World-Class Supply – End-to-End
Effective Approaches to Optimising Drug Supply and Ensuring Security: Exploring Best Practices
in both Investigational Products and Commercial Supply Chains
13–14 June 2013
www.ISPE.org/2013-Supply-Chain-Eu-Conference
Crowne Plaza Prague
Koulova 15–16045 Prague, Czech Republic
Register Today!
Plenary Session featuring two Keynote Addresses!
Don’t miss the Regulatory Forum on the second day!
Keynote One: Responding to the Challenges for Highly
Responsive, Integrated Supply Chains
Roddy Martin, Senior Vice President Supply Chain,
Accenture, USA
FIVE European regulators will discuss GMP Guidelines and
upcoming Directives.
Bryan Wright, Session Chair, ISPE Regulatory Advisor
Tony Orme, Senior GDP Inspector, MHRA
Richard Andrews, Expert GMP / GDP Inspector, MHRA, UK
Brendan Cuddy, Scientific Administrator, EMA UK
Jason Wakelin-Smith, GCP Inspector, MHRA, UK
Dr M. Chiavoni. Unit of Prevention of Counterfeiting, Italian
Medicines Agency (AIFA)
Keynote Two: Strengthening the Supply Chain –
A Regulator’s View
You will get an Expert Inspector’s view on current
challenges for GMP
Richard Andrews, Expert GMP / GDP Inspector, MHRA, UK
Clinical Supply Chain Track Highlights
Commercial Supply Chain Track Highlights
> Key themes and their implications for IP professionals will be
explored in-depth. These include JIT labelling and pooling to
optimise the clinical supply chain, supply chain security and
recommendations for improving the management of supplies
from a clinical site perspective.
> Industry and regulatory experts will share and network with
delegates to maximise the learning experience.
> Status and initial findings of the ISPE IP COP survey on the
Patient Experiences with IP will be introduced during the event.
Supply Chain Integrity will be investigated, questioned and
discussed in this track. This track will focus on effective
supply chain management and will touch on several areas that
influence your company’s approach to managing your supply
chain effectively. These areas of interest cover:
Three separate workshop sessions will provide delegates with
the unique opportunity to attend in-depth discussion and best
practice sharing on:
• How Well Connected is the Pharmaceutical Supply Network?
Nick Davies, CEO & Principal Consultant, NDA Consultants
• IRT Standardisation from both a Sponsor and Site
Perspective
Nimer Yusef (Trial Brain), Michael Richter (Roche)
• Drug Pooling and QP Release: Case Study and Discussion
Henryk Junker (Allergan) , Massimo Eli (Merck and Co)
• Innovative Approaches to Improve Clinical Supply Chain for
Our Users – The Patients
Samantha Carmichael (NHS Scotland), Christine Milligan
• Use of English-Only Labels on Inner Packs
Hans Heesakkers (Accenture), Karen Gram (Novo Nordisk)
• Key Attributes of Simulation Tools
Damian McEntegart (Perceptives), Chedia Abdelkafi (UCB)
• Perils and Pitfalls of Comparator Supply
Julian Schulz, Associate Director Clinical Supplies, Takeda,
Robert Donnell, Head of Business Development, Durbin
• WHAT DOES GMP REALLY MEAN? The Focused Pursuit
of Meeting Regulatory Compliance Standards is really not
Good Enough
Brendan Cuddy, Scientific Administrator, EMA, UK
• Technology Transfer - A line of sight from R&D to cGMP
manufacturing
Solutions supporting dependable technology transfer processes
will be shared for comment and discussion
Paul Bird, Head of Development Engineering, Fujifilm
• Security in the Supply Chain
Gain insights into one company’s approach to ensuring security
throughout a global supply chain.
Tom Cochrane, Business Process Development Manager,
NAPP Pharmaceuticals
• TWO seminars on Track-and-Trace will offer you distinct
perspectives
• TWO sessions on Temperature Control. Discussions
surrounding solutions in cold chain management as well as
control equipment choice and good practices to make your
supply chain commercially viable and solid will be featured
• Delegates will gain insights into anti-counterfeiting issues,
packaging fraud, pharmacovigilance and effective recall
• You will gain insights into the preliminary results of the global
ISPE survey on Drug Shortages that will be presented during
the event.
www.ISPE.org/2013-Supply-Chain-Eu-Conference
World-Class Supply – End-to-End
13–14 June 2013
Effective Approaches to Optimising Drug Supply and Ensuring
Security: Exploring Best Practices in both Investigational Products
and Commercial Supply Chains
Crowne Plaza Prague
Prague, Czech Republic
Conference Fees
Early Bird – on or Before 27 May 2013
Member
€ 1,520
New Member € 1,739
Regular/Onsite – After 27 May 2013
Non-Member € 1,830 Member
€ 1,720
Committee
€ 940
New Member € 1,939
Academia/Young Professionals/
Emerging Economy
Non-Member € 2,040
Committee
€ 940
€ 1,020 Academia/Young Professionals/
Emerging Economy
€ 1,150
The Pharmaceutical Supply Chain is defined as the management
of product supply from raw material sourcing to active ingredient
manufacturing or sourcing through formulation, packaging and
distribution to the patient. It encompasses all related activities across
the product lifecycle including clinical supply, scale-up and transfer
as well as outsourcing and product discontinuation. A key
requirement is the safe and reliable supply of quality medicines
through a supply chain which is responsive to true demand and
understands the voice of the customer.
Receive One Complimentary Guide of Your
Choice!
This conference will provide insights into many of the critical-tosuccess factors, with a focus on how the industry can achieve
world-class performance levels, achieve transparency in the endto-end networks and deliver value to all stakeholders with which it
relates. The conference will achieve this by combining examples of
best practices both within the industry as well as from other relevant
sectors. It is also intended to include the latest updates and
perspectives from regulatory authorities.
www.ispe.org/2013-supply-chain-eu-conference
Choose an ISPE Guide (electronic download) of your choice.
ISPE Good Practice Guide:
• Comparator Management
• Project Management for the Pharmaceutical Industry
• Cold Chain Management
How to Register
Online: Visit our website:
World-Class Supply – End-to-End:
www.ispe.org/2013-supply-chain-eu-conference
Via Fax: Complete the Registration Form online and fax it to
+32-2-743-1584
Questions? Call ISPE Europe at +32-2-743-4422 or email us at
ISPEregistrations@associationhq.com
Who should attend?
This conference is directed to Supply Chain
Managers and Planners, Production Managers,
Quality Assurance and Quality Control Staff,
Engineering Staff, Procurement Professionals,
Logistics Specialists, IP Professionals, Clinical
Quality Professionals, Clinical Research/Clinical
Operations Professionals, Regulatory Professionals
as well as all others with an interest in getting
a better understanding of the key issues and
developments in the pharmaceutical supply chain.
Written confirmation will be sent to you after your registration is
processed. For more information, visit the event website.
Hotel Information
Visit the conference event website to book the Crowne Plaza Hotel:
www.ispe.org/2013-supply-chain-eu-conference/hotel-and-travel
Standard Room: €120
Superior Room: €140
Prices mentioned above are quoted per room, per night and include taxes, service charges and buffet
breakfast, but exclude 14% VAT
Save the Date for Future Events in Europe
Conferences
Training
September 2013
September 2013
The Future of European Pharma
Flexible, Agile and Sustainable
30 September – 1 October
Brussels, Belgium
GAMP® 5 Training Course (T45)
Including Revised Annex 11 and
Part 11 Update
30 September – 2 October
Brussels, Belgium
October 2013
Operational Excellence
Conference,
17–18 October
Berlin, Germany
November 2013
Biotechnology Conference,
13–14 November
Strasbourg, France
www.ISPE.org/2013-Supply-Chain-Eu-Conference
October 2013
Prague Training Courses,
7–8 October
Prague, Czech Republic