ISPE 2012
CONFERENCE AND
TRAINING SERIES
Investigational Products:
The Clinical Supply Chain –
Transforming for the Future
24 – 25 October 2012
Facilities and Operations Training
22 – 25 October 2012
Mövenpick Hotel Berlin
Berlin, Germany
CONFERENCE OVERVIEW
This conference will address regulatory challenges in the GMP clinical supply chain. It will focus on sharing experiences
and best practices, as well as prepare for future trends. Current hot topics from the industry will be addressed,
including views of regulators in an optimal mix of presentations, case studies and workshops.
For full agenda visit www.ISPE.org/2012ipeuconference
INVESTIGATIONAL PRODUCTS
CONFERENCE PROGRAMME COMMITTEE
Special thanks go to the Conference Programme Committee for their expertise and time in creating this outstanding
professional development opportunity for ISPE.
Co-Chairs
Chedia Abdelkafi, Head of Global CTS Planning, UCB Pharma S.A., Belgium
Christine Milligan, Director Client Services, Fisher Clinical Services, United Kingdom
“The ip european conference
is a unique event because it is
designed by IP professionals
for IP professionals. It embraces
topics that previous delegates
have voted for and offers
unprecedented opportunities for
networking with colleagues and
EU regulators.”
Esther Sadler-Williams,
Senior Director, Strategic
Alliances, Catalent,
United Kingdom
Conference Sessions
Wednesday 24 October
Keynote Session: GMP/GCP Interface at Investigator Sites
Rebecca Stanbrook, Group Manager, Inspections (GCP), MHRA, United Kingdom
What knowledge do you have of investigator sites as a supplies person?
Do you understand the difficulties faced at investigator sites?
This session will present delegates with problems encountered by sites and discovered during inspections, and will
provide an in-depth analysis of the root cause.
Clinical Trial Supplies staff do not see the feasibility to store product at the investigator site and the problems
associated with particular presentations of supplies for patients. This session will provide delegates with
better understanding of what happens to the IMP at investigator sites and will include an overview of issues for
investigators, site staff and patients. It will give delegates concrete examples of how the supplies staff can ensure
the site staff have the information they need. It will explore the different issues associated with investigator sites and
their impact on patients, site and sponsor staffs.
Other sessions will include:
Regulatory Forum
Robert Smith, Director, Smiro Qualitas Ltd, United
Kingdom
Panel Discussion
ISPE Patient Survey
Christine Milligan, Director Client Services, Fisher Clinical
Services, United Kingdom
Clinical Supplies in China
Andrea Zobel, Senior Director, Head of Global Clinical Trial
Distribution, Marken, Germany
Booklet Label Good Practice Guide
Karen Gram, Principal Specialist, Clinical Supplies
Labelling & IT Novo Nordisk, Denmark
This session will present the benefits of creating a
Booklet Label Good Practice Guide and highlight the
recommendations to standardise the design of a
booklet label. It will stress the importance of performing
a gap analysis between the good practice guide and
the company’s current practice, in order to assess the
benefits of changing the current practice.
Workshop A
Introduction to IP COP and Overview of Good
Practice Guide for NonIMPS
Esther Sadler-Williams, Senior Director, Strategic
Alliances, Catalent, United Kingdom
This session aims at raising awareness among delegates
of ISPE IP COP and of the opportunity to participate in
ongoing initiatives within COP.
This presentation will provide delegates with:
• Overview of IP COP and how this works
• Opportunity to learn how they can become a MAL
• Rationale, summary and Status update on the CPG
for NonIMps
Taste and Discover Berlin
Register for the Networking Dinner
Tour Berlin on 24 October!
For more information visit
www.ISPE.org/2012ipeuconference
Conference Sessions
Thursday 25 October
Keynote Session: The Future of the Clinical Supply Chain - How does your Clinical Supply Chain Survive in
these Days of Change and Mergers?
Alexander Debets, Site Head, Merck, Netherlands
The pharmaceutical industry is undergoing a period of unprecedented change resulting from restructuring of many
pharmaceutical companies through mergers and acquisitions. This session will provide delegates with valuable insights
on how to manage a clinical supply chain in times of organisational change.
Other sessions will include:
Technology Now and Future Potential for
Clinical Supplies
Hans Heesakkers, Senior Manager, Accenture,
Netherlands
New technologies like cloud computing, social
networks, JIT Labelling, mPRO, ERP, EBR and 3D
imaging are making their way into the modern world.
This presentation will show how new technologies have
a business case in the future clinical supply chain.
Planning Across the Entire Supply Chain
Paul Skerker, Director, Supply Operations, Millennium
Pharmaceuticals, USA
Case Study: Medication Pooling and IRT
Mike Arnold, Senior Director Strategic Partnerships,
Global Clinical Supply, Pfizer, USA
Panel Discussion
Workshop B
Workshop C
CONFERENCE SCHEDULE-AT-A-GLANCE
Wednesday, 24 October 2012
Thursday, 25 October 2012
09h00 – 10h45
Session Start
08h30 – 10h15
10h45 – 11h15
Networking Break
10h15 – 10h45
11h15 –12h30
Session
10h45 – 12h30
Session
12h30 – 13h30
Lunch
12h30 – 13h30
Lunch
13h30 – 14h45
Session
13h30 – 16h15
Session
14h45 – 15h15
Networking Break
15h15 – 17h15
Session
Monday 22 - Tuesday 23 October 2012
Training Course
Clinical Trial Materials (T13)
Wednesday 24 - Thursday 25 October 2012
Training Course
Oral Solid Dosage Forms (T10)
Training Course
A Risk-Based Approach to GxP Process
Control Systems (T21)
Session Start
Networking Break
For full agenda visit
www.ISPE.org/2012ipeuconference
For full description of the training
courses visit
www.ISPE.org/2012-berlin-octobertraining
ISPE 2012
Investigational Products
Please return to: ISPE Registration Services
Avenue de Tervueren, 300 • B-1150 Brussels, Belgium
Tel: + 32 2 743 44 22 • Fax: + 32 2 743 15 84
E-mail: europeregistrations@ispe.org
Registration form
SAVE TIME – REGISTER ONLINE: www.ISPE.org/2012ipeuconference
I. Delegate Information
Prefix:____________________ First Name:__________________________________ Last Name:_________________________________________________
Job Title:__________________________________________________________ Company:_______________________________________________________
Address:_________________________________________________________________________________________________________________________
City:__________________________________________________ Postal Code:__________________ Country:______________________________________
Telephone:_________________________________________________ Fax:_ ____________________________
Mobile:________________________________________ Email:________________________________________
q I wish to keep my data confidential (only for use by ISPE and its local Affiliates and Chapters)
q I do not wish for my details to be printed in ISPE’s Membership Directory or on Conference Attendance Listings
Company VAT
number (mandatory):
________________________________________
II. Conference Registration
Prices below do not include VAT – 19% German VAT is applicable on registration fees only.
Are you an ISPE Member?
q Yes, membership number: _______________
q No
If you wish to become a Member of ISPE and benefit from lower registration fees, please select New Member registration fees. €210 (VAT exempt)
for your one-year membership is included in the New Member fees indicated below. If you do not wish to become a Member of ISPE, please
select the Nonmember fees.
q Tick here if you are a first time attendee
Registration Fees
(discounts cannot be combined)
Investigational Products
Wednesday 24 October – Thursday 25 October, 2012
ON OR BEFORE
AFTER
30 September 2012
30 September 2012
q ISPE Members
€1.395
€1.595
q ISPE New Members
€1.605
€1.805
q Non ISPE Members
€1.685
€1.895
€700
€700
q ISPE Board & Committees
III. Method of Payment
Conference Fees €
(19% German VAT should be included in the total payment, excluding €210 membership fee on New Member registrations)
19% VAT Total Due: €
€
q Credit Card q Amex
q Visa
q Mastercard­
Cardholder’s Name:_______________________________________________
Credit Card Number: |—|—|—|—| |—|—|—|—| |—|—|—|—| |—|—|—|—|
Expiry Date: |—|—| / |—|—|
Signature:
IV. Special Needs (dietary or other):______________________________________________________________________________________________
V. Dinner Tour Berlin – Wednesday 24 October
Come join your IP colleagues at a ‘Taste and Discover Berlin’ event on Wednesday 24 October.
The Berlin dinner tour is free to all IP Seminar delegates. Will you attend the FREE IP NETWORK DINNER? q Yes
VI. Hotel Information
Mövenpick Hotel Berlin
Schöneberger Strasse 3
D-10963 Berlin, Germany
Tel: +49 30 23 00 60 • Fax: +49 30 23 00 61 99
Room rates:
Single room: €149 (Breakfast included)
Double room: €169 (Breakfast included)
(Rates include 6% VAT, service charge and buffet breakfast
and include city taxes of €6.40/room/night)
VII. Signature
ISPE has secured a number of bedrooms at a fixed group rate for your
convenience. All accommodation bookings must be made directly with the
hotel and are subject to availability.
To benefit from the ISPE group rate, reservations must be received
before 10 October 2012 and the official booking form must be used.
You can make your reservation online through:
https://gc.synxis.com/rez.aspx?Hotel=19862&Chain=7714&Dest=BER&locale=de-DE
&arrive=22.10.2012&depart=24.10.2012&adult=1&child=0&group=MA-MCI-221012
By signing I agree with the ISPE Registration and Cancellation Policies (see www.ISPE.org/2012ipeuconference)
Date:_ ___________________________ Signature:
q No
Facilities and Operations Training
Monday – Tuesday | 22 – 23 October
C
linical Trial Materials (T13)
Extend Your Stay to Attend Professional Development Training
Instructor: Antonia Daniel, Director, Airmid Consulting Limited
CEUs: 1.3
COP: Process / Product Development
Course Level: Intermediate
Do you need solid training in all aspects of CTM Management?
Attend this course to have a thorough understanding of the clinical supply chain from beginning to end,
including translating a clinical study protocol to define CTM supply requirements; knowing how to apply
documentation, cGMPs, and regulatory considerations specifically affecting CTM; preparing a project plan for
all major steps in CTM production – manufacturing, packaging, labelling and distribution; identifying the roles
of the project team; designing appropriate packaging and labelling to match the study design; creating a plan
of action to prepare the CTM and how to implement the plan and troubleshoot. The course will also cover the
logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors
for packaging and labelling and Interactive Response Technology will be covered to ensure familiarity with all
the necessary concepts while applying real-life case studies to your own projects.
Wednesday – Thursday | 24 – 25 October
O ral Solid Dosage Forms (T10)
Instructor: Rob Walker, Director, Rob Walker GMP Consultancy Ltd
Course Level: Fundamental
CEUs: 1.3
COP: OSD
Do you understand the latest issues associated with Oral Solid Dosage Forms?
This course focuses on each discrete processing step (unit operation) required for the manufacture and
packaging of tablets and capsules providing the theory behind basic unit operations; explaining the different
methods for performing a unit operation; describing how product characteristics dictate the unit operations
method; identifying the types of equipment utilised to perform unit operations; how cGMPs influence unit
operations and subsequent equipment design and knowing how to utilise process monitoring techniques
during the scale-up and technology transfer exercise and using the complimentary copy of the ISPE Baseline®
Guide: Oral Solid Dosage Forms (Second Edition).
A Risk-Based Approach to GxP Process Control Systems (T21)
Instructor: : Hilary Mills-Baker, Principal C&I Engineer, Rhombus Engineering LTD and Karen Ashworth, Director, Karen
Ashworth Consulting LTD
Course Level: Intermediate
CEUs: 1.3
COP: GAMP®
Are your process control systems fit for use?
This highly interactive course recommends good practices based on lifecycle approaches for the development
and management of process control systems and shows how the principles and concepts of GAMP®5 may
be practically applied to process control systems. The course covers both regulated company and supplier
quality management systems and the full system lifecycle from concept to retirement. You will learn how
appropriate QRM and specification and verification activities should be an integral part of the normal system
lifecycle. Many suppliers of systems now have mature quality management systems and system development,
test and support documentation. The course promotes the leveraging of supplier documentation and activities
to avoid unnecessary duplication, cost and waste and leverages the complimentary copy of the GAMP® Good
Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition).
Visit www.ISPE.org/2012-berlin-october-training to view the full course descriptions.
Berlin TRAINING
ISPE 2012
Mövenpick Hotel Berlin
22 October – 25 October 2012
TRAINING SERIES
REGISTRATION FORM
Please return to: ISPE Registration Services
Avenue de Tervueren, 300 • B-1150 Brussels, Belgium
Tel: + 32 2 743 44 22 • Fax: + 32 2 743 15 84
E-mail: europeregistrations@ispe.org
SAVE TIME – REGISTER ONLINE: www.ISPE.org/2012-berlin-october-training
I. Delegate Information
Prefix:__________________ First Name:___________________________________________ Last Name:_ ___________________________________________
Job Title:______________________________________________________________ Company:____________________________________________________
Address:___________________________________________________________________________________________________________________________
City:____________________________________________ Postal Code:________________ Country:________________________________________________
Telephone:_ _______________________________________ Fax:_ _____________________________________
Company VAT number (mandatory):
Mobile:___________________________________________ Email:_____________________________________
__________________________________________
q I wish to keep my data confidential (only for use by ISPE and its local Affiliates and Chapters)
q I do not wish for my details to be printed in ISPE’s Membership Directory or on Conference Attendance Listings
II. Conference Registration
Prices below do not include VAT – 19% German VAT is applicable on registration fees only.
Are you an ISPE Member? q Yes, membership number: __________________ q No
If you wish to become a Member of ISPE and benefit from lower registration fees, please select New Member registration fees.
€210 (VAT exempt) for your one-year membership is included in the New Member fees indicated below. If you do not wish to become a
Member of ISPE, please select the Nonmember fees.
q Tick here if you are a first time attendee
EARLY BIRD ON OR BEFORE
30 September 2012
BERLIN TRAINING 2012
FACILITIES AND OPERATIONS
REGULAR / ONSITE
30 september 2012
Member
New
Member
Nonmember
Member
New
Member
Nonmember
q Clinical
Trial Materials (T13)
Two Day Course: Monday 22 October – Tuesday 23 October
€1.510
€1.720
€1.805
€1.710
€1.920
€2.015
qO
ral Solid Dosage Forms (T10)
Two Day Course: Wednesday 24 October – Thursday 25 October
€1.610
€1.820
€1.910
€1.810
€2.020
€2.120
q A Risk-Based Approach to GxP Process Control Systems (T21)
Two Day Course: Wednesday 24 October – Thursday 25 October
€1.610
€1.820
€1.910
€1.810
€2.020
€2.120
MONDAY 22 OCTOBER – THURSDAY 25 OCTOBER, 2012
III. Method of Payment
(19% German VAT should be included in the total payment, excluding €210 membership fee on New Member registrations)
Seminar Fees €______________________________________
19% VAT €__________________________________________
Total Due: €________________________________________
q Credit Card q Amex
q Visa
q Mastercard­
Credit Card Number: |—|—|—|—| |—|—|—|—| |—|—|—|—| |—|—|—|—|
Expiry Date: |—|—| / |—|—|
Cardholder’s Name:_______________________________________________________________________________ Signature:
IV. Special Needs (dietary or other):_________________________________________________________________________________________________
V. Hotel Information
Mövenpick Hotel Berlin
Schöneberger Strasse 3
D-10963 Berlin, Germany
Tel: +49 30 23 00 60
Fax: +49 30 23 00 61 99
Room rates:
Single room: €149 (Breakfast included)
Double room: €169 (Breakfast included)
(Rates include 6% VAT, service charge and buffet
breakfast and include city taxes of €6.40/room/night)
ISPE has secured a number of bedrooms at a fixed group rate for
your convenience. All accommodation bookings must be made directly
with the hotel and are subject to availability.
To benefit from the ISPE group rate, reservations must be received before
10 October 2012 and the official booking form must be used.
You can make your reservation online through:
https://gc.synxis.com/rez.aspx?Hotel=19862&Chain=7714&Dest=BER&locale=de-DE&
arrive=22.10.2012&depart=24.10.2012&adult=1&child=0&group=MA-MCI-221012
VI. Signature
By signing I agree with the ISPE Registration and Cancellation Policies (see www.ISPE.org/2012-berlin-october-training)
Date:_______________________________ Signature:
SPONSORSHIP AND EXHIBITION
Event Sponsorships Provide Valuable Exposure
ISPE hosts several high-profile events each calendar
year, providing you with multiple opportunities to gain
excellent exposure for your company. Choose from a
variety of sponsorship packages to enjoy value-added
benefits that will give you an edge on your competition.
Build brand awareness and engage with decisionmakers and buyers of production-related equipment
and services as an ISPE Event Sponsor or Exhibitor.
Introduce your products and services to an
audience actively seeking solutions to GMP challenges.
ISPE Conferences attendees include senior level
executives and management from top pharmaceutical
companies around the world in search of solutions that
will help them lower production costs, improve process
efficiencies, increase production quality and meet
regulatory compliance.
Two Days Table Top Package - €1.550 (+ VAT)
15% discount for Table Top Personnel to attend a Seminar session
One banquet table (180cm x 80cm) to display your literature, products and
services
Access to all Coffee/Lunch Breaks and to the Networking reception
Your company description (Logo plus 15-word description) in the Exhibitor roster
included in the Delegate Welcome Package
Two-day Exhibition Guest Pass
Onsite, personnel assistance from ISPE exhibition staff
Premium Table Top - €1.780 (+VAT)
This includes:
All items listed for Table Top Package
Priority choice of Table Top allocation (subject to availability)
Prominent listing in Exhibitor Directory featuring:
Company logo
30-word company description
Two Days Table Top Package plus Technology Session - €3.050 (+VAT)
This includes:
All items listed for Table Top Package
Take your brand centre stage with a 20’ commercial
Presentation during a Coffee Break of your choice
Technology Session advertised in all event marketing communication
Invitation in the Delegates’ Welcome Pack
Sponsorship Opportunities Available
Platinum Sponsor
Sponsoring an ISPE event is a cost-effective way to gain competitive advantage,
increase name recognition, and create top-of-mind awareness in today’s pharmaceutical
science and biotechnology manufacturing industry. Sponsorships include pre-event
exposure on the ISPE website as well as the delegate mailing list, onsite exposure
with exhibit opportunities, company logo on signage, and mentions in print and
electronic communication. For more information about our Host, Platinum, or Gold
Sponsorship, please contact:
Murat Dogru
European Sales Manager
murat.dogru@associationhq.com
+32 2 743 44 27
Tanguy Roelens
European Sales Associate
tanguy.roelens@associationhq.com
+32 2 740 22 54
Upcoming ISPE Events in 2012
ISPE October Conferences
ISPE November Training
“Process Validation”
17 – 18 October 2012
Silver Spring, Maryland, USA
“Quality Risk Management,
GAMP® 5 and Turning QbD into
a Practical Reality”
ISPE Annual Meeting
11 - 14 November 2012
San Francisco, California, USA
“Global GMP Solutions Through Innovation
and Transformation”
11 - 14 November 2012
San Francisco, California, USA
ISPE December Training
“Water, Project Management, Sterile,
GAMP® 5, Science and Risk-Based C&Q,
Auditing and Cleaning Validation”
3 - 6 December 2012
Tampa, Florida, USA
We shaped the pathways – both virtual and actual – that get your
investigational product exactly where it needs to be. That means
more than moving something from one place to another quickly.
Our clinical supply chain specialists safely orchestrate the appropriate
packaging, labeling, storage, and delivery of your medical therapy to
the patients who need it within the specific time and temperature
parameters required. We understand what you want, we know what
to do and we designed our systems and facilities to help keep your
product safe and have it arrive in exactly the condition you require.
What counts is
not only where
it needs to be,
but where it is.
Right now.
• Largest global footprint
• 18 fully owned, strategically
located facilities
• Over 25 years of expertise
in managing investigational
materials
• Expert navigators of
international regulations
and requirements
• More than 2 million clinical
supply shipments globally
• Continuously monitered
cold chain support
• 24/7 real time program
management
• Globally integrated project
teams
• Dedicated to ensuring the
viability of your critical
investigational materials
Fisher Clinical Services … always where you need us, with what
you need, exactly when you need it
For more information please visit
us at fisherclinicalservices.com.
+44 1403 212700
fscinfo@thermofisher.com