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2nd congress Global Pharma Authentication 2011


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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.

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2nd congress Global Pharma Authentication 2011

  1. 1. up rly e Ea SA to rd A € s pr Bi 29 29 if il th V 0, yo 20 - € u 11 e w bo ! ith ok ou by r 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! 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 StrategiesTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E |
  2. 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 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 • 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, Team Discounts We are offering attractive Team For further information Monica Wick Discounts, please contact us! Project Manager Please visit our website or contact Kai Dodschat on +49 (0)30 20 91 32 74 or email 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! 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 Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E |
  3. 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: 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 ScienceTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E |
  4. 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 expertCommission • 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 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 EuropolTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E |
  5. 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.deTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E |
  6. 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: If undeliverable, please return to: Email: 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 Email: yOUR DETAILS: PLeASe ContACt ouR DAtAbASe mAnAgeR (veRteiLeR@iQPC.De) AnD infoRm them of Any inCoRReCt 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 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 D: Corporate Security Anti-Counterfeiting Strategies Only one discount applicable per person. CANT 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! DELEGATE Mr Mrs Ms Dr family name  first name Payment Terms Position Email Telephone Fax Payment is due on receipt of the invoice. Organisation Address Cancellations and Substitutions CANCELLATIONS AND SUBSTITUTIONS DeLegAteS  mAy  be  SubStituteD  At  Any  time.    iQPC  geSeLLSChAft  füR  Postcode/Town mAnAgement  KonfeRenzen  mbh  DoeS  not  PRoviDe  RefunDS  foR CAnCeLLAtionS.  howeveR, SAve wheRe wRitten notiCe of CAnCeLLAtion Approving Manager: iS ReCeiveD moRe thAn Seven (7) DAyS PRioR to the CongReSS, A CReDit  to the  vALue  PAiD  At thAt  DAte  wiLL  be  iSSueD,  whiCh  mAy  be  uSeD  Signature AgAinSt  AnotheR  iQPC  gmbh CongReSS  foR  uP  to  one  yeAR  fRom  ITS DATE OF ISSUE. 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