Conference Day 1 Agenda - Tuesday 11th November

Breakfast

  1. Delegate registration and refreshments

Introductory Keynote Session

  1. Welcome from Organisers

  2. Opening remarks from Chair

  3. The European regulatory perspective

    Dr Melanie Pires, Senior Pharmaceutical Assessor, Licensing Division, MHRA

Working group guidelines and best practise

  1. Practical applications of risk-based Extractables and Leachables management

    Dr Cheryl Stults, Principal, C & M Technical Consulting, Science Advisor IPAC-RS and Former Senior Fellow, Novartis Pharmaceuticals Corp

  2. Networking refreshment break and poster sessions

  3. PQRI-PODP group update

    Diane Paskiet, Director Scientific Affairs, West Pharmaceutical Services

  4. Extractables and Leachables testing - The BioPhorum Operations Group protocol

    Aidan Sexton, Senior Process Validation Engineer, Janssen Biologics, representative of BPOG

  5. Lunch will be served for all speakers and delegates

Case studies of E&Ls in infusion pump systems and pre-filled syringes

  1. E&L challenges in infusion pump systems

    Carsten Worsoe, R&D Specialist Extractables and Leachables, CMC Analytical Support, Novo Nordisk

  2. Device change control extractables characterization and case studies for parenteral product devices. Practical solutions for ensuring patient safety and successful regulatory approval.

    Dr Alan Hendricker, Principal Specialist, Corporate/Shared Services, Becton Dickinson

  3. Extractable and Leachable studies of a Pre-filled Syringe (PFS) used for delivery of a cancer-treatment drug solubilized with high content of castor oil surfactant and alcohols

    Jianfeng Hong, Sr. Research Scientist, Chemistry Lab Manager, Extractable/Leachable Testing, Research and Development, Medical Devices Division, Fresenius Kabi

  4. Networking refreshment break and poster sessions

Simulation studies and assessment methodologies

  1. Simulation study about migration through polymers based on a diffusion model

    Dr Wolfgang Dirk, Product Manager Plastic Parenteral Vials, Gerresheimer and Dr Frank Welle, Senior Scientist, Fraunhofer IVV, Freising

  2. Comparison of methodologies for extractables assessment

    Tim Hulme, Principal Consultant, Smithers Rapra

  3. PANEL DISCUSSION - How to choose a simulation study

  4. Closing remarks

  5. End of Conference Day 1