Clinical Trial Supply Europe Conference

Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
World’s leading clinical trial supply experts will help you to:
Cut overages and save money by successfully adopting S&OP processes
drawn from commercial supply into a clinical setting: GlaxoSmithKline show
you how they increased supply flexibility whilst positively impacting their
bottom line
Maintain compliance with the evolving regulatory landscape: the
MHRA and Dutch Healthcare Inspectorate discuss the latest changes to
Annex 13 and GDP regulations and how you can meet these requirements in
your business
Effectively support emerging clinical trial designs such as adaptive
trials: Merck, Sharp and Dohme share their experiences of successful
adaptive trials and the project team structures that deliver success
Ensure product viability of temperature controlled clinical materials
by establishing an effective cool chain on a global and local scale: the PDA and
ActoGeniX N.V. discuss the latest strategies to ensure success on a global
scale
Guarantee uninterrupted supply in emerging markets such as Eastern
Europe and Latin America: Galapagos NV and Merck share their most
recent experiences and show you how to overcome the major hurdles
www.clinicalsupplyeurope.com
Successfully cutting costs and overages whilst increasing the flexibility and
reactivity of your clinical supply network to support global clinical trials
Two Day Conference: 27th-28th January 2011 Pre-Conference Focus Day 26th January 2011
Venue: World Trade Centre, Rotterdam, The Netherlands
Register and Pay Before
the 24th September and
Save up to €1,797!
Limited to the first 20 registrants!
TOP 4 reasons to attend Europe’s leading industry forum:
1. Exclusive to Pharma IQ: Clinical Trial Supply Leaders Focus Day! NO presentations, 100% discussion!
2. Evening Drinks Reception and Gala Dinner: a great opportunity to increase your network
3. Exclusive to Pharma IQ: Interactive Crisis Management Session: Develop a plan of action for a
particular crisis you will come face-to -face with in your work. Find out how others tackle the same
challenge
4. 30 expert speakers: The largest gathering of expert clinical
trial supplies speakers
Clinical Trial Supply Leaders Focus Day:
NO presentations, 100% peer-to-peer discussion!
Interactive Specialist Discussion Forums:
A: Developing a Robust and Compliant Process for Temperature Controlled Clinical
Materials
B: Selecting the Correct Outsourced Partners and Building the Right Relationship for
Effective Vendor Management
C: Innovations in Clinical Trial Supplies Labelling and Packaging
See inside for more details and package discounts…
“Very valuable,
inspired.”
Novartis AG
Expert advisory panel:
Tony Street, Worldwide Director Clinical Trial Supplies,
Allergan
Amandeep Madra, Director, Supply Chain Logistics,
GlaxoSmithKline
Juergen Rapp, Global Head, Supply Planning, Novartis
Robert Smith, QP and Director, Clinical Pharmacy
Research Services, Genzyme
Engage with 30 industry speakers including:
Ian Holloway, Manager, Defective Medicines Centre,
MHRA, UK
Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG
USA Branch, PDA
Kim Tang Hvistendal, Director, Clinical Supply,
LifeCycle Pharma
Gary Cunnington, Global Head, Clinical Trial Supply,
Respiratory, Boehringer Ingelheim
Dorthe Lerche Berg, Head of Department, Clinical Supply
Coordination, Lundbeck
Danny Raymakers, Head of Supply Chain Management,
Clinical Supply Management, Johnson & Johnson
Bernadette Cunningham, Director, Pharmaceutical
Operations, OSI Pharmaceuticals
Trevor Knott, Associate Director Clinical Supplies,
Scientific and Operational Clinical Support, Eisai Ltd
Dr Almut Malone, Global Logistics Clinical Supplies,
Bayer Schering Pharma AG
Bernd Schaden, Clinical Supply Chain Manager, Global
Supply Chain, Baxter Innovations GmbH
Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm
Solutions & Chair, Global Clinical Supplies Group, Inc.
Mark Harmer, Global Clinical Supplies Operations
Manager, Merck, Sharp and Dohme
Alfredo D’Addio, Strategic Planner, Global Investigational
Material Supply Chain, Celgene Corporation
see inside for more speakers…
Introducing Europe’s largest and most
prestigious clinical trial supply speaker panel
Sponsors & Exhibitors

Clinical Trial Supply Europe Speaker Panel
Tony Street,
Worldwide Director Clinical Trial Supplies,
Allergan
Amandeep Madra,
Director, Supply Chain Logistics,
GlaxoSmithKline
Juergen Rapp,
Global Head, Supply Planning,
Novartis
Robert Smith,
QP and Director, Clinical Pharmacy Research Services,
Genzyme
With Special Thanks To Our Executive Advisory Board:
Your Distinguished Speaker Faculty
Ian Holloway, Manager, Defective
Medicines Centre, MHRA, UK
Dr Rafik H. Bishara, Technical Advisor
and Chair PCCIG USA Branch, PDA
Amandeep Madra, Supply Chain
Director, GlaxoSmithKline
Juergen Rapp, Global Head Supply
Planning, Novartis
Alfredo D’Addio, Strategic Planner,
Global Investigational Material Supply
Chain, Celgene Corporation
Danny Raymakers, Head of Supply
Chain Management, Clinical Supply
Management, Johnson & Johnson
Bernadette Cunningham,
Director, Pharmaceutical Operations,
OSI Pharmaceuticals
Trevor Knott, Associate Director
Clinical Supplies, Scientific and
Operational Clinical Support, Eisai Ltd
Annegret Van der Aa,
Clinical Trial Manager,
Galapagos NV
Bernd Schaden, Clinical Supply Chain
Manager, Global Supply Chain,
Baxter Innovations GmbH
Steven A. Jacobs, MBA, R.Ph.,
President, Global BioPharm Solutions
& Chair, Global Clinical Supplies
Group, Inc.
