The Workshop

PRE-CONFERENCE WORKSHOP
Integrating technology into the clinical supply chain
Workshop chair:		Marisa Ehinger Director Product Development ALMAC
Date:		Tuesday June 2 2009 1.30pm – 5.30 pm
About the workshop
Like all industries, clinical supplies must deal with the constant need for improvement in terms of more efficient and innovative processes. Within this context, many pharma and biotech companies now expect “joined up thinking” - experts and systems in different disciplines working in tandem to deliver clinical supplies as efficiently as possible. This half-day, afternoon workshop examines the key factors in today’s market for successful supply delivery, powered by effective supporting technologies.
Workshop agenda
	1:00	Delegate registration and coffee
	1:30	IXR Technology and the supply chain Examines and outlines how IVR systems interface with the clinical supply chain.	Les Hanson Client Development Lead ALMAC
	2:00	Managing an expanding global clinical supply network The global distribution of clinical materials and IVR systems has many points of interface. This presentation examines the factors affecting global distribution that sponsor companies should take into account of when building IVR systems.	Anthony Mistretta Distribution Manager ALMAC
	3:00	Tea / Coffee Break
	3:15	Applications to improve the supply chain for existing technology Examines the anatomy of a software application and gives an overview of forecasting / simulation tools and how they can be used effectively within a trial. This overview also examines the benefits of drug pooling strategies using detailed case studies.	Marisa Ehinger Director, Product Development ALMAC
	4:00	Pulling it together – integrated project management As Project Managers are the day-to-day contact points for most sponsors, this overview examines how clinical supply and IVR staff can work together in an integrated fashion to enhance the delivery of supplies within a clinical study.	Sapna Kirpalani Senior Project Manager ALMAC
	4:10	Client Case Study Actual case study of how Antisoma have benefited from outsourcing clinical supplies and IVRS to one provider. Also explores the pitfalls of a fragmented supply chain
	5:15	Conclusion and close of workshop
About Almac
Almac offers an integrated supply chain management solution that draws on the expertise of its best-in class clinical trial supplies and IVR/ web based services. Its integrated solution does more than just combine related services under one roof; it incorporates supply planning, technology implementation, and project oversight into a unified study start-up and management approach that optimizes the supply chain at each level. Almac and its affiliated companies provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, API manufacturing, clinical trials and drug manufacturing. US operations are based in Pennsylvania, North Carolina and California. European API manufacturing, clinical trials and drug manufacturing. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh. www.almacgroup.com

POST-CONFERENCE WORKSHOP
Coping Strategies for Change
Date:		June 5, 2009
About the workshop
This workshop is aimed at those involved in labeling management for clinical trials. The programme includes presentations, a demonstration and a round table discussion on key industry trends and changes likely to impact labeling management. This workshop aims to equip you with the knowledge to: Update your view of current trends and changes in the market Evaluate and identify the likely impacts of current industry trends and changes on your label management List and evaluate the risks and potential pitfalls of current labeling practice/processes List most common FDA/global compliance pitfalls and how to avoid them Detail how new technology can deliver advantages and list the benefits Evaluate your own label management in relation to best practice examples Specify the critical elements of an effective labelling solution that will stand up to future changes At this event you will hear presentations on: key industry trends based on a recent report from the Economist Industry Briefings how these changes impact labeling management some common practice label management sins (case study based) the key features all effective label management systems share how new technology can support effective clinical trial label management Round Table Discussion You will also have the opportunity to take part in a lively round table discussion on these issues. Two Free White Papers All attendees will receive 2 free white papers, a summary of the round table discussion and copies of all the presentations.
Workshop agenda
	8:00	Delegate Registration and Coffee
	8:30	Workshop welcome and introduction
	8:35	Industry trends affecting clinical trials management A look at the key industry trends and how they are impacting clinical trials management. Including merger and acquisition activity, pressure from generics and an increased focus on reducing costing and speeding up time to market.
	9:00	Clinical trials labeling management – best practice and pitfalls This presentation will examine how the trends above impact labeling management and share case study examples of how leading companies are tackling key issues including efficiency, accuracy and legislative compliance. Also a candid look at some clinical trials labelling sins.
	9:30	Taking advantage of new technology A look at the trend for web based systems and the key considerations and advantages that apply to a clinical trials application. This includes a live demo of a clinical trials labeling management system.
	10:30	Round Table Discussion This round table session focuses on successful ways in which companies are dealing with pressure to reduce costs and speed up time to market. And is also an opportunity for open discussion of issues and potential pitfalls of different approaches.
	11:30	Networking and Refreshments
About PrisymID
PRISYM ID works with many of the world’s largest pharmaceutical and medical device companies, providing validated life sciences labelling management solutions for over 20 years. Specialising in FDA 21 CFR part 11 compliance, PRISYM ID's Medica product is the world's only GMP based, purpose designed labelling management software for FDA regulated environments. www.prisymls.com