2014 ISPE Investigational Products Conference


Programme Agenda » ( 168 KB)

Wednesday, 17 September

09:00 - 09:05  Welcome and Introductions
  • Leader: Henryk Junker, Deputy Quality Director, Hospira Ltd UK, United Kingdom
09:05 - 09:45  Plenary Speaker with Q & A
09:45 - 10:25  Plenary Speaker with Q & A
10:30 - 11:00  Networking Break
11:00 - 11:45  Current Regulatory Challenges: Implementation of EU-GDP and Shortages for Medicinal Products
11:45 - 12:15  Vendors and Sponsors - Two sides of the same Clinical Supply coin
12:20 - 12:50  Clinical Supply Chain Planning Case Study
13:00 - 14:00  Lunch
14:00 - 15:30  

Concurrent Workshops/Walking Forums

New GDP impact on CT distribution experience with GDP regulation/risk assessment of ambient shipping
Sebastian Delporte, QA Logistics Manager, Eli Lilly
  • Understand what are the major changes brought by this new regulation and what are the expectations for its application to the CT materials distribution.
  • Go through an overview of the challenges for its implementation as the qualification of the Carriers, wholesaling- material sourcing, and the shipments of the Room Temperature products.
  • More specifically detailing an option on how to satisfy the requirements for the Room Temperature products shipment, using a risk assessment of the distribution lanes and the screening of the technologies available to reduce the risks (associated to the control of the extra costs).

Challenge of outsourcing (End to End vs. fractionate)
Meinrad Kopp, Ph.D., Head External Networks Management, Merck, Switzerland
  • The workshop is to address different philosophies (end to end versus fractionate) of outsourcing clinical packaging and labeling work to external vendors.
  • Case studies will be presented for various scenarios (by the workshop leader).
  • The workshop attendees are supposed to discuss Pro's and Con's, identify risks and risk mitigation strategies for each scenario.
  • Workshop participants are welcome to share their ideas about best practices and share their own companies practices with each other.
  • Workshop attendees should be able to summarize discussions and get concurrence on an outsourcing model going forward.
15:30 - 16:00  Networking Break
16:00 - 16:30  Case Studies of Lean Supply Chain Application in Investigator Initiated Studies
  • Melanie Blessing, Head Therapeutic Area Supply Chain Management Cardiometabolic Diseases, Boehringer Ingelheim Pharma Gmbh, Germany
    Case Studies of Lean Supply Chain Application in Investigator Initiated Application
16:30 - 17:30  End to end blinding
17:30 - 18:30  Welcome Reception at the Hotel
19:00 - 22:00  Networking Event at Off-site Venue

Thursday, 18 September

09:00 - 09:10  Welcome and Introduction - IP COP
  • David Glynn, Assoc. Director, Project Management, Sunovion Pharmaceuticals Inc, USA
09:10 - 10:05  What is changing within GCP? What can be done to optimize the patient/site experience? An Inspector's View
10:05 - 11:00  Update on Clinical Trial Regulations
11:00 - 11:30  Networking Break
11:30 - 12:15  Expanded Access Programme
12:15 - 13:00  Direct Subject Distribution
13:00 - 14:00  Lunch
14:30 - 15:00  

Concurrent Workshops/Walking Forums

Direct Subject Distribution
Massimo Eli,Clinical Supply Regional Lead, MSD

The increasing global nature of studies can result in long travel times to clinical sites for patients which can compromise compliance and result in patients withdrawing from studies. Explore options to support the site and improve patient compliance through delivering clinical supplies direct to patient homes.
This is a new and developing opportunity for the clinical supply chain with varying formal country regulation. Investigate different experience on this area.

Innovative Patient Solutions
Sascha Sonnenberg,VP, Commercial Operations, Marken Ltd.

What are the most important and realistic innovations patients, sites and sponsors can benefit from in the next 5 to 10 years? Where and what are the limits of innovations in the Clinical Trial Supply Area? Attendees will learn about new technologies that will help to increase patient safety, improve compliance but on the other side will also allow to increase efficiency. It will also be discussed if all innovation will result in cost savings.

    15:30 - 15:50  Patient Survey Update
    15:50 - 16:00  Closing remarks - Voting on 2015 topics
    • Leader: Henryk Junker, Deputy Quality Director, Hospira Ltd UK, United Kingdom



    Anthony Moult, EFPIA Representative, Director Clinical Supply Operations, Daiichi-Sankyo, UK

    Terry Walsh, Head, Comparator Network, TransCelerate BioPharma Inc., USA

    Christoph Honermann, Global Prduct Manager Life Science, DACHSER GmbH & Co. KG, Germany

    Belén Escribano Romero, Ph.D. Head of the Pharmaceutical Inspection and Enforcement Department, AEMPS - Spanish Agency for Medicinal Products and Medical Devices, Spain

    Jason Wakelin-Smith, GCP & GLP Inspector, MHRA, UK


    Chair: Henryk Junker, Senior Manager, Clinical Quality, Allergan Ltd, UK

    Massimo Eli, Ph.D., Clinical Supply Regional Lead, MSD Italia SrL, Italy

    Karen Gram, Principal Specialist, Novo Nordisk A/S, Denmark

    Marianne Oth, Ph.D., Manager, Quality Assurance, Lilly Clinical Operations SA, Belgium

    Esther Sadler-Williams, Global Director, Catalent Pharma Solutions, UK

    Julian Schulz, Associate Director Clinical Supplies, Takeda Development Centre, UK

    Bernd Steffens, Ph.D., Head Global Clinical Trial Supplies Unit, Boehringer Ingelheim Pharma GmbH & Co., Germany

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