Mark Harmer, Global Clinical
Supplies Operations Manager,
Merck, Sharp and Dohme
Vivek Peshkar, Senior Drug Supply
Management, Supply Planning and
Design, Novartis
Uffe Larsen, Team Leader, Clinical
Supplies, Novo Nordisk
Dorthe Lerche Berg, Head Of
Department, Clinical Supply
Coordination, Lundbeck
Gary Cunnington, Global Head,
Clinical Trial Supply, Respiratory,
Boehringer Ingelheim
Dr Almut Malone,
Global Logistics Clinical Supplies,
Bent Christensen, Team Leader,
Clinical Trial Supply, Novo Nordisk
Kim Tang Hvistendal,
Director, Clinical Supply,
LifeCycle Pharma
Steve Benson,
Supply Chain Systems Manager,
GlaxoSmithKline
Lorna Briddick, Global Clinical
Supplies Regional Lead, Latin
America, Merck
Steve Healy, Sales and Marketing
Manager, SCA Cool Logistics
Christian Knoblich, Commercial
Director, Movianto Group
Tony Moult, Proprietor,
A.N. Moult Consultancy Services
Sam Corveleyn, Director, CMC and QP,
ActoGeniX N.V.
Marianne Veighey, Team Manager,
Supply Chain, Astrazeneca
Dr Riekert Bruinink, Chairman, PIC/S
GDP Working Group, Member of
the EMEA GDP Drafting Group, Dutch
Healthcare Inspectorate
Justin Doel, Head, Global Clinical
Supplies, Novartis Vaccines
Dear Colleague,
I wanted to take this opportunity to welcome you officially to Pharma IQ’s Clinical Trial Supply Europe Conference. In an era of cost cuts and lean
processes, the clinical trials supply network had come under an increased amount of scrutiny to cut overages, cut costs and increase flexibility.
Along with the executive advisory board and speakers, we have developed the most time specific and relevant agenda for clinical trial supply professionals,
providing 3 days of new presentations, exclusive interactive discussion sessions and countless networking opportunities to provide you with the tools to
become fitter, faster and drive the critical transformation you need in 2011
“Only 13 percent of clinical trial material shipments arrived on time and, even then, 1 in 10 were incomplete”
Survey cited by Fisher Clinical Services White Paper 2010
I came across this quote whilst conducting agenda research and I’m sure you’ll agree, it really sums up the challenge this area is currently facing – the challenge
you are facing.
I invite you to join us at the conference in January and start actively ticking off the major things on your clinical trial supply to do list for 2011.
The speakers, sponsors and advisory board look forward to seeing you next January in Rotterdam for the Clinical Trial Supply Europe Conference.
Kind Regards,
Nichola Welch
Senior Conference Director, Pharma IQ (a division of IQPC)
“I have to say that the agenda looks
really exciting with many relevant
sessions that relate to our daily work”
Kim Tang Hvistendal, Lifecycle Pharma A/S

PRE-CONFERENCE SPECIALIST DISCUSSIONS: Wednesday 26TH JANUARY 2011
Specialist Discussion Forum A: 09.00 – 12.00
Developing a Robust and Compliant Process for
Temperature Controlled Clinical Materials
In this interactive discussion you will join fellow professionals
charged with supplying temperature controlled clinical materials.
With the multitude of challenges that can occur when working
with this type of product, it is essential that you have a clear
programme in place to maintain an effective temperature
controlled supply for your clinical materials.
This workshop will discuss:
1. Effective assessment techniques of any logistics
challenges when establishing a temperature controlled
distribution to depots and clinical sites
• Different ranges of conditions - deep frozen, frozen,
refrigerated and other needs
• Active systems
• Passive systems
2. Understanding and managing risk
• Rate of failure
• Real product risks
• Patient treatment risks
• Financial risk
• Administrative and inter-departmental expectation risks
3. QA for temperature sensitive materials both in transit and
during storage at the clinical site
• Use of temperature monitors
• Obtaining data from clinical sites
• Timely review of data
• Handling of temperature excursions
•Administrative
•Minor
•Major
• Problem identification, elimination and process improvement
4. Stability issues
• Ensuring stability during storage and transit
5. Temperature controlled supply in emerging markets
Discussion Facilitator:
Tony Moult, Proprietor, A.N. Moult Consultancy Services
Specialist Discussion Forum B: 12.30 – 15.30
Innovations in Clinical Trial Supplies Labelling
and Packaging
In this peer-to-peer focused discussion group, attendees will
explore the latest packaging and labelling technologies available
and understand how these can be applied in different countries
and situations.
You will also discuss the latest regulatory hurdles to be aware of
and how these can and do differ from country to country.
Specialist Discussion Forum C: 16.30 – 19.30
Selecting the Correct Outsourced Partners and
Building the Right Relationship for Effective
Vendor Management
In this hands-on workshop, attendees will get the chance to
discuss tried and tested best practices when it comes to selecting
and managing outsourced partners. It is crucial to keep these
relationships working fluidly as a part of your supply chain to
ensure consistent supply for clinical trials. Topics to be discussed
include:
• Sourcing and selection strategies that work
• Building the relationship and establishing roles and
responsibilities one each side
• The challenges that can arise and how you can navigate
past them
• Case studies to work through in smaller groups
Discussion Facilitator:
Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm
Solutions and Chair, Global Clinical Supplies Group, Inc.

