Conference Day 1 Agenda - Thursday May 8th

Extractables and Leachables would like to thank our main sponsor, SGS, for their support towards this agenda.

Breakfast

  1. Delegate registration and continental breakfast will be served

Keynote Regulatory Session

  1. Welcome from Organizers

  2. Opening remarks from Chair

  3. Opening keynote regulatory address from FDA

    Dr Ingrid Markovic, Special Advisor to the Associate Director for Review Management, Office of the Center Director, Center for Biologics Evaluation and Research, Food and Drug Administration

Approaches for designing extraction studies

  1. A knowledge based approach to extraction studies

    Dr Daniel Norwood, Distinguished Research Fellow, Boehringer Ingelheim

    • The intellectual process of designing an extraction study based on knowledge of the packaging system, the purpose of the extraction study, and experience based best practices
    • Information available from an extraction study
    • The concepts of "to a reasonable degree of scientific certainty" and "due diligence"
  2. Networking refreshment break and chance to view posters

  3. Mind the Gap - A sharing of knowledge to aid in the correct approach towards E&L testing

    Tamara Fridman, CEO, Vanasyl LLC

  4. Chemometric approach for designing an extractable screening study

    Dr Jim Castner, Pharma Interface Analysis, LLC

    • Chemometric based approach for developing strategies regarding investigations of Extractables
    • Database of extractables used to statistically profile the distribution of physical/chemical properties
    • Analyses provide efficiency in designing screening studies
  5. Q&A Session

  6. Lunch

    Sponsored by Avomeen Analytical Services

Working group updates

  1. Update on the workings of USP Chapters 1663 and 1664

    Desmond Hunt, Sr. Scientific Liaison, Department of Standards Development, United States Pharmacopeia

  2. The ELSIE Materials Pilot Program: Observations from a Broad Multi-lab Extraction Study

    Marta Corcoran, Scientist II, MedImmune and representative of ELSIE

    • Testing of the controlled extraction studies protocol
    • Usefulness to collect and share extraction study information from a variety of plastic materials
    • Key outcomes
  3. Goals and Objectives of the PQRI's Parenteral and Ophthalmic E&L Working Group

    Dr Edward Smith, Principal Consultant, Packaging Science Resources, LLC and member of PODP group

    The PQRI-PODP group will be displaying posters around the conference room and Ed Smith will provide an introduction to the thought process behind these posters.

  4. Networking refreshment break and chance to view posters

21st century risk management and risk assessment

  1. Case studies of E&Ls health risk assessments

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

    Including substances leaching from devices into e-cigarette formulations

  2. Risk evaluation and strategic management of extractables and leachables

    Dr Cheryl Stults, Senior Fellow, Novartis Pharmaceuticals Corp, representative of IPAC-RS

  3. Panel discussion on 21st century regulatory initiatives and risk assessment

  4. Closing remarks

  5. End of Conference Day 1

Evening Activity

  1. All speakers and delegates are invited to join us for informal drinks and an opportunity to reflect on the day's proceedings, before heading out to explore either what Silver Spring, or nearby Washington DC has to offer