PDA Parenteral Packaging Conference 2026

Topics we are looking for:

• 1. Regulatory Updates
  • Revisions from Global Pharmacopeias and ISO Standards
  • PDA Technical Reports
  • FDA Guidances
  • ICH Q3D - Elemental Impurities and Their Application to Packaging Materials
  • ICH Q3E: New Guideline in Development on Extractables & Leachables
  • Implications of EU GMP Annex 1:2022
  • Managing Post-Approval Changes
  • Real-World Examples for Practical Solutions for Compliance with Regulations
  • Control Strategy
  • Substances of Concern
• 2. Drug-Container Interactions
  • Silicone Layer Distribution and Silicone Layer Interactions
  • Extractables and Leachables
  • Delamination
  • Incompatibilities, Degradation, and Other Formulation Considerations
  • Fogging
  • Particles – Origins and Characterization
• 3. Design and Materials of Components and Containers
  • Defects and Their Categorization
  • Surface Modified Materials and Material Science
  • Permeability of Containers/Closures
  • Innovative Containers (e.g., ATMPs, Ophthalmics)
  • Considerations for Biocompatibility
  • Applications, Benefits, and Limitations of Glass and Polymer Containers
  • Large Volume Bags
  • Blow-Fill-Seal
  • Rubber/Elastomer Components, Caps, Labels
  • Traceability and Anti-Counterfeiting
  • Smart Packages: User Interactions and Drug Compliance
  • Systems for Drug Administration (e.g., CSTDs)
  • Modeling, Robotics, and Automation (e.g., Digital Twins)
  • Applications of Artificial Intelligence
  • Secondary and Tertiary Packaging
  • Validation of Packaging Solutions and Packaging Performance
  • Packaging Design Suitable for Healthcare Practitioners and Patients
  • Perspective from the Pharma Industry vs. Suppliers on Drug-Packaging Interaction
  • Perspective Along Entire Chain from Design to Application
• 4. Container Closure Integrity (CCI)
  • Product-Package Development
  • Strategies for CCI Assurance (Container Closure System Qualification)
  • API Storage Containers and Single-Use Equipment
  • Influence of Pressure and Mechanical Stress During Shipping
  • Relationship Between Visual Inspection and CCI Testing
  • CCI Testing Across the Product Lifecycle and Different Test Methods
  • CCI Phenomenology and Failure Mechanisms During Deep Cold Storage
  • Positive Controls
  • Simulation and Modeling
  • Product Release Specification vs. Internal Quality Criterion
• 5. Processing and Product Distribution/Storage
  • Sterilization and Decontamination (e.g., Vaporized Hydrogen Peroxide, Gamma Irradiation, Nitrogen Dioxide)
  • Container Handling and Reduction of Breakage
  • Fill-Finish Operations and Filling/Sealing Technologies and Controls
  • Particles and Visual Inspection
  • Approaches and Solutions for Deep Cold/Cryogenic Storage
  • Challenges in Shipping, Distribution, and Last-Mile Distribution
  • Track and Trace: Serialization and Single Unit Identification
  • Real-Time Digital Quality Control across Shelf Life
  • Integrity and Statistical Risk Assessments
  • Labeling
  • Preparedness for the Next Pandemic
  • Ready-To-Use-Concepts
• 6. Re-Thinking Packaging for Sustainability Adaptation
  • Impact of Planned Ban of Per and Polyfluoroalkyl Substances (PFAS)
  • Considerations and Solutions for Substances of Very High Concern (SVHCs)
  • Nitrosamines and Other Contaminations
  • Product Carbon Footprint Calculations/Life Cycle Assessments (Cradle to Gate/Cradle)
  • Recycling and Reuse Solutions for Primary/Secondary Packaging/Injection Devices
  • Solutions to Reduce Product Carbon Footprints and to Realize Net-Zero Products
  • Circular Economy, Circular Packaging, and Circular Devices
  • Eco-Balance and Lifecycle Assessment Beyond Carbon
  • Eco-friendly Design & Material
  • Disposal Practices Today and Tomorrow
  • Water, Waste, and Energy Reduction Programs in Packaging Manufacturing and Fill-Finish
  • Regulations: Hurdles and Incentives for the Transition to Net-Zero and Sustainable Products
  • Reducing Hazardous Drug Waste Through Innovative Packaging (e.g., Multidose Vials, Dose-Tailored Vials)
• 7. Business Continuity
  • Package Development
  • Applications for New Package Solutions
  • Machinability of Packaging
  • Safety Aspects
  • Packaging Platform Technology
  • CDMO: Challenges, Selection, and Management
  • Technology Transfer and Scale-Up
  • Solving Supply Chain Issues (e.g., Single-Sourcing, Quality Issues, Lead Time)
  • Business Development and Strategic Partnership
  • Solving the Challenge of Cost Increase
  • Global vs. Local Production