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  • Supporting Organisations:ECA

    E CUROPEAN OMPLIANCEACADEMY

    SPEAKERS:

    Andrea K Brunson, Pfizer, USA

    Andy Charvill, MHRA, UK

    Dr Domenico Di Giorgio, Agenzia Italiana del Farmaco, Italy

    Michaela Hhn, GS1 Germany GmbH

    Prof. Dr. Ulrike Holzgrabe, University of Wrzburg, Germany

    Karl Metzger, Welding GmbH & Co. KG, Germany

    Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands

    Geoff Power, Former Director of Packaging Security, GlaxosSmithKline, UK

    Robert Rosito, Essex Animal Health, Germany

    Michael S. Russo, Eli Lilly & Company, USA

    Dr. Stephan Schwarze, Bayer Schering Pharma AG, Germany

    Prof Dr Klaus-Jrgen Steffens, University of Bonn, Germany

    Harald Vogt, SAP AG, Germany

    Dr. Martin Wesch, Wesch & Buchenroth, Germany

    Strategies againstCounterfeit MedicinesImplementation of Counterfeit Protection Systems in the Pharmaceutical Industry

    3-5 November 2008, Wrzburg near Frankfurt, Germany

    HIGHLIGHTS:

    Tryptophan, Gentamicin, Heparin

    What Will Happen Next?

    Worrying Trends in Europe and USA

    Anti-Counterfeit Activities by Regulatory Agencies WHO IMPