Education Sessions
Investigational Products – Delivering Quality by Design
Operations Track (501)
Management Track (502)
| 27 October 13.30-17.00 28 October 08.15-11.30 and 14.15-17.15 29 October 08.15-11.15 |
Track: Investigational Products |
ISPE CEUs: 1.0 each; Application for ACPE Accreditation is in process.
(PDF Current as of 9 October 2008)
The ISPE Investigational Products Community of Practice (IP COP) is a unique global organization with a common global strategic vision that supports industry professionals worldwide by providing relevant, timely and cutting-edge information as well as access to solutions and resources in all aspects of the IP supply chain. In response to your feedback, a portion of this year’s educational forum is segmented into two tracks to better meet the needs of the attendees. Although we will ask you to register for a particular track, attendees are free to engage in topics and sessions delivered in each of the tracks, based on your interest in topics.
- The Operations Track (501) will focus on tactical challenges industry professionals face in their day-to-day lives and how to overcome them
- The Management Track (502) will focus on strategic issues faced in managing an IP organization
The education forum kicks off with four workshops. Workshops are focused and interactive sessions where participants will have the opportunity to provide their own perspectives on each topic and takeaway actionable solutions.
Operations Track Workshop Themes
- Distribution Management
- Protocol Management
Management Track Workshop Theme
- Beginner and Advanced discussion on Business Process Management
Joint general sessions will continue to address the challenges of delivering in our global regulatory environment. Choices will be available in the tracks, topics to include:
Operations Track
- Management of trials in emerging markets
- Forecasting technology
Management Track
- Talent management
- Strategic decisions regarding emerging markets
Afternoon break-out sessions will provide the opportunity to delve deeper into these topics and gain from shared experience with your industry colleagues. Our popular Wildcard session allows you to bring forth the topic of your choice.
How You Will Benefit
At the end of this session, participants in the Operations Track will be able to:
- Relate challenges and risks faced in distributing clinical supplies and employ solutions/ suggestions to mitigate these challenges and risks
- Examine tools/solutions for forecasting clinical supply needs
- Discuss challenges associated with comparator sourcing and controlled substances
At the end of this session, participants in the Management Track will be able to:
- Evaluate and assess benefits of business process management and how it applies to an Investigational Products (IP) group
- Discuss solutions on how to improve colleague training and retention in IP groups
- Engage in discussion on the benefits and risks of strategically going into emerging markets
At the end of this session, participants overall will be able to:
- Articulate real challenges and solutions in the IP community
Technical Documents - www.ISPE.org/publications
- Comprehensive Guide to Clinical Materials
- ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
Who Should Attend
Investigational products professionals from all levels of the
pharmaceutical and biotechnology industry—pharmaceutical
companies, generics, and third party vendors
ISPE Communities of Practice (COPs)
Investigational Products (IP) and Packaging
Investigational Products Program Planning Committee:
- Michael Arnold, RPh, Business Process Head, Global Supply Chain, Pfizer Inc., USA
- Michelle Foust, PharmD, Director New Product Development, Almac Clinical Services, USA
- Neal Gordon, Senior Director CMC-USA, Organon a Part of Schering Plough Corporation, USA
- Kunal Jaiswal, Planning Committee Chair, Associate Director, Clinical Supplies, Schering-Plough Company, USA
- Paula Mastrangelo, Associate Director, Bristol-Myers Squibb, USA
- Robert Pizzie, PhD, Senior Director Global Clinical Supply Planning, Schering-Plough, USA
- FDA Invited
Session Speakers
- Kevin Bardonner, Team Ldr, Clinical Supplies, Eli Lilly & Co, USA
- Anne Marie Bencivengo, Drug Supply Manager, Bristol-Myers Squibb, USA
- Lisa Berdan, Assistant Director, Duke Clinical Research Inst., USA
- Timothy Brewer, Vice President Global Logistics, Fisher Clinical Services Inc, USA
- Lorna Briddick, GCS Regional Lead Latin America, Schering- Plough Corporation, USA
- Stephen Byrn, Professor, Purdue University, USA
- Sandra Cook, Supply Chain Project Manager, AstraZeneca, USA
- Graeme Currie, VP, Clinical Devlopement, PDL BioPHarma Inc, USA
- Kristen DeVito, Director of Operations, Aptuit Inc, USA
- Julie Jacobs, Director Clinical Services, ALMAC, USA
- Efim Kelman, VP, Clinical Operations, Worldwide Clinical Trials, Russia
- Michael Ku, VP, Clinical Pharmacy Svcs, Genzyme Corp, USA
- Robert Misher, President, Misher Pharma Consulting Svcs LLC, USA
- Patricia Moore, Sr. Dir, Clinical Proj. Mgmt, Genentech, USA
- Karen Oliver, Global Accounts Director, World Courier Inc, USA
- Debra Reisinger, Director, Global Clinical Ops, Schering Plough Corporation, USA
- David Riege, Associate Research Fellow, Pfizer Inc, USA
- Dinkar Saran, Principal, PRTM,
- Louise Shennard, Drug Supply Manager, Bristol-Myers Squibb, USA
- Kenneth Sosnowski, , Bristol-Myers Squibb, USA
- Justine Swinney, Distribution Project Manager, Schering-Plough Research Institute, USA
- Kevin Webb, Director of Supply Chain, BioMarin Pharmaceutical, USA
- Leon Wyszkowski, Vice President & General Manager, Fisher Clinical Services, USA