Conference Day 2 Agenda - Wednesday 12th November

Breakfast

  1. Delegate registration and refreshments

Toxicological perspectives

  1. Opening remarks from Chair

  2. Challenges in the use of existing toxicological data for risk assessment of leachables

    Carsten B. Senholt, Principle Scientist, Diabetes Toxicology & Safety Pharmacology, Novo Nordisk

  3. Case studies of pharmaceuticals E&Ls health risk assessments

    Pete Watts, Director of Toxicology, bibra toxicology advice & consulting

  4. Networking refreshment break and poster session

Case studies of E&Ls for implantable devices and production contact materials

  1. E&L considerations for drug-filled implantable devices

    Dr James R. Scull, General Manager, NSF Health Sciences

  2. Assessment of potential Extractables and Leachables from Product Contact Items (PCIs) used in the manufacture of FE 999049 drug substance

    Leo Brenman, Senior Research Scientist, Development Department, Bio-Technology General (FERRING Pharmaceuticals)

  3. L&E Evaluation for a Biotech API Production Site

    Juergen Wilhelm, QC-Specialist, Filter and Plastics, Roche Diagnostics

  4. Lunch will be served for all speakers and delegates

E&Ls and impurities

  1. "Organic Impurity Profiling" for drug products versus "Leachable Studies" What is there to learn?

    Dr Piet Christiaens, Scientific Director, Toxikon Europe

  2. Elemental impurities from materials used in pharmaceutical applications

    Dr Dennis Jenke, Baxter Distinguished Scientist, Baxter Healthcare

  3. Influence of aggressive screening conditions and composition on the extractables from glass containers, innovative internal treatment solutions for packaging

    Christophe Wagner, Founder, Glass Surface Technology

  4. Closing remarks

  5. Conference close