GMP/GCP Interface at Investigator Sites
Rebecca Stanbrook, Group Manager, Inspections (GCP), MHRA, United Kingdom
What knowledge do you have of investigator sites as a supplies person?
Do you understand the difficulties faced at investigator sites?
This session will present delegates with problems encountered by sites and discovered during inspections, and will provide an in-depth analysis of the root cause.
Clinical Trial Supplies staff do not see the feasibility to store product at the investigator site and the
problems associated with particular presentations of supplies for patients. This session will provide
delegates with better understanding of what happens to the IMP at investigator sites and will include an
overview of issues for investigators, site staff and patients. It will give delegates concrete examples of
how the supplies staff can ensure the site staff have the information they need. It will explore the
different issues associated with investigator sites and their impact on patients, site and sponsor
Regulatory Challenges in the GMP Clinical Supply Chain
Anthony Moult, A.N. Moult Consultancy Services Limited
The Future of the Clinical Supply Chain: How does your Clinical Supply Chain Survive in these Days
of Change and Mergers?
Dr. Alexander Debets, Site Head, Merck, Netherlands
The pharmaceutical industry is undergoing a period of unprecedented change resulting from restructuring of many pharmaceutical companies through mergers and acquisitions. This session will provide delegates with valuable insights on how to manage a clinical supply chain in times of organisational change.
Planning Across the Entire Supply Chain
Paul Skerker, Director, Supply Operations, Millennium Pharmaceuticals, USA
Technology Now and Future Potential for Clinical Supplies
Hans Heesakkers, Senior Manager, Accenture, Netherlands
New technologies like cloud computing, social networks, JIT Labelling, mPRO, ERP, EBR and 3D imaging are
making their way into the modern world.
This presentation will show how new technologies have a business case in the future clinical supply chain.
Introduction to IP COP and Overview of Good Practice Guide for NonIMPS
Esther Sadler-Williams, Senior Director, Strategic Alliances, Catalent, United Kingdom
This session aims at raising awareness among delegates of ISPE IP COP and of the opportunity to participate in ongoing initiatives within COP.
This presentation will provide delegates with:
Booklet Label Good Practice Guide
Karen Gram, Principal Specialist, Clinical Supplies Labelling & IT Novo Nordisk, Denmark
This session will present the benefits of creating a Booklet Label Good Practice Guide and highlight the
recommendations to standardise the design of a booklet label.
It will stress the importance of performing a gap analysis between the good practice guide and the company’s current practice, in order to assess the benefits of changing the current practice.
Working with Clinical Sites
Christine Milligan, Director Client Services, Fisher Clinical Services, UK
Clinical Supplies in China
Andrea Zobel, Senior Director, Head of Global Clinical Trial Distribution, Marken, Germany
Michael Arnold, Senior Director Strategic Partnerships, Global Clinical Supply, Pfizer, USA
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