GMP & GDP Forum 2025

Programme

Seminar Programme as PDF

• GMP/GDP Inspectors Working Group – Priorities for 2025 and 2026
• Harmonisation of Inspections in Europe

• 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

• Compliance requirements vs. challenges for the regulated Industry
• Pros and Cons of the draft – practitioner‘s perspective

• 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

• 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

• How will Artificial Intelligence (AI) influence GMP?
• Benefits and Limits
• Possible consequences for the QP
• What else does the digital future bring?

• 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

• Brief history
• The Journey to date
• Overview of current and future Content
• Possibilities for information sharing

• Major GDP developments of the last few months
• Current trends in Europe and the US
• Outlook for 2025/2026

• Inspections of the competent authorities
• Typical GDP inspection findings

• Importance of careful planning for a GDP inspection
• Specific roles throughout the inspection
• How to ensure the regulatory authority accepts your responses

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

• 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

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

• 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

• 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

• 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

• 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

• Regulatory Considerations – Software qualification and validation of computerised systems

• 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

• Unraveling the GDP Maze: Understanding Global GDP Standards for cold chain Transportation
• Transportation: Active and passive systems

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