Education Tracks
Regulatory/Compliance
Focus on how product quality initiatives are taking a “center stage” in the industry. Examine the latest trends in quality initiatives and regulatory thinking from around the world. The recognition and implementation of the ICH guidelines will have a dramatic impact on every facet of drug development and delivery. Understand what the new initiatives say, and do not say. This track has critical information for all aspects of the industry.
Track Leaders
- Paul D’Eramo, Executive Director, Quality and Compliance Worldwide, Johnson & Johnson, USA
- Ronald Branning, Principal Consultant, Commissioning Agents, Inc., USA
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Manufacturing
A new heightened awareness of risk management is one aspect of the industry today. The Manufacturing track will feature sessions focused on implementing new platform technology, managing manufacturing in a risk-based paradigm, and investigating the financial impacts of these elements for the future.
Track Leaders
- Ray Scherzer, Senior Vice President, Engineering, GlaxoSmithKline, USA
- Larry Kranking, Senior Vice President, Operations, Monosol RX, USA
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Facilities and Engineering
Examine how new Quality by Design (QbD) initiatives impact the implementation of design programs. New products and technologies will challenge the concept of faster and cheaper delivery, along with new riskbased execution philosophies.
Track Leaders
- James Kimmel, Director of Engineering, Cephalon, USA
- Thomas Trevithick, Vice President, Integrated Engineering Management, Wyeth, USA
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Innovation
Newly enhanced, ISPE Communities of Practice (COPs) provide the opportunity for you to connect with fellow colleagues and collect innovative ideas — what’s new, what’s here today, and what’s coming soon. ISPE COPs have quickly become the home for discussions on hot industry topics. Many of the sessions in the Innovation track will focus on the industry-impacting topics brought to light by COPs.
Track Leaders
- Timothy Tyson, President and Chief Executive Officer, Valeant Pharmaceuticals International, USA
- David Selby, Managing Director, Selby Hope International, Ltd., UK
- Sion Wyn, Director, Conformity, Ltd., UK
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Investigational Products
Participate in a dynamic track with a focus on innovation and strategic partnerships. Find out about industry success stories and increase your ability to deliver today and tomorrow. Share in the discussion of‘hot topic’ issues facing Investigational Products (IP) professionals. Hear from industry experts on topics such as driving Innovation in R&D, clinical supplies forecasting and planning, China’s distribution channels, and forensic science. Get updated on current legal issues facing IP.
Track Leaders
- Michelle Foust, PharmD, Director of New Product Development, Almac Clinical Services, USA
- Paula Mastrangelo, Associate Director, Bristol-Myers Squibb, USA
- Bernd Steffens, Global Head, Clinical Trial Supplies Unit, Boehringer Ingelheim Pharma GmbH & Co., GERMANY
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Project Management
In order to deliver facilities in half the time, project management is critical. Attend this track to analyze current innovations in project delivery, understand and learn how to implement new regulatory guidance, and discuss how it will impact projects in the future. Participate in discussions on successful project execution for a wide variety of project types. Take advantage of valuable insights from industry experts discussing how current and future trends can be used to transform current projects, and help shape future project execution.
Track Leaders
- Peter Bigelow, Senior Vice President Consumer Healthcare Manufacturing, Wyeth Pharmaceuticals, USA
- Andrew Skibo, Vice President, Corporate Engineering and Capital Projects, Amgen, USA
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Guides and Guidance Documents
Attend the launch of new guidance documents that will impact your work. Review the updated Oral Solid Dosage Baseline® Guide and the new Maintenance Guides, just two of the topics presented by leading industry experts. Implementation of the risk section of the updated Guide, commissioning and qualification, laboratory practice, and new design standards will be featured in this track. Receive first hand access to new guidance that can impact operations today.
Track Leaders
- Brian Lange, PE, Director of Engineering, Merck & Co., Inc., USA
- Gert Moelgaard, Vice President, NNE, DENMARK
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