PRE-CONFERENCE FOCUS DAY: Wednesday 26TH JANUARY 2011
Clinical Trial Supply Leaders Focus Day: Strictly No Presentations
09.25 Pharma IQ Welcome and Chair’s Opening Remark’s
09.30 Efficiently Selecting and Managing a Global Clinical Supply Team:
The Ingredients of a Successful Team
• How to ensure you have the right team in place for the job in hand
• Evaluating the different management structures you can adopt to
manage a global network effectively
• Assessing which one will work for your company
Juergen Rapp, Global Head, Supply Planning, Novartis
10.20 Understanding the Behavioural Traits and Styles of Your Business
Partners to Really Make The Relationship Work
• What drives your business partners and how can you align this with
your own goals?
• Ensuring you have the correct personalities on both sides to work as
one team
• Negotiating other barriers such as time, culture and language
Trevor Knott, Associate Director Clinical Supplies, Scientific and
Operational Clinical Support, Eisai Ltd
11.10 Networking Coffee Break
11.30 Benchmarking Performance Measures for External Partners
• What are the best metrics you can use to assess and compare current
partners?
• how this can be effectivelytranslated to enhance partner performance
• Specific experience from all attendees and discussion on best practice
Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline
12.20 Networking Lunch Break
13.10 Creating a Clinical Trial Supply Network to Support New Initiatives
Such as Adaptive Trials
• Understanding where the complications come with innovations in trial
formats when supply is needed
• How to ensure you have a platform ready to facilitate these trial types
effectively
• Sharing of specific experiences and lessons learned
Danny Raymakers, Head of Supply Chain Management, Clinical Supply
14.00 Effectively Enhancing Your Distribution Practices Through Resource
Pooling
• Understanding the business benefits of pooling resources for
distribution
• The practicalities of changing your distribution to this formula: the
planning process and what successful implementation looks like
• Discussion of other experiences moving to a pooled resources model
Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory,
15.10 Successful Interface Management For Clinical Trial Supplies
• Understanding the challenges that can arise with managing multiple
interfaces
• Where, as senior manager, can you plan for and manage this?
Dr Almut Malone, Global Logistics, Clinical Supplies, Bayer Pharma AG
16.00 Close of Clinical Trial Supply Leaders Focus Day
Pharma IQ’s Clinical Trial Supply Leaders Focus Day delivers a unique opportunity that will go past the tools and techniques to discuss how you,
as a business leader, can truly enable and embed key strategies into your clinical trial supply operations and build a culture that drives the critical
transformation you need during 2011.
Through a leader-to-leader debate driven format, you’ll be able to address your most critical clinical trial supply challenges from a director level,
ensuring you leave with solutions tailored to your development needs.
The focus day agenda is constructed to help make sure your clinical trial supply chain business is ready to excel in 2011 by becoming fitter, faster and
more cost effective.
Here’s how:
All this makes the Clinical Trial Supply Leaders Focus Day an unmissable chance
to benchmark your supply networks and strategies against others and strengthen
your development plan for the year ahead.
N.B You will be asked to share your own experiences during the focus day to make
this truly interactive. So come ready to SHARE!
1. First of all you’ll find no
standard presentations, no
self publicity - only complete
information sharing and
genuine discussion between
pharmaceutical and
biotechnology clinical trial
supply directors
2. Each discussion is led by
a different leader to reflect
the different approaches to
clinical trial supply across real
organisations today, making it
the perfect chance to compare
and contrast theory in practice
3. You can submit your key
challenges and requests for
discussion to the group ahead
of time by sending them to
nichola.welch@iqpc.co.uk
4. You’ll find no sales pitches
– strictly business-to-business
knowledge sharing

CONFERENCE DAY ONE: THURSDAY 27TH JANUARY 2011
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07.45 Coffee and Registration
09.00 Pharma IQ Welcome and Chair’s Opening Address
Ensuring Complete Compliance With Regulatory Bodies Across Europe
09.10 Regulatory Update: Regulatory Views and Concerns for Clinical
Supplies
• Annex 13 then and now: how will the recent changes affect you?
• Improvements to the Clinical Trials Directive and related legislation:
expectations and impact
• Defects, recalls and quality system problems: preparing and considering in
advance
Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK
Reacting to a Cost Driven Environment by Effectively Building
Efficiencies into Your Clinical Supply Network
09.50 Case Study: How to Establish a Demand and Operations Planning
Process in the Clinical Supply Chain
(using risk based forecasting and planning in a clinical trials supply chain)
• The benefits of using an S&OP process drawn from a commercial supply
chain in a clinical trial supply chain
• Discussion of the strategy employed and the different phases of execution
• The impact upon business processes, information systems and ways of
working
• How was the risk mitigated in this to ensure supply was not disrupted?
