2nd congress Global Pharma Authentication 2011

Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies – Business value and cutting cost

Global PharmaAuthenticAtion 2011

To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.authentication-pharma.com/MM

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the 29 April 2011!

Hear international top-level speakers from:

• European Commission

• Roche Pharma GmbH

• Novartis Pharma

• Pfizer GmbH

• MEDA Pharma GmbH & Co. KG

• PAREXEL International GmbH

• German Pharmaceutical Industry Association BPI e.V.

• University of Hamburg

• GS1 Germany

• TFH Wildau – University of Applied Science

• Quality Association for Pharmaceutical Packaging QAPP

• National Agency for Food and Drug Administration and Control NAFDAC, Nigeria

• European Association of Pharmaceutical Full-line Wholesalers GIRP

• Europol

• Eurojust

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2nd Congress

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

C: Implementation of serialization and product tracking

D: Corporate Security Anti-Counterfeiting Strategies

• Hear first hand updates on EU Falsified Medicines Directive and its impact on the fight against counterfeiting

• Gain practical insights into the methods applied by national and international investigative authorities in the fight against counterfeits

• Understand the methods and procedures of counterfeiting and how to apply counter-actions

• Learn about combining secure identification systems such as RFID and 2D Data Matrix to improve packaging security

• Improve the supply chain on several levels to ensure a secure and compliant product supply chain

Menno Vlietstra, Head Supply Chain IT, Roche Pharma GmbH

Kerstin Schrade-Butscher, Intelligence Analyst, Pfizer GmbH/Global Security

Dr. Paul B. Orhii, Director General, NAFDAC

Michael Ritter, Project Manager Serialization & Product Tracking, Novartis Pharma

Bérengère Dreno, Junior specialist, Operational department, Europol

Benefit from the following experts including:

4 – 6 July 2011 | Steigenberger Hotel, Berlin

Visit our download center for free white papers, articles and much more! www.authentication-pharma.com/MM

Dear Colleagues,

The production and trade of forged medicines is a growing illegal business worldwide. Counterfeit medicine poses a public health risk because their content can be dangerous, often lacking active ingredients. Their use 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 companies the loss of income and loss of branding reliability can be financially devastating. Additionally anti-counterfeiting measure and strategies can be cost-intensive – however, way are becoming more and more important..

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.

Join our international

2nd Congress

Global Pharma Authentication 2011Legislative & Regulatory Infrastructure – Anti-Counterfeiting Technologies –

Business value and cutting cost

Congress days 5 – 6 July 2011 Workshops 4 July 2011

Steigenberger Hotel Berlin, Germany

Benefit from expert opinions and

• Ensure industry collaboration in the fight against ‘online pharmacies’ and use of internet to purchase illegal medicines

• Implement Serialisation and Product Tracking successfully to protect patient safety

• Discuss new technology developments and the impact on pharmaceutical anti-counterfeiting

• Discover Nigeria‘s multi-layered approach to fight against counterfeit drugs

Save your place and book now! We look forward to meeting you in Berlin!

Kind regards,

Monica Wick Project Manager

Sponsorship

We have a variety of packagesavailable to suit your requirements. For all Sponsorship and Exhibitionopportunities call Catharina Piehler: +49 (0)30 20 91 32 75 or email [email protected]

Our Sponsor

Bluhm Systeme GmbHMaarweg 3359619 RheinbrettbachGermany+49 (0)2224 7708 7100+49 (0)2224 7708 [email protected]

For further information

Please visit our websitewww.authentication-pharma.com/MM or contact Kai Dodschat on +49 (0)30 20 91 32 74 or email [email protected]

Team DiscountsWe are offering attractive TeamDiscounts, please contact us!

Global Pharma AuthenticAtion 20112nd Congress


4 – 7 July 2011 | Steigenberger Hotel, Berlin


Register for our email updates!

Get the latest news on our events,additional download possibilities,early bird deadlines and much more!Register now at www.authentication-pharma.com/MM

Get free white papers, articles and much more! www.authentication-pharma.com/MM

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 your online portal to expand your knowledge and add value to your business.

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 [email protected]!

Who will you meet?

Global heads, directors and project managers of the following departments

• Supply chain • Anti-counterfeit strategies• Packaging & Labelling• Regulatory Affairs/Corporate Security/

Brand Protection



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

A: 09:30 – 13:00 | EU Falsified Medicines Directive – How much security/safety will be achieved?

INTERACTIVE WORKSHOP DAy | Monday, 4 July 2011


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)

B: 09:30 – 13:00 | Contractual relationships with suppliers regarding the subject of counterfeiting

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

C: 14:00 – 17:30 | Corporate Security Anti-Counterfeiting Strategies

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 sation and track & trace successfully.

• mass Serialisation & Data matrix Code• Development in europe and north America• 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

D: 14:00 – 17:30 | Implementation of serialization and product tracking

Highlight

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CONGRESS DAy ONE | Tuesday, 5 July 2011


09:30 Registration with coffee and tea

09:55 Chairman’s welcome & opening addressThomas Brückner, Head of Pharmaceutical Affairs/CAM/Medical Devices,German Pharmaceutical Industry Association (BPI e.V)

Global legislative and regulatory infrastructure

10:00 EU anti-counterfeit legislation and the German Pilot project• Current European legislation (Dir. 2001/83/EC)• implementation into german Law• Coding – Technical Details• German Pilot Projekt• OutlookThomas Brückner, Head of Pharmaceutical Affairs/CAM/Medical Devices,German Pharmaceutical Industry Association (BPI e.V)

10:45 Nigeria‘s multi-layered approach to fight against counterfeit drugs• Safeguarding Public Health• Cutting Edge Technologies• Advancement of regulatory oversight• widespread and cost effective method of nAfDAC

control• Cooperation and partnerships with technology providers,

private sector companies, law enforcement, customs and the media

Dr. Paul B. Orhii, Director General, National Agency for Food and Drug Administration and ControlNAFDAC

11:30 Refreshment break & networking

12:00 Fake medicines and serious & organised crime• The opinion of an expert• Scope of fake medicines (counterfeiting and falsified)• Transborder crime, serious and organised crime• Domestic and European framework• Law enforcement cooperationChristian Tournie, Seconded National Expert (counter-feiting, fake medicines, financial investigation), (TBC), European Commission – DG Home Affairs – Unit Fight Against Organised Crime

12:45 Europol and the fight against fake pharmaceuticals• General overview of Europol• Scope of the phenomenon of fake medicines• The fight against fake medicines on a multi-agencies

level• Cooperation between Europol and private sector• Case studiesBérengère Dreno, Junior specialist – Criminal finances and technology unit – Operational department, Europol

13:30 networking Luncheon

15:00 Fake medicine crime – role of EUROJUST in combating serious crime• Fake medicine crime (case example) • Cross border investigation• Problems on the judicial level • Added value of using EUROJUST• ConclusionsBenedikt Welfens, Deputy to the National Member for Germany, Eurojust

15:45 Falsified Medicines – liability and legal measures in Europe• Criminal, strict and tort liability for falsified medicinal

products• EU Proposal on legal improvements – Safety features – Strengthened requirements as to control and

inspection of APIs – Reporting duties – Trust mark for the internet selling• Quality risk management as to packaging, design and

labellingDr. Martin Wesch, Executive Secretary, Quality Association for Pharmaceutical Packaging (QAPP)


17:00 The Distributor’s responsibilities• Distribution and wholesale are critical elements of s upply• EU Directive will place significant responsibilities on

these activities in order to preserve the integrity of the supply chain

• What will be required and how can these supply chain actors ensure that Europe moves seamlessly towards the new legislative framework?

Martin Fitzgerald, Legal Director, European Association of Pharmaceutical Full-line Wholesalers (GIRP)

17: 45 Closing remarks of the chairman and end of day one

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Contact Catharina Piehler for more information: +49 (0)30 20 91 32 75 or email [email protected]

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Case Study

Regulatory Authority

Case Study

EU Directive

European Commission

Insight Eurojust

EU Legal Measures

Distributor’s Point

of View

Highlight

Highlight

Highlight



8:30 Registration with coffee and tea

8:55 Chairman’s welcome & opening address

Best Practices Serialization, Product Tracking & Anti-Counterfeiting

9:00 Counterfeit pharmaceuticals – a threat to patients health and safety• Scope of the problem• oLPs and b2b• Pfizer security features• Pfizer/Le investigations Kerstin Schrade-Butscher, Intelligence Analyst, Pfizer GmbH/Global Security

09:45 Cost effective Anti-Counterfeiting enforcement program• Control of suppliers to prevent distribution of material

produced for the originator into illegal traffic• Measures to prevent the infiltration of falsified raw

materials into the supply chain • Identifiers allowing to distinguish between original and

falsified products• Tamper evident product design to allow easy identifica-

tion of manipulations• Labelling/markers to allow product tracking in the

distribution chain• Implementation of IT infrastructure to support the

product tracking• Information exchange with customs, police, public

prosecutors offices• Modification of the processes to check compliance of

re-packaging/re-labelling by parallel importersHorst Kastrup, Senior Regulatory Advisor, MEDA Pharma GmbH & Co. KG


11:00 The Roche Global Supply Chain Strategy to reduce risk• Strategic context and program set up• Deliverables so far• First pilots• Potential other business benefitsMenno Vlietstra, Head Supply Chain IT, Roche Pharma GmbH

11:45 Implementation of Serialisation and Product Tracking project at Novartis Pharma Beijing• Project scope• Challenges• Lessons learnt• OutlookMichael Ritter, Project Manager Serialization & Product Tracking, Novartis Pharma

12:30 networking Luncheon

14:00 Counterfeit medication in clinical trials• Why is there a risk?• How to reduce the risk?• Serialization/track & trace in Clinical trials?Heidemarie Thorwartl, Sr. Manager OpsqM, PAREXEL International GmbH

14:45 Encreasing Supply Chain Quality with Track & Trace• Overview of GS1 standards for optimizing supply chain

processes• track & trace vs. Serialization • Benefits of Traceability solutions• How does Traceability work?• Concepts of Information sharingMichaela Hähn, Senior-Projektmanager, GS1 Germany


16:00 Panel Discussion: Harmonized product tracking for the EU & North

America – How realistic is a consistent approach and how successful would it be? • The European and the American approach – Differences

and similarities• Steps to be taken to a harmonized system – Is it worth

the effort?• Comparing the status quo of implementation – Who

ever goes first gets to decide?Speakers of the day

16:45 Product security in parallel distribution – A pilot project of the reimport industry to connect to European verification systems• Regulatory framework and practice ensuring product

safety in parallel distribution• EAEPC initiatives to supply chain safety• First learnings from a pilot project connecting re-import

to the Aegate system of authentication/verificationDr. Heinz Kobelt, Secretary General, EAEPC

17:30 Closing remarks of the chairman and end of congress day two

CONGRESS DAy TWO | Wednesday, 6 July 2011


IQPC provides business executives around the world with tailored practical congresses, large scale events, topical seminars and in-house training programs, keeping them up-to-date with industry trends, technological developments and the regulatory landscape. IQPC’s large scale congresses are market leading “must attend” events for their respective industries. IQPC produces more than 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, Singapore, Stockholm, Sydney and Toronto. IQPC leverages a global research base of best practices to produce an unrivalled portfolio of congresses. www.iqpc.de

Case Study

Case Study

Case Study

Case Study

Case Study

Case Study

Parallel Distributor’s Pilot Project

Global PharmaAuthenticAtion 2011

2nd Congress

4 – 6 July 2011 I Steigenberger Hotel Berlin

Kai Dodschat #GTS/KDO

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Please indicate choice of workshop on Monday, 4 July 2011Workshop A I Workshop B I Workshop C I Workshop D

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A: EU Falsified Medicines Directive – How much security/safety will be achieved? B: Contractual relationships with suppliers regarding the subject of counterfeitingC: Implementation of serialization and product trackingD: Corporate Security Anti-Counterfeiting Strategies

Team DiscountsWe are offering attractive Team Discounts, please contact us!

For further information pleasevisit our website www.authentication-pharma.com/MMor contact Kai Dodschat on +49 (0)30 20 91 32 74 or email [email protected]

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2nd congress Global Pharma Authentication 2011