More at: http://www.authentication-pharma.com/web Learn about Legislative & Regulatory Infrastructure and how to successfully use Anti-Counterfeiting technologies to reduce costs and increase your business value The production and trade of falsified medicines has become a growing worldwide illegal business. Für Pharmaunternehmen sind gefälschte Arzneimittel der Einnahmeverlust ein finanzielles Desaster. Unser vornehmlich englisch-sprachiger Kongress schafft eine Plattform für alle Beteiligten: von Aufsichtsbehörden, Europol bis zu Industrieexperten. More at: http://www.authentication-pharma.com/web

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2nd Congress
Global Pharma
AuthenticAtion 2011
Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies –
Business value and cutting cost
4 – 6 July 2011 | Steigenberger Hotel, Berlin
Visit our download center for free white papers, articles and much more! www.authentication-pharma.com/MM
Hear international top-level speakers • Hear first hand updates on EU Falsified Medicines Directive and its impact on the fight against
from:
counterfeiting
• European Commission
• Gain practical insights into the methods applied by national and international investigative
• Roche Pharma GmbH
authorities in the fight against counterfeits
• Novartis Pharma
• Pfizer GmbH • Understand the methods and procedures of counterfeiting and how to apply counter-actions
• MEDA Pharma GmbH & Co. KG • Learn about combining secure identification systems such as RFID and 2D Data Matrix to
• PAREXEL International GmbH improve packaging security
• German Pharmaceutical Industry • Improve the supply chain on several levels to ensure a secure and compliant product supply
Association BPI e.V. chain
• University of Hamburg
• GS1 Germany
Benefit from the following experts including:
• TFH Wildau – University of Applied
Science Menno Vlietstra, Michael Ritter,
• Quality Association for Head Supply Chain IT, Project Manager Serialization
Pharmaceutical Packaging QAPP Roche Pharma GmbH & Product Tracking,
Novartis Pharma
• National Agency for Food and Kerstin Schrade-Butscher,
Drug Administration and Control Intelligence Analyst, Bérengère Dreno,
NAFDAC, Nigeria Pfizer GmbH/Global Security Junior specialist,
• European Association of Operational department,
Dr. Paul B. Orhii, Europol
Pharmaceutical Full-line Director General,
Wholesalers GIRP NAFDAC
• Europol
• Eurojust
Sponsors Interactive Workshop Day | Monday, 4 July 2011
A: EU Falsified Medicines Directive – How much security/safety will be achieved?
B: Contractual relationships with suppliers regarding the subject of counterfeiting
Researched and
developed by C: Implementation of serialization and product tracking
D: Corporate Security Anti-Counterfeiting Strategies
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.authentication-pharma.com/MM

2. 2nd Congress
Global Pharma AuthenticAtion 2011
Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies – Business value and cutting cost
4 – 7 July 2011 | Steigenberger Hotel, Berlin
Dear Colleagues, Who will you meet?
The production and trade of forged medicines is a growing illegal business worldwide. Counterfeit medicine
Global heads, directors and project
poses a public health risk because their content can be dangerous, often lacking active ingredients. Their use
managers of the following departments
can result in treatment failure or even worse death. Counterfeit medicines find their way into the supply
chain via internet pharmacies and increasingly other legal distribution and sales outlets. For pharmaceutical • Supply chain
• Anti-counterfeit strategies
companies the loss of income and loss of branding reliability can be financially devastating. Additionally anti-
• Packaging & Labelling
counterfeiting measure and strategies can be cost-intensive – however, way are becoming more and more
• egulatory Affairs/Corporate Security/
R
important.. Brand Protection
In February the European Parliament has adopted a new EU law on falsified medicines in an attempt to ensure
that only high-quality medicines reaches the legal supply chain. The new EU Directive introduces harmonized,
pan-European safety measures and will touch all stakeholders concerned in the daily delivery of medicines.
However, many countries are adopting their own regulations for the implementation of authentication systems.
As a result it is getting increasingly difficult for pharmaceutical companies to meet all requirements and keep
their products secure. Sponsorship
Join our international We have a variety of packages
available to suit your requirements.
2nd Congress For all Sponsorship and Exhibition
opportunities call Catharina Piehler:
Global Pharma Authentication 2011 +49 (0)30 20 91 32 75 or
email catharina.piehler@iqpc.de
Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies –
Business value and cutting cost
Congress days 5 – 6 July 2011 Our Sponsor
Workshops 4 July 2011
Steigenberger Hotel Berlin, Germany
Bluhm Systeme GmbH
Benefit from expert opinions and Maarweg 33
59619 Rheinbrettbach
• Ensure industry collaboration in the fight against ‘online pharmacies’ and use of internet to
Germany
purchase illegal medicines
+49 (0)2224 7708 7100
• Implement Serialisation and Product Tracking successfully to protect patient safety +49 (0)2224 7708 20
• Discuss new technology developments and the impact on pharmaceutical anti-counterfeiting info@bluhmsysteme.com
• Discover Nigeria‘s multi-layered approach to fight against counterfeit drugs www.bluhmsysteme.com
Save your place and book now! We look forward to meeting you in Berlin!
Kind regards,
Team Discounts
We are offering attractive Team For further information
Monica Wick
Discounts, please contact us!
Project Manager Please visit our website
www.authentication-pharma.com/MM
or contact Kai Dodschat on
+49 (0)30 20 91 32 74 or
email eq@iqpc.de
What’s in your download center?
The purpose of the download center is to provide you with relevant content to enhance your knowledge of cur-
rent trends and industry news. All content is 100% complimentary, easy to download, and current.
Featuring live podcast interviews which you can stream on your computer or portable device, up-to-date news
from local and international sources, industry whitepapers, and other relevant content – the download center is
Register for our email
your online portal to expand your knowledge and add value to your business.
updates!
We encourage your feedback and participation, for all comments or enquiries please contact Kai Dodschat on
+49 (0)30 20 91 32 74 or email eq@iqpc.de! Get the latest news on our events,
additional download possibilities,
early bird deadlines and much more!
Get free white papers, articles and much more! Register now at
www.authentication-pharma.com/MM www.authentication-pharma.com/MM
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.authentication-pharma.com/MM

3. 2nd Congress
Global Pharma AuthenticAtion 2011
Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies – Business value and cutting cost
INTERACTIVE WORKSHOP DAy | Monday, 4 July 2011
A: 09:30 – 13:00 | EU Falsified Medicines Directive – How much security/safety will be achieved?
Resolution of 16 February 2011 on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as
regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
(COM(2008)0668 – C6-0513/2008 – 2008/0261(COD)). The resolution for the new EU-legislation represents a milestone for achieving safety and
security in the legal supply chain for patients. How much security/safety will be achieved or could we identify gaps and holes in the new legislation?
The following subjects related to the new legislation will be discussed:
• Will there be problems in implementation?
• What is perfect – what could or should be improved?
• Do we face a crime with multiple causes – Will there ever be a single technical measure to cover all aspects for all times?
• Are we facing a steady process?
Dr. Irene Schwier, Institut für Organische Chemie, Universität Hamburg
B: 09:30 – 13:00 | Contractual relationships with suppliers regarding the subject of counterfeiting
Manufacturing authorization holders are responsible for the supplies. Supplier qualification is legally regulated. Omissions may have major effects
(see Heparin-cases). Thus supplier-management is part of the Good Manufacturing Practice (GMP). On the other hand “suppliers-GMP” reduces the
need for controlling incoming goods. Details of the contractual relationship with the supplier have to be set forth in a written contract. Contents,
scope of such contracts and keeping them updated will be discussed in the workshop.
• Liability Systems
• Transfer of obligations
• Contents of Quality Assurance Agreements
• Technical Agreements
• International Contracts
Dr. Martin Wesch, Executive Secretary, Quality Association for Pharmaceutical Packaging (QAPP)
C: 14:00 – 17:30 | Corporate Security Anti-Counterfeiting Strategies
Serialization and track & trace are just one side of effective product security. to fight counterfeits thoroughly pharmaceutical companies need to make
it a corporate security priority and investigate themselves. The workshop gives the participants insider information on corporate anti-counterfeiting
strategies and supports them in implementing their own anti-counterfeiting methods. Especially cooperating with the authorities on a national and
international level is highly important for a successful fight against counterfeits. The workshop will provide you with information on corporate
security in Europe and other world regions. The following topics will be covered:
• Current trends in the counterfeiting of pharmaceuticals
• International experience
• Fighting illegal imports via the internet
• Cooperating with authorities
• Recent case reviews
For further information, please visit our website on: www.authentication-pharma.com/MM
D: 14:00 – 17:30 | Implementation of serialization and product tracking
Serialization in combination with track and trace systems is the most effective solution to take measures against counterfeit medicines. Currently the
2 D Data Matrix seems to be the best system at hand considering costs and usability. Several countries have already started using mass
serialisation systems, others are planning to implement their own system in the near future. The EU and the US are working on individual harmonized
authentication systems. Which effects do these developments have on pharmaceutical companies? The workshop will give an overview which
steps have to be taken on the way to implementing mass seriali ation and track & trace successfully.
s
• mass Serialisation & Data matrix Code
• evelopment in europe and north America
D
• Requirements to implement mass serialisation in pharmaceutical companies
Dipl. Ing. Götz Frhr. von Arnim, COIDA Competence Center for Object-ID and -Authentication, TFH Wildau – University of Applied Science
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.authentication-pharma.com/MM

4. 2nd Congress
Global Pharma AuthenticAtion 2011
Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies – Business value and cutting cost
CONGRESS DAy ONE | Tuesday, 5 July 2011
09:30 Registration with coffee and tea 13:30 networking Luncheon
09:55 Chairman’s welcome & opening address 15:00 Fake medicine crime – role of EUROJUST in combating
Thomas Brückner, Head of Pharmaceutical Affairs/CAM/ Insight serious crime
Medical Devices, Eurojust • Fake medicine crime (case example)
German Pharmaceutical Industry Association (BPI e.V) • Cross border investigation
• Problems on the judicial level
• Added value of using EUROJUST
• Conclusions
Global legislative and regulatory infrastructure Benedikt Welfens, Deputy to the National Member
for Germany,
Eurojust
10:00 EU anti-counterfeit legislation and the German
EU Pilot project 15:45 Falsified Medicines – liability and legal measures in
Directive • Current European legislation (Dir. 2001/83/EC) Europe
EU Legal
• implementation into german Law Measures • Criminal, strict and tort liability for falsified medicinal
• Coding – Technical Details products
• German Pilot Projekt • EU Proposal on legal improvements
• Outlook – Safety features
Thomas Brückner, Head of Pharmaceutical Affairs/CAM/ – Strengthened requirements as to control and
Medical Devices, inspection of APIs
German Pharmaceutical Industry Association (BPI e.V) – Reporting duties
– Trust mark for the internet selling
• Quality risk management as to packaging, design and
labelling
H
ig
10:45 Nigeria‘s multi-layered approach to fight against
hl
Dr. Martin Wesch, Executive Secretary,
ig
Case counterfeit drugs
ht
Quality Association for Pharmaceutical Packaging
Study • Safeguarding Public Health
Regulatory
(QAPP)
• Cutting Edge Technologies
Authority
• Advancement of regulatory oversight
• idespread and cost effective method of nAfDAC
w 16:30 Refreshment break & networking
control
• Cooperation and partnerships with technology providers,
private sector companies, law enforcement, customs 17:00 The Distributor’s responsibilities
and the media Distributor’s • Distribution and wholesale are critical elements of supply
Dr. Paul B. Orhii, Director General, National Agency for Point • EU Directive will place significant responsibilities on
Food and Drug Administration and Control of View these activities in order to preserve the integrity of the
NAFDAC supply chain
• What will be required and how can these supply chain
actors ensure that Europe moves seamlessly towards
the new legislative framework?
11:30 Refreshment break & networking Martin Fitzgerald, Legal Director,
European Association of Pharmaceutical Full-line
Wholesalers (GIRP)
12:00 Fake medicines and serious & organised crime
European • The opinion of an expert
Commission • Scope of fake medicines (counterfeiting and falsified) 17: 45 Closing remarks of the chairman and end of day one
• Transborder crime, serious and organised crime
• Domestic and European framework
• Law enforcement cooperation
Christian Tournie, Seconded National Expert (counter-
feiting, fake medicines, financial investigation), (TBC), Promote your Business!
European Commission – DG Home Affairs – Unit Fight
We have a wide range of proven sponsoring, branding and
Against Organised Crime
marketing opportunities available.
Contact Catharina Piehler for more information:
H
+49 (0)30 20 91 32 75 or email catharina.piehler@iqpc.de
ig
12:45 Europol and the fight against fake pharmaceuticals
hl
ig
• General overview of Europol
ht
Case
Study • Scope of the phenomenon of fake medicines
• The fight against fake medicines on a multi-agencies
level Register for our email updates!
• Cooperation between Europol and private sector
• Case studies Get the latest news on our events, additional download
Bérengère Dreno, Junior specialist – Criminal finances possibilities, early bird deadlines and much more!
and technology unit – Operational department, Register now at www.authentication-pharma.com/MM.
Europol
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.authentication-pharma.com/MM

5. 2nd Congress
Global Pharma AuthenticAtion 2011
Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies – Business value and cutting cost
CONGRESS DAy TWO | Wednesday, 6 July 2011
8:30 Registration with coffee and tea 14:00 Counterfeit medication in clinical trials
Case • Why is there a risk?
8:55 Chairman’s welcome & opening address Study • How to reduce the risk?
• erialization/track & trace in Clinical trials?
S
Heidemarie Thorwartl, Sr. Manager OpsqM,
PAREXEL International GmbH
Best Practices Serialization, Product Tracking & Anti-Counterfeiting
14:45 Encreasing Supply Chain Quality with Track & Trace
• Overview of GS1 standards for optimizing supply chain
H
Case
9:00 Counterfeit pharmaceuticals – a threat to patients
ig
processes
hl
Study
ig
Case health and safety
ht
• rack & trace vs. Serialization
t
Study • Scope of the problem
• Benefits of Traceability solutions
• oLPs and b2b
• How does Traceability work?
• Pfizer security features
• Concepts of Information sharing
• Pfizer/Le investigations
Michaela Hähn, Senior-Projektmanager,
Kerstin Schrade-Butscher, Intelligence Analyst,
GS1 Germany
Pfizer GmbH/Global Security
15:30 Refreshment break & networking
09:45 Cost effective Anti-Counterfeiting enforcement program
Case • Control of suppliers to prevent distribution of material
16:00 Panel Discussion:
Study produced for the originator into illegal traffic
Harmonized product tracking for the EU & North
• Measures to prevent the infiltration of falsified raw
America – How realistic is a consistent approach and
materials into the supply chain
how successful would it be?
• Identifiers allowing to distinguish between original and
• The European and the American approach – Differences
falsified products
and similarities
• Tamper evident product design to allow easy identifica-
• Steps to be taken to a harmonized system – Is it worth
tion of manipulations
the effort?
• abelling/markers to allow product tracking in the
L
• Comparing the status quo of implementation – Who
distribution chain
ever goes first gets to decide?
• Implementation of IT infrastructure to support the
Speakers of the day
product tracking
• Information exchange with customs, police, public
prosecutors offices 16:45 Product security in parallel distribution – A pilot project
• Modification of the processes to check compliance of of the reimport industry to connect to European
Parallel
re-packaging/re-labelling by parallel importers Distributor’s verification systems
Horst Kastrup, Senior Regulatory Advisor, Pilot Project • Regulatory framework and practice ensuring product
MEDA Pharma GmbH & Co. KG safety in parallel distribution
• EAEPC initiatives to supply chain safety
10:30 Refreshment break & networking • First learnings from a pilot project connecting re-import
to the Aegate system of authentication/verification
Dr. Heinz Kobelt, Secretary General,
H
ig
11:00 The Roche Global Supply Chain Strategy to EAEPC
hl
ig
reduce risk
ht
Case
Study • Strategic context and program set up
17:30 Closing remarks of the chairman and end of congress
• Deliverables so far
day two
• First pilots
• Potential other business benefits
Menno Vlietstra, Head Supply Chain IT,
Roche Pharma GmbH
H
11:45
ig
Implementation of Serialisation and Product
hl
ig
Case Tracking project at Novartis Pharma Beijing
ht
Study • Project scope IQPC provides business executives around the world with tailored
• Challenges practical congresses, large scale events, topical seminars and
• Lessons learnt in-house training programs, keeping them up-to-date with industry
• Outlook trends, technological developments and the regulatory landscape.
Michael Ritter, Project Manager Serialization & IQPC’s large scale congresses are market leading “must attend”
Product Tracking, events for their respective industries. IQPC produces more than
Novartis Pharma 1,500 events annually around the world, and continues to grow.
Founded in 1973, IQPC now has offices in major cities across 5
continents including: berlin, Dubai, London, new york, São Paulo,
12:30 networking Luncheon Singapore, Stockholm, Sydney and Toronto. IQPC leverages a global
research base of best practices to produce an unrivalled portfolio of
congresses. www.iqpc.de
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.authentication-pharma.com/MM

6. 2nd Congress 4 Ways to Register
Global Pharma Fax: +49 (0)30 20 91 33 12
AuthenticAtion 2011 Post: IQPC Gesellschaft für
Management Konferenzen mbH
Friedrichstraße 94
4 – 6 July 2011 I Steigenberger Hotel Berlin
10117 Berlin, Germany
Online: www.authentication-pharma.com/MM
If undeliverable, please return to: Email: info@iqpc.de
IQPC GmbH | Friedrichstraße 94 | D-10117 Berlin, Germany
For further information
Phone: +49 (0)30 20 91 33 30
booKingCoDe
Kai Dodschat #GTS/KDO
Venue and Accommodation
Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin, Germany
Tel.: +49 (0)30 2127 0
Fax: +49 (0)30 2127 117
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yOUR DETAILS: PLeASe ContACt ouR DAtAbASe mAnAgeR (veRteiLeR@iQPC.De) AnD infoRm them of Any inCoRReCt www.berlin.steigenberger.de
DetAiLS whiCh wiLL be AmenDeD ACCoRDingLy
Congress Packages Early Bird
Standard Price Accommodation: A limited number of reduced rate rooms
(Book and pay by the 29 April 2011)
are available at the conference hotel. Accommodation can
Platinum Package
2 day congress plus 2 workshops
Save € 290,- € 2.609,- +vAt € 2.899,- + vAt be booked by calling the central reservation number.
Gold Package Please always quote the booking reference IQPC-Berlin.
2 day congress plus 1 workshop
Save € 260,- € 2.339,- +vAt € 2.599,- + vAt
Hotel accommodation and travel costs are not included
Bronze Package
2 day congress
€ 2.199,- + vAt in the registration fee.
Workshop Day € 1.399,- + vAt
Please indicate choice of workshop on Monday, 4 July 2011
For further information please
Workshop A I Workshop B I Workshop C I Workshop D
visit our website www.authentication-pharma.com/MM
A: EU Falsified Medicines Directive – How much security/safety will be achieved?
B: Contractual relationships with suppliers regarding the subject of counterfeiting
or contact Kai Dodschat on +49 (0)30 20 91 32 74 or
C: Implementation of serialization and product tracking email eq@iqpc.de
D: Corporate Security Anti-Counterfeiting Strategies
Only one discount applicable per person.
CAN'T MAKE IT TO THE CONGRESS? PURCHASE THE 2-DAy CONGRESS DOCUMENTATION FOR € 595,- +vAt. Team Discounts
Delegate Details Please fill out in Capitals! We are offering attractive Team Discounts, please contact us!
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