• Managing the change process across the R&D supply chain
• A case study (project example) and the lessons learned
Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline
10.20 Successfully Adapting Proven Logistics and Distribution Models
to Your Clinical Trials Supply Chain
• Developing a secure strategy for temperature controlled storage and
distribution
• Working with 3rd parties to establish uninterrupted supply of clinical trial
materials
• Solutions for labelling and packaging
• The importance of effective returns management in a clinical supply network
• Discussion of case study examples
Christian Knoblich, Commercial Director, Movianto Group
Supporting Emerging Clinical Trial Models and Integrating
Supply Chains Effectively
11.10 Case Study: Supporting Emerging Trends of Adaptive Design with
Clinical Supply
• Adaptive design studies and benefits to clinical development
• Overcoming the challenges forecasting and simulation pose
• Challenges to the clinical supply chain: design feasibility (blinding, schedule
management and IVRS)
• Project team structures that deliver success for adaptive designs
Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp
and Dohme
11.40 Case Study: Developing an Integrated Supply Chain By
Implementing Supply Chain Management Frameworks
• Discussion of the benefits of applying a planning framework to your clinical
supplies
• What different planning methods are available when looking at aspects such
as quality vs. cost and waste management?
• The automated systems that are available to support this
Danny Raymakers, Head of Supply Chain Management, Clinical Supply
12.10 Spotlight Session
This session will be dedicated to a leading service provider from within the
clinical trial supply arena, offering you the opportunity to hear first-hand
how the latest technology innovations could help you reach your CSM goals
in 2011.
14.15 Interactive Roundtable Discussion
This is your chance to discuss key topics and challenges in
smaller groups. Attendees will be able to share their own experiences
and hear those of others, exchange ideas and get clear answers to specific
questions. So, in order to make the most of these interactive sessions,
participants should come armed and ready to share their own experiences
and have clear questions they need answers to.
Choose from one of the following:
A: Ensuring Clinical Trial Supplies Success in Emerging Markets
Attendees will share their experience of working in emerging markets; the main
challenges that arise and each person’s approach to overcoming them.
Annegret Van der Aa, Clinical Trial Manager, Galapagos NV
B: Ensuring Successful Temperature Controlled Supply of Clinical
Materials
This roundtable will focus on how to establish and manage a cool chain specifically
for temperature sensitive clinical materials effectively. The pitfalls to try and
avoid, the regulations to comply with and how to make this as green and cost
efficient as possible.
Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA
C: Innovation in Packaging and Labelling
This roundtable will allow attendees to discuss the key regulations within
packaging and label design that must be taken into account as well as new
technologies that may be able to help with challenging areas such as blind and
double blind trials and adaptive trials.
•Automation in packaging
•Green packaging innovations
Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination, Lundbeck
D: Successful Strategies For Working With Comparator and Global Trials
When working with comparators, there is always the uncertainty or ensuring
consistent supply and product quality. This roundtable will discuss how you can
mitigate against the risks here and ensure the trial is never stalled on account of
supply stock-out on the comparator side.
Bernd Schaden, Clinical Supplies Manager, Baxter
E: Maintaining Compliance with cGDP and cGCP Regulations
This roundtable will allow attendees to focus not only on the regulations
themselves, but also the sticking points that can sometimes leave a company
vulnerable to non-compliance. How can you avoid this?
Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK
F: Transport and Customs Challenges for Clinical Supplies
This roundtable will look to discuss the challenges that arise with getting
investigational materials and in and out of countries as well as looking at specific
countries where this proves more of a challenge. Participants will also be asked to
share their own experiences.
Steven A. Jacobs, President, Global BioPharm Solutions, LLC, Chair,
Global Clinical Supplies Group, Inc.
G: Partnering with Vendors to Ensure Quality and On Time Delivery
The reliance on 3rd party suppliers and logistics providers is high in any clinical
supply network and it is always difficult to manage multiple parties to ensure
complete alignment. This roundtable will focus on best practice approaches to
managing this network effectively and make sure no costly slip-ups occur.
Bernadette Cunningham, Director, Pharmaceutical Operations,
OSI Pharmaceuticals
H: Removal of Expiry Dates From Investigational Material Labels in
Europe
With the gap now closing on turning concept to reality, it is important to start
looking internally at how your company is fixed to support this industry shift.
This roundtable will discuss the recent experiences of those who have piloted the
removal of expiry dates from labels. The lessons learned and how you can move
forward in your own company.
Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk
I: Clinical Trial Supply for In-License Products
This roundtable will the challenges that arise with clinical trial supplies for
in-licensed products, the main hurdles you have to overcome and how to do this.
Participants will share their experience and potential strategies to move forward.
Marianne Veighey, Team Manager, Supply Chain, Astrazeneca
REGULATORY
UPDATE

15.00 Case Study: Successfully Developing Clinical Material Resource
Pooling Into Your Distribution Strategy
• Fully understanding the rationale behind adopting this method of storage
and distribution
• Highlighting the challenges that were and are being faced with the change
of structure
• What are the realised costs and business benefits for the venture and
what are the next steps?
15.30 Developing Temperature Controlled Packaging for Effective
Distribution in Regional and Global Clinical Trials?
• Innovative technology
• Fit for purpose: designing packaging solutions to meet specific criteria and
certain temperature ranges
• Totalcostofownership:calculatingthepackagingcostperlitervolumeshipped
• Assessing sustainability initiatives for today’s temperature control
shipping of pharmaceuticals
Steve Healy, Sales and Marketing Manager, SCA Cool Logistics
Stream A: Ensuring Product Integrity By Designing and
Executing a Successful Temperature Controlled Network for
Clinical Supplies
Stream Chair: Rafik H. Bishara,
PhD, Technical Advisor and Chair PCCIG USA Branch, PDA
Stream B: Enabling Faster Distribution By Developing a More
Flexible Clinical Distribution Network
Stream Chair: Dr Almut Malone, Global Logistics Clinical Supplies,
16.30 Regulatory Update: Developments in Good Distribution Practice
Regulations and the Impact on Clinical Supplies
• Outlining the new GDP regulations in general
• Evaluating the key changes in the GDP guidelines within the EU and how
these have/will affect clinical supply
• Understanding any key temperature control aspects that need to be
taken into consideration for cool chain products.
• Implementation of revised GDP guidelines
Dr Riekert Bruinink, Chairman, PIC/S GDP Working Group, Member of the
EMEA GDP Drafting Group, Dutch Healthcare Inspectorate
17.00 Case Study: Successfully Developing Predominately Airborne
Clinical Trial Shipping Programme
• Understanding the drivers behind the use of air transport rather than
land
• Using airborne supply networks to reduce the risks in customs hold ups
and temperature deviations
• Establishing clear, accountable KPI’s with your partners to ensure high
quality and timely supply
Bent Christensen, Team Leader, Clinical Trial Supply, Novo Nordisk
17.30 Case Study: Managing the Interface in Distribution of Clinical
Supplies
See www.clinicalsupplyeurope.com for updates
Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering
Pharma AG
16.30 Ensuring Compliance with Global Requirements for the Storage
and Distribution of Temperature Sensitive Clinical Materials
• Examining industry trends in global clinical trials and their impact on
distribution chains and processes
• Best practices for frozen and refrigerated shipments
• Labelling and documentation for return samples to labs from international
clinical trials
• Effective tracking and monitoring of investigational materials
• Developing a system for Good Cold Chain Management practices for
clinical supplies within your company
Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA
17.00 Case Study: Assessing and Selecting Sub-Contractors for
Packaging, Labelling and Clinical “Cold Chain” Supply
• Setting up packaging and distribution processes, KPIs and metrics with
partners
• Audit frequency and schedule
• Deciding best practice for packaging temperature sensitive IMPs,
temperature monitoring and reporting procedures
• A QP point of view: temperature excursions and keeping partners
accountable and IMPs safe for administration
• Implementing continuous long-term improvements with partners
Sam Corveleyn, Director, CMC and QP, ActoGeniX N.V.
17.30 Open Discussion: Implementing New Temperature Monitoring
Processes and Technologies to Avoid Lost Investigational Materials
• Discussion of the different technologies currently available
• Integrating these into your current strategies
• Ensuring compliance with the regulations
Conference Day One Speakers and Steam A attendees are invited to join this
discussion
18.00 Chair’s Closing Remarks and End of Day One
18.15 Networking Drinks Reception in the Exhibition Hall
19.30 Gala Dinner and Pharma IQ Clinical Trial Supply Award
After a full first day of discussion and idea sharing, join your peers in this ultimate networking occasion.
Sit back, relax and enjoy a sumptuous 3 course meal with wine, talk over the topics of the day and take this
opportunity to really get to know your fellow delegates and increase your network of contacts in the area.
Pharma IQ Clinical Trial Supply Award also offers a great opportunity for you to recognise excellence within
the industry. See www.clinicalsupplyeurope.com. for more information on how to nominate your project
of the year!
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“Very valuable.”
Marco Luyten, Kerry Logistics
Pharma IQ event attendee
Claim your free Kindle, iPod Nano or €100 Amazon Vouchers!
Early Booking Treats: Book and pay by 8th October 2010 and receive an IQ Treat!
Pick your treat from the options below:
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REGULATORY
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REGULATORY
UPDATE

CONFERENCE DAY TWO: FRIDAY 28TH JANUARY 2011
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07.45 Coffee and Registration
08.20 Chair’s Opening Remarks
Establishing Multiple Supply Networks and Moving Your Business
Closer to Removing Expiry Dates from Labels in the EU Using IRT
08.30 Case Study: Let’s Start Six Global Phase III Trials in One Year!
• Generating a global booklet label to support multiple clinical trials
• Create a supply strategy that can supply all six trials effectively: outlining
the challenges and the answers
• How to program the IVRS (one massive system or multiple individual)
Alfredo D’Addio, Strategic Planner, Global Investigational Material Supply
Chain, Celgene Corporation
09.10 Panel Discussion: Removing Expiry Dates from CMP
Labelling: The Business Benefits and the Challenges
• Discussion surrounding the rationale behind moving towards the removal
of expiry dates from CTM labels and what the true benefits will be
• What are the perceived challenges and how do these match to the actual
challenges seen by the ISPE/PDA task force?
• What are the next steps to be taken by the industry to ensure this is fully
adopted and realised?
Panelists Include:
Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk
09.40 Case Study: Innovative Approaches to Increasing Efficiency by
Maximising the Potential of Your Interactive Response
Technology (IRT)
• How to incorporate IVR and IWR systems into your current supply chain
• Managing the expectations of this technology with the reality of delivery
• Discussions as to how IRT data and system has helped control supply levels
• Maximising benefits of systems through integration of information
Steve Benson, Supply Chain Systems Director, GlaxoSmithKline
10.40 Interactive Crisis Management: Ensuring Your
Clinical Supplies Still Make It!
Unexpected challenges can arise anywhere, anytime, leaving you very
little time to prepare and regroup. This dedicated, interactive session will
see attendees divided into small groups and given a “disaster scenario”
to work through. Your task, as a team, is to devise a strategy to ensure
your clinical supplies arrive at their required destination with as little
disturbance as possible.
Group Leaders will be:
A. Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination,
Lundbeck
B. Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp
and Dohme
C. Bernadette Cunningham, Director, Pharmaceutical Operations,OSI
Pharmaceuticals
D. Tony Moult, Proprietor A.N. Moult Consultancy Services
E: Steven A. Jacobs, President, Global BioPharm Solutions, LLC, Chair,
Global Clinical Supplies Group, Inc.
F: Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma
G: Justin Doel, Head, Global Clinical Supplies, Novartis Vaccines
11.40 Case Study: Demand Driven Supply of IP: Creating Flexibility and
Cutting Cost in an Established Clinical Supply Network
• Analysis of the problems that needed to be addressed
• Discussion of the strategy employed and the different phases of execution
• How was the risk mitigated in this to ensure supply was not disrupted?
• What are the benefits that have been seen and the lessons learned
Vivek Peshkar, Senior Drug Supply Management, Supply Planning and
Design, Novartis
Effectively Planning for the Challenges that Occur When
Working With Comparator Studies
13.30 Spotlight Session
This session will be dedicated to a leading service provider from within the
Comparator Sourcing arena, offering you the opportunity to hear first-hand
the latest strategies in comparator sourcing.
14.00 Panel Discussion: Overcoming Challenges With
Comparator Sourcing and Comparator Consistency
for Global Clinical Trials
• The benefits and drawbacks of key strategies that can help ensure
consistent supply of comparators
• Central vs. local sourcing: which is the right path to choose and why?
• Are there factors that can change the answer?
• Understanding the regulations surrounding comparator sourcing and
packaging
Bernd Schaden, Clinical Supplies Manager, Baxter
Lorna Briddick, Global Clinical Supplies Regional Lead, Latin America, Merck
Establishing a Robust Clinical Supply Network in Emerging Markets
and Effectively Working with External Partners
14.30 Case Study: Planning and Executing Effective Clinical Trial Supply
in Eastern European Countries: The Small Company Perspective
• Outline of the rationale behind working in Eastern European Countries
• Discussion of the planning phase: approach and challenges
• Experience and hurdles so far?
• Relationship management strategies that ensure you work with your
partners as a cohesive team
• What are the lessons learned?
15.30 Case Study: Successful Delivery and Management of Clinical
Supplies for Latin America
•Latin America’s importance in the future of pharmaceutical clinical trials
•Introduction of Clinical Supplies Regional Lead Role
•The importance of establishing a robust supply network to support clinical
trials in Latin America
•Highlights of some key challenges and opportunities with Latin American
countries
•Discussion of specific cases and the lessons learned
Lorna Briddick, Global Clinical Supply Regional Lead, Latin America, Merck
16.00 Panel Discussion: Effectively Selecting and Working
With External Partners
• Best practice approaches to selecting a partner
• Understanding the key drivers when outsourcing on both sides as the key
to creating a working partnership: how can you ensure you have all of this
information?
• Developing the relationship: how can you effectively develop a strong
relationship with a partner and use this effectively?
Vivek Peshkar, Senior Drug Supply Management, Supply Planning and
Design, Novartis
Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma
16.30 Chairperson’s Closing Remarks and Close of Conference
Register and Pay Before the 24th
September and Save up to €1,797!
Limited to the first 20 registrants!

About the event
Join your peers at one of a number of networking events at
Pharma IQ’s Clinical Trial Supply Europe Conference
Who will be at Pharma IQ’s Clinical Trial Supply Europe Conference?
Get ready for 3 full days of targeted discussion and networking in one of the many dedicated sessions where you can exchange
ideas on specific aspects of clinical trial supply, increase your network of professionals in the area and just get to know people.
This will build up to an evening drinks reception and gala dinner at the end of conference day one, where you can enjoy a glass of
wine, dinner and the chance to relax with your peers.
Pharmaceutical 50
Biotech 10
CRO’s 10
Suppliers 30
Industry Areas
Germany 20
UK 20
Belgium 10
France 10
Denmark 10
Austria 10
Switzerland 10
Other 10
Geo BreakdownJob Function
Clinical Trial supply 60
Logistics 10
Clinical Project Manager 5
Clinical Operations 5
Business Development and Marketing 25
What’s new, what’s different?
• Quality: 30 high level speaker programme from large and small pharma companies and new
speakers to boot. We have gone out of our way to ensure you are able to listen to, and learn
from as many, highly qualified clinical trial supply professionals as possible, giving you a prime
opportunity to take home a number of new strategies and innovations to employ at your company
• Seniority: Our Pre-Conference Clinical Trial Supply Leaders Focus Day will provide a unique,
leader-to-leader, debate driven format with no presentations. An ideal opportunity to
discuss on a professional level with the leaders of CTS
• Tailored streams: Delivering not only the option for attendees to tailor their event, but also a
chance to really focus down on your key initiatives for 2011
• High levels of interaction and networking: A key theme that runs through all IQPC
conferences, we have set aside time for a variety of networking and focused discussion
throughout the two days including, roundtables, panels, interactive crisis management session,
drinks reception and gala dinner
“It addressed a number of key
issues of relevance and had a
good balance of topics.
A valuable meeting.”
Paul Briner, Prosidion Ltd

Sponsorship and Exhibition Opportunities
Maximise Your Involvement: Sponsorship and Exhibition Opportunities
Pharma IQ’s Clinical Trial Supply Europe Conference will be attended by
senior officials and decision-makers from industry, bringing together buyers
and suppliers in one location. Focused and high-level, the event will be an
excellent platform to initiate new business relationships. With tailored networking,
sponsors can achieve the face-to-face contact that overcrowded trade shows
cannot deliver.
Exhibiting and Sponsorship options are extensive, and packages can be
tailor-made to suit your individual company’s needs. Most packages include
complimentary entry passes, targeted marketing to industry officials and
executives, and bespoke networking opportunities.
Other features of sponsorship include:
• Prominent exhibition space in the main conference networking area
• Participation in comprehensive pre-event marketing campaigns
• Tailored marketing strategies to suit your organisation’s size, capabilities and
individual requirement
For more information and to discuss the right opportunity, contact
Gal Cohen on +44 (0)207 368 9300 or sponsorship@iqpc.co.uk
Sponsors and Exhibitors
Web: www.movianto.com
Tel: +49 (0)711 900 597 900
Fax: +49 (0)711 900 597 910
Email: contact@movianto.com
Gold Exhibitor
Session Sponsor Featured Exhibitors
Web: www.worldcourier.com
Tel: +32 2 712 50 80
Email: sales@worldcourier.com
Web: www.topa.nl
Tel: +31 (0)252 245 256
Fax: +31 (0)252 245 257
Email: info@topa.nl
Web: www.almacgroup.com
Tel: +44 28 3836 2436
Fax: +44 28 3836 3800
Email: clinicalservices@almacgroup.com
Web: www.elpro.com
www.pdf-datalogger.com
Tel: +41 82 750 03 11
Email: swiss@elpro.com
Web: www.sca-cool-logistics.com
www.zeocool.com
Tel: +44 (0)1525 243770
Fax: +44 (0)1525 243779
Email: cool.info@sca.com
Media Partners
About Pharma IQ
Become a member of Pharma IQ and receive complimentary access to Resources that will keep you at the forefront of industry change.
You will receive access to our growing library of multi-media presentations from industry leaders, an email newsletter updating you on new content that has
been added, free aggregated news feed from over 1000 global news sources tracking your industry and special member only discounts on events.
Become a member here: www.pharmaceuticaliq.com/IQLogin.aspx?IQ=pharma
“Very good mixture of different
aspects, interesting case studies.”
Rene Brecht, ProBioGen AG

5 WAYS TO REGISTER
Freephone: 0800 652 2363 or
+44 (0)20 7368 9300
Fax: +44 (0)20 7368 9301
Post: your booking form to
IQPC Ltd. Anchor House,
15-19 Britten Street,
London SW3 3QL
Online: www.clinicalsupplyeurope.com
Email: enquire@iqpc.co.uk
Conferencecode19291.001
PAYMENT MUST BE RECEIVED PRIOR TO THE CONFERENCE
Please read the information listed below as each booking is subject to IQPC Ltd standard terms and conditions.
Payment Terms: Upon completion and return of the registration form full payment is required no later than 5
business days from the date of invoice. Payment of invoices by means other than by credit card, or purchase
order (UK Plc and UK government bodies only) will be subject to a €65 (plus VAT) per delegate processing fee.
Payment must be received prior to the conference date. We reserve the right to refuse admission to the confer-
ence if payment has not been received.
IQPC Cancellation, Postponement and Substitution Policy: You may substitute delegates at any time by
providing reasonable advance notice to IQPC.
For any cancellations received in writing not less than eight (8) days prior to the conference, you will receive a
90% credit to be used at another IQPC conference which must occur within one year from the date of issuance
of such credit. An administration fee of 10% of the contract fee will be retained by IQPC for all permitted
cancellations. No credit will be issued for any cancellations occurring within seven (7) days (inclusive) of the
conference.
In the event that IQPC cancels an event for any reason, you will receive a credit for 100% of the contract fee paid.
You may use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one
year from the date of cancellation.
In the event that IQPC postpones an event for any reason and the delegate is unable or unwilling to attend in
on the rescheduled date, you will receive a credit for 100% of the contract fee paid. You may use this credit
for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of
postponement.
Except as specified above, no credits will be issued for cancellations. There are no refunds given under any
circumstances.
IQPC is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postpone-
ment of an event. IQPC shall assume no liability whatsoever in the event this conference is cancelled, resched-
uled or postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders
performance of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous
event shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency.
Please note that while speakers and topics were confirmed at the time of publishing, circumstances beyond the
control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics.
As such, IQPC reserves the right to alter or modify the advertised speakers and/or topics if necessary without any
liability to you whatsoever. Any substitutions or alterations will be updated on our web page as soon as possible.
Discounts
All ‘Early Bird’ Discounts require payment at time of registration and before the cut-off date in order to receive
any discount. Any discounts offered whether by IQPC (including team discounts) must also require payment at
the time of registration. All discount offers cannot be combined with any other offer
6 Please do not pass my information to any third party
Terms and Conditions
IQPC recognises the value of learning in teams. Groups of 3 or more
booking at the same time from the same company receive a 10%
discount. 5 or more receive a 15% discount. 7 receive a 20% discount.
Only one discount available per person.
Team Discounts*
VENUE:
World Trade Centre, Rotterdam, The Netherlands
Beurs-WTC, Beursplein 37, P.O. Box 30099, 3001 DB ROTTERDAM
Telephone: +31 10 405 44 44, Fax: +31 10 405 50 16
E-mail: info@wtcro.nl, Website: www.wtcrotterdam.nl
ACCOMMODATION:
Accommodation is not included in the registration fee.
For accommodation please search
http://www.4cityhotels.com/rotterdam.html
Venue & Accommodation
To claim a variety of articles, podcasts and other free resources please
visit www.clinicalsupplyeurope.com
Free Online Resources
A digital version of the conference proceedings, including all
presentations, is available to buy. 
6 I cannot attend the event, please send me the CD Rom priced at
£599 plus VAT
Recent digital conferences available - £599 plus VAT each
6 Cool Chain Europe 2010/11
6 Pharma Distribution Sept 2010
6 Pharmaceutical Serialisation and Traceability, November 2010
6 Global Clinical Outsourcing Forum, May 2010
6 Please send me conference materials indicated above.
6 I have filled out credit card details below
For further information
Please call: 0207 368 9300
or email: knowledgebank@iqpc.co.uk.
To search IQPC’s archived conference documentation
visit: www.iqpcknowledgebank.com
Digital Conference On CD-ROM
Total price for your Organisation: (Add total of all individuals attending):
Card Number: VISA 6 M/C 6 AMEX 6
6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6
Exp. Date: 6 6 6 6 Sec: 6 6 6 6
Name On Card: Signature:
Billing Address (if different from below):
City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.)
(Please quote 19291.001 with remittance advice)
IQPC Bank details: HSBC Bank, 67 George Street, Richmond, Surrey, TW9 1HG. United Kingdom.
Sort Code: 40 05 15, Account No: 59090618, IBAN Code: GB98 MIDL 4005 1559 0906 18
Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd.
Please photocopy for each additional delegate
6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other
First Name Family Name
Job Title Tel No.
Email
6 Yes I would like to receive information about products and services via email
Organisation
Nature of business
Address
Postcode Country
Telephone Fax
Approving Manager
Name of person completing form if different from delegate:
Signature
I agree to IQPC’s cancellation, substitution and payment terms
Special dietary requirements: 6 Vegetarian 6 Non-dairy 6 Other (please specify)
Please indicate if you have already registered by Phone 6 Fax 6 Email 6 Web 6
Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking.
Delegate Details
Payment Method
Book and pay by 8th October 2010 and receive an IQ Treat! Pick your treat from the options below:
6 Kindle Wireless Reading Device, Wi-Fi, 6” Display, Graphite - Latest Generation
6 New Apple iPod nano with Camera 8GB (5th Generation) – Black
6 €100 Amazon Vouchers
* Tick this Box if you wish to opt out of Full Access to Conference Recordings (Reducing Price by €550) 6
** Please select choice of workshop A 6 B 6 C 6
*** To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not valid in
conjunction with any other offer. Dutch VAT is charged at 19% VAT registration #: 8078 84 728 B 01
•Tick this Box if you wish to opt out of the Gala Dinner (Reducing Price by €150) 6
† All Access Pass Limited to first 20 registrants from pharma or biotech companies before 8th October
Two Day Conference: 27th-28th January 2011
Pre-Conference Focus Day: 26th January 2011
Venue: World Trade Centre, Rotterdam, The Netherlands
Register and pay
by 17th December
2010***
Standard
Price
Register and pay
by 12th
November 2010***
Contact us on +44 (0) 207 368
9300 or enquire@iqpc.co.uk
to check
availability before 8th October
Register and pay
by 8th October
2010***
Register and pay
by 24th September
2010***
SAVE €1148
€3398 +VAT
SAVE €949
€3398 +VAT
SAVE €650
€3697 +VAT
SAVE €450
€3447 +VAT
SAVE €400
€3298 +VAT
SAVE €350
€2898 +VAT
SAVE €250
€2349 +VAT
SAVE €250
€1799 +VAT
SAVE €200
€1849 +VAT
SAVE €600
€3747 +VAT
SAVE €400
€3497 +VAT
SAVE €350
€3348 +VAT
SAVE €300
€2948 +VAT
SAVE €200
€2399 +VAT
SAVE €500
€3847 +VAT
SAVE €300
€3597 +VAT
SAVE €250
€3448 +VAT
SAVE €200
€3048 +VAT
€2599 +VAT
€2049 +VAT
€1099 +VAT
€649 +VAT
€4347 +VAT
€4546 +VAT
€4347 +VAT
€3897 +VAT
€3698 +VAT
€3248 +VAT
SAVE €1797
€2749 +VAT
SAVE €1598
€2749 +VAT
SAVE €700
€3647 +VAT
SAVE €500
€3397 +VAT
SAVE €450
€3248 +VAT
SAVE €400
€2848 +VAT
SAVE €300
€2299 +VAT
SAVE €300
€1749 +VAT
All Access Pass †: Option 1 Conf + 3
Workshops + Full Access to Conference
Recordings* +GalaDinner•
All Access Pass †: Option 2 Conf + Fo-
cus Day + Workshop C + Full Access to
ConferenceRecordings*+GalaDinner•
Conference + Focus Day and
Workshop C + Full Access to
Conference Recordings* + Gala Dinner•
Conference + 2 Workshops** + Full
Access to Conference Recordings* +
Gala Dinner•
Conference + Focus Day + Full Access
to Conference Recordings* + Gala
Dinner•
Conference + 1 Workshop** + Full
Access to Conference Recordings* +
Gala Dinner•
Conference + Full Access to Conference
Recordings* + Gala Dinner•
Conference Only + Gala Dinner•
Focus Day Only
Workshop Only**
To speed registration, please provide the priority code located on the mailing label or in the box below.
My registration code is B
Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the registration
code above to inform us of any changes or to remove your details.

Clinical Trial Supply Europe Conference

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