trends and practical implementations.
- The second 1½ days will center on Good Distribution Practice (GDP), covering the latest developments and best practices in this area.
This flexible format allows you to tailor your participation according to your specific interests and needs. You may choose to attend only the GMP Forum, only the GDP Forum, or all three days of the event.
For our third Forum in June 2025 we have invited speakers from Regulatory Authorities, leading Organisations and the Pharmaceutical Industry to share and discuss with you the latest GMP & GDP developments.
I look forward to welcoming you to this event – on-site in Barcelona!
Yours sincerely,
Dr Afshin Hosseiny, Chairman of the ECA Advisory Board
Zielgruppe
The conference is of particular interest for GMP experts of pharmaceutical companies (e.g. QA, QC, production, regulatory affairs), of GMP inspectorates and Regulatory Authorities. It is also of interest for all personnel involved in GDP – pharmaceutical storage, transportation, cold chain and distribution activities and the control of these activities.
Programm
Gesamtes Programm als PDF herunterladen
Agenda – Day 1: GMP Forum, 24 June 2025
Welcome
Introduction – Update ECA
Dr Afshin Hosseiny, Chairman of the ECA Advisory Board
Dr Afshin Hosseiny, Chairman of the ECA Advisory Board
EMA: Update on Inspections, MRAs and Work Plan
N.N. Brussels
N.N. Brussels
- GMP/GDP Inspectors Working Group – Priorities for 2025 and 2026
- Harmonisation of Inspections in Europe
GMP Update 2025 and Outlook 2026 – Current Trends and Developments in Europe and US
Dr Ulrich Kissel
Dr Ulrich Kissel
- New concepts and elements in new directive 2023/192/EC
- The EU GMP chapters under Revision
- Supply chain reliability and security
- The matters of drug shortages
- Break Through and Prime in relation to ICH Q12
EU GMP Annex 11 – The EU Draft Paper
Ib Alstrup & Dr Wolfgang Schumacher
Ib Alstrup & Dr Wolfgang Schumacher
- Compliance requirements vs. challenges for the regulated Industry
- Pros and Cons of the draft – practitioner‘s perspective
ICH Q9 Trainingspackage: An Overview
Dr Peer Schmidt
Dr Peer Schmidt
- Overview of the ICH Q9 Revision
- Hazard identification instead of risk identification
- Formality according to ICH Q9(R1)
- Risks in drug availability
- Risk-based decision-making - a daily Task
- Dealing with subjectivity
- The risk review
Global Functions in Pharma Large Organizations and EU GMP – A Critical Discussion
Dr Ulrich Kissel
Dr Ulrich Kissel
- Why global functions? – characteristics of global function
- How far does EU GMP support global functions?
- Views and experience of the local function
- Gaps, tensions, and conflicts related to the concept of global functions
- A progressive concept to address current limitations
Summary Day 1: Impact of the Changes in GMP on the Pharmaceutical Industry
Dr Afshin Hosseiny
Dr Afshin Hosseiny
Agenda – Day 2 (morning): GMP Forum, 25 June 2025
Artificial Intelligence and Digitalization in Pharma
Dr Joerg Stüben
- How will Artificial Intelligence (AI) influence GMP?
- Benefits and Limits
- Possible consequences for the QP
- What else does the digital future bring?
Version 3.0 Equipment Qualification Good Practice Guide
Ralf Gengenbach & Dr Franz Schönfeld
Ralf Gengenbach & Dr Franz Schönfeld
- Overview about ECA´s Qualification and Validation Guide
- GEP vs GMP
- How to integrate suppliers in qualification activities
- Inspectors view on outsourcing of qualification activities
The new ECA Good Practice Guide Auditors Reference Book, Vers. 2.0
David Abraham
David Abraham
- Brief history
- The Journey to date
- Overview of current and future Content
- Possibilities for information sharing
Agenda – Day 2 (afternoon): GDP Forum, 25 June 2025
GDP Update & Outlook
Alfred Hunt
- Major GDP developments of the last few months
- Current trends in Europe and the US
- Outlook for 2025/2026
GDP Inspection Findings and Recent Trends Emil Schwan
- Inspections of the competent authorities
- Typical GDP inspection findings
Managing a GDP Inspection to Maximise the Chance of Success
Sue Mann
Sue Mann
- Importance of careful planning for a GDP inspection
- Specific roles throughout the inspection
- How to ensure the regulatory authority accepts your responses
Human and veterinary GDP regulations within the EU - are they really the same?
Dr Daniel Müller
Dr Daniel Müller
- Regulatory framework for GDP
- Current relevant guidelines on GDP
- Similarities and differences, pitfalls
- Inspection focus
Resilience in the Pharma Supply Chain
Dr Martin Egger
Dr Martin Egger
- Current disruptions in the global supply chain and their effects
- Recommendations of the EMA to strengthen the supply chain of critical medicinal products
- Mitigation measures in the supply chain
GDP Challenges and Solutions in Ukraine’s War-Torn Supply Chain
Oleksandra Bakhurynska
Oleksandra Bakhurynska
- BCP plan and reality
- Challenges in maintaining quality Standards
- Solutions and changed approaches
Agenda – Day 3: GDP Forum, 26 June 2025
Distribution Control – the magic of KPI, QPI and management dashboards for reliable GDP transports
Dr Torsten Schmidt-Bader
- Reliable pharma transports - what is wrong with global distribution?
- The world is not „GDP perfect“ - how to prepare for the worst
- Transport performance - no data, no Control
- KPI, QPI and dashboards - 5 critical process Parameters
- Feedback & feedforward - how to implement risk principles into Transportation
- Distribution control: The unknown management task in quality systems
Pharma and Healthcare Shipment Transported by Air: CEIV Pharma Certification
Mateusz Zawadzki
Mateusz Zawadzki
- IATA Temperature Control Regulations (TCR): Governance structure, regulatory context and upcoming key changes
- CEIV Pharma Program: certification scope and criteria, assessment process and upcoming enhancements
Application of AI in Modelling Logistics Solution for Frozen Drug Substance Airfreight Transport
Dr Zvonimir Majic
Dr Zvonimir Majic
- Introduction to airfreight deep frozen capabilities and solutions: Regulations beyond GDP
- Specific requirements for deep frozen APIs transported in airfreight
- The use of AI in risk-based route risk assessment for deep frozen APIs
- Airfreight route modeling and qualification under Deep frozen conditions
- Ethical considerations in use of AI in pharma-airfreight
Revolutionizing Quality Assurance through Automation – The Future of GDP
Michael Fleischer
Michael Fleischer
- The early days of GDP – GDP Compliance in the early days
- Increased complexity in GDP – The dynamics of specialized products and therapies lead to a new mindset
- Evolution of GDP to digital – The rise of Robotic
Process Automation
- Regulatory Considerations – Software qualification and validation of computerised systems
Innovation in Pharmaceutical Quality Assurance – Enhancing Compliance and Efficiency
Robert Kayum
Robert Kayum
- IT based Solutions
- Continuous improvement trends – Airlines & Logistics Partners
- Temperature Control Packaging & Supply Chain Visibility
- Optimising your supply chain through reverse logistics and reusable temperature control packaging – passive and hybrid
The Global Cold Chain Puzzle: Ensuring Compliance for Cold Chain Transportation
Tina Geyer
Tina Geyer
- Unraveling the GDP Maze: Understanding Global GDP Standards for cold chain Transportation
- Transportation: Active and passive systems
BUSINESS USE CASE: Setting up a Logistics Network Hub – to enable Sea-Freight
Saddam Huq
Saddam Huq
- Optimize Logistics Network Design
- Selection and Assessment Criteria
- Proof of concept and Target model
| ECA-Member*: | € 2580,- |
| Non ECA Member*: | € 4470,- |
| EU/GMP Inspectorates*: | € 1390,- |
| APIC Member Discount*: | € 2680,- |
| GDP Association Member Discount*: | € 2580,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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