ISPE 2012
CONFERENCE AND
TRAINING SERIES
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 decision-makers 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.
Upcoming ISPE Events in 2012
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
ISPE September Conferences
ISPE October Training
“Contemporary Trends in Facilities and
Compliance”
“Facilities and Operations”
17 - 18 September 2012
Brussels, Belgium
GAMP® European Conference:
“Understanding the Business Benefits
and Compliance Risks from Evolving
Computerised Solutions and IT
Services”
19 - 20 September 2012
Brussels, Belgium
“Global GMP Solutions Through
Innovation and Transformation”
11 - 14 November 2012
San Francisco, California, USA
ISPE November Training
“Facilities and Operations”
17 - 20 September 2012
Brussels, Belgium
11 - 14 November 2012
San Francisco, California, USA
“Clinical Trials, GAMP® 5, HVAC,
Sterile, Project Management and
Water”
ISPE December Training
24 - 27 September 2012
Chicago, Illinois, USA
ISPE October Conferences
“Process Validation”
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:
17 – 18 October 2012
Tanguy Roelens
European Sales Associate
troelens@ispe.org
+32 2 740 22 54
ISPE Annual Meeting
“Quality Risk Management,
GAMP® 5 and Turning QbD into
a Practical Reality”
ISPE September Training
Sponsorship Opportunities Available
Murat Dogru
European Sales Manager
murat.dogru@associationhq.com
+32 2 743 44 27
22 - 25 October 2012
Berlin, Germany
Silver Spring, Maryland, USA
“Water, Project Management, Sterile,
GAMP® 5, Science and Risk-Based
C&Q, Auditing and Cleaning Validation”
3 - 6 December 2012
Tampa, Florida, USA
Back to Basics:
Transforming the
Pharmaceutical Supply Chain
22 – 23 October 2012
Facilities and Operations Training
22 – 25 October 2012
“Investigational Products”
24 - 25 October 2012
Berlin, Germany
Mövenpick Hotel Berlin
Berlin, Germany
Berlin TRAINING
ISPE 2012
Facilities and Operations Training
CONFERENCE OVERVIEW
SAVE TIME – REGISTER ONLINE: www.ISPE.org/2012-berlin-october-training
Monday – Tuesday | 22 – 23 October
This conference will provide insight into the critical-to-success factors in pharmaceutical supply chains.
It will focus on how the industry can achieve world-class performance levels and transparency in the
end-to-end networks with a better understanding of how to deliver value to all stakeholders to which
the pharmaceutical supply chain industry relates.
Special thanks go to the Conference Programme Committee for their expertise and time in creating
this outstanding professional development opportunity for ISPE.
Programme Chair
Jim McKiernan, CEO, McKiernan Associates, Switzerland
Programme Members
Ali Afnan, President, Step Change Pharma, USA
Roddy Martin, Senior Vice President Global Supply Chain, Competitive Capabilities International, Inc., USA
Bryan Wright, ISPE Regulatory Advisor, United Kingdom
C linical Trial Materials (T13)
Extend Your Stay to Attend Professional Development Training
PHARMACEUTICAL SUPPLY CHAIN
CONFERENCE PROGRAMME COMMITTEE
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
The pharmaceutical industry is committed to the development and manufacturing of safe and quality
medicines. Therefore, implementing a reliable supply chain which is responsive to true demand and
understands the voice of the customer is a key requirement.
The programme will include keynote speeches delivered by senior level industry experts and eminent
professionals from regulatory authorities.
Mövenpick Hotel Berlin
22 October – 25 October 2012
TRAINING SERIES
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.
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
16 SEPTEMBER 2012
BERLIN TRAINING 2012
FACILITIES AND OPERATIONS
MONDAY 22 OCTOBER – THURSDAY 25 OCTOBER, 2012
REGULAR / ONSITE
16 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 Days Course: Wednesday 24 October – Thursday 25 October
€1.610
€1.820
€1.910
€1.810
€2.020
€2.120
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
ISPE has secured a number of bedrooms at a fixed group rate for
your convenience. All accommodation bookings must be made
Mövenpick Hotel Berlin
Schöneberger Strasse 3
D-10963 Berlin, Germany
Tel: +49 30 23 00 60
Fax: +49 30 23 00 61 99
directly with the hotel and are subject to availability.
To benefit from the ISPE group rate, reservations must be received before
10 September 2012 and the official booking form must be used.
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)
You can make your reservation online through:
https://gc.synxis.com/rez.aspx?Hotel=19862&Chain=7714&Dest=BER&lo
cale=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:
PLENARY SESSION
Join us for a dynamic Plenary Session designed to address significant challenges in the global supply chain.
• The pharmaceutical sector is still lagging behind world-class practices in manufacturing and supply
chain. What are the causes of this and how can the industry realise a break with past practices and
assumptions?
• How can we achieve robust and secure supply chains to minimise the risk of counterfeiting and
product diversion?
• What are the real causes of drug shortages and how can they be resolved?
“Effective Supply Chain Integrity through Process Improvement” – Dr. Heike Falkenhagen, Head of Global
Quality Services, will present the approach taken by Boehringer-Ingelheim and key lessons learned.
“What Does GMP Really Mean? How the Blind Pursuit of Meeting Regulatory Compliance Standards Is Really
Not Enough” – Dr. Ali Afnan, President, Step Change Pharma, will address why Pharma needs to look beyond
this narrow perspective and learn from other industries on how to achieve consistent, controlled quality
through a thorough understanding of the science.
“The Implications of the New Falsified Medicines Directive on Supply Chain” – Dr. Richard Andrews,
GDP Operations Manager, MHRA, will address key components of the Directive designed to control the
occurrence of sub-standard or falsified ingredients and finished products reaching patients via the legal
supply chain, limit the number of expensive medicinal product recalls, and prevent the possibility of serious
damage to public health.
SESSION 1:
ENTERING A NEW ERA OF SUPPLY CHAIN
Creating and maintaining a supply chain that is responsive to true demand and understands the voice of
the customer will be critical to the industry’s success in the coming decades. Understand the changing
drivers in supply chain and ensure the achievement of such goals through relevant case studies and open
discussion.
Setting the Scene
Roddy Martin, Senior Vice President Global Supply Chain, Competitive Capabilities International, Inc.
Learning from Other Industries – A Case Study on Capacity Sharing in Pharma
Aeneas Marxen, PhD, Consultant, PharmaCentaur
How Well Connected Is the Pharmaceutical Supply Network?
Nick Davies, CEO & Principal Consultant, NDA Consultants
“EU Competent Authorities are required to transpose many of the changes introduced by the Falsified
Medicines Directive into national law by 2 January 2013. From this date Inspectors will expect
companies to be in compliance with the regulations. Manufactures, Wholesale Distributors and
Brokers of medicinal products therefore need to be aware of and understand the new requirements
as do manufacturers, importers and distributors of active substances.”
Dr. Richard Andrews, GDP Operations Manager, MHRA
SESSION 2:
LESSONS FROM NON-PHARMA INDUSTRIES
Analyse and discuss examples of best practices both within the industry as well as from leading players
in other sectors. Learn from regulatory authorities the keys to ensuring the uninterrupted supply of quality
medicines.
The Role of Standards in Enforcing Process Validation
Alex Viehmann, Operations Research Analyst at FDA, CDER, Office of Pharmaceutical Science
Why can’t Pharma Supply be Managed like other Successful Sectors?
Joseph Paris, Chairman, XONITEK Group Of Companies
How Well Connected is the Pharmaceutical Supply Network?
Nick Davies, CEO & Principal Consultant, NDA Consultants
Join us for the Pharma Café!
This unique learning opportunity will offer delegates an informal opportunity to engage with subject
matter experts in discussing topics such as:
• New Directions in Supply Chain Strategy
• Impact of Supply Chain Pedigree
• Falsified Medicines Directives
Share your experiences, challenges, and questions with fellow delegates and the experts.
Topic groups will be fluid, offering the opportunity to listen in and contribute to more than one
discussion group. Group facilitators will share the results of topic discussions with all conference
attendees at the conclusion of this dynamic session.
SESSION 3:
ANTICOUNTERFEITING AND SUPPLY CHAIN INTEGRITY
Supply chain integrity throughout the product lifecycle presents one of the most significant industry
challenges facing manufacturers and regulatory agencies today. Be a part of this provocative dialogue
as industry and regulatory leaders grapple with issues related to anti-counterfeiting, safety, and reliability.
Industry & Regulatory Panel
Moderated by Bryan Wright, ISPE Regulatory Advisor
Dr. Richard Andrews, GDP Operations Manager, MHRA
Alex Viehmann, Operations Research Analyst at FDA, CDER, Office of Pharmaceutical Science
Dr. Ali Afnan, President, Step Change Pharma
Dr. Heike Falkenhagen, Head of Global Quality Services, Boehringer-Ingelheim
CONFERENCE SCHEDULE-AT-A-GLANCE
Monday, 22 October 2012
07h30 – 08h30
Exhibit Hall Opens
09h00 – 12h00
Plenary Session
12h00 – 13h30
Lunch
13h30 – 17h00
Session 1: Entering a New Era of Supply Chain
17h00 – 18h30
Exhibition Networking Reception
09h00 – 12h30
Session 2: Lessons from Non-Pharma Industries
12h30 – 14h00
Lunch
14h00 – 17h00
Session 3: Anticounterfeiting and Supply Chain Integrity
Training Course
Clinical Trial Materials (T13)
Training Course
Oral Solid Dosage Forms (T10)
Training Course
A Risk-Based Approach to GxP Process Control Systems (T21)
Tuesday, 23 October 2012
Monday 22 - Tuesday 23 October 2012
Wednesday 24 - Thursday 25 October 2012
For full agenda visit www.ISPE.org/2012-pharmaceutical-supply-chain-eu-conference
For full description of the training courses visit www.ISPE.org/2012-berlin-october-training
ISPE 2012
Pharmaceutical Supply Chain
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
Registration form
E-mail: europeregistrations@ispe.org
SAVE TIME – REGISTER ONLINE: www.ISPE.org/2012-pharmaceutical-supply-chain-eu-conference
I. Delegate Information
Prefix:___________ First Name:_____________________________ Last Name:__________________________________________
Job Title:________________________________________________ Company:____________________________________________
Address:____________________________________________________________________________________________________
City:_________________________________________ Postal Code:_____________ Country:_ ______________________________
Telephone:___________________________________ Fax:_ _____________________________
Mobile:______________________________________ Email:_____________________________
Company VAT number (mandatory):
__________________________
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
Registration Fees (discounts cannot be combined)
Back to Basics: Transforming the Pharmaceutical
ON OR BEFORE
16 September 2012
Supply Chain
Monday 22 October – Tuesday 23 October, 2012
AFTER
16 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
(19% German VAT should be included in the total payment, excluding €210 membership fee on New Member registrations)
Conference 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 September 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&loc
ale=de-DE&arrive=22.10.2012&depart=24.10.2012&adult=1&child=0&gro
up=MA-MCI-221012
VI. Signature
By signing I agree with the ISPE Registration and Cancellation Policies
(see www.ISPE.org/2012-pharmaceutical-supply-chain-eu-conference)
Date:____________________________________ Signature: