GDP Part (25 & 26 June 2025)

Agenda 25 June 2025 (afternoon)

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

  • 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

  • Regulatory framework for GDP
  • Current relevant guidelines on GDP
  • Similarities and differences, pitfalls
  • Inspection focus

 

Resilience in the Pharma Supply Chain

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

  • BCP plan and reality
  • Challenges in maintaining quality standards
  • Solutions and changed approaches

 

PDF

Click on the picture to open the complete programme as a PDF.

 

To the GMP Part

Agenda 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Optimize Logistics Network Design
  • Selection and Assessment Criteria
  • Proof of concept and Target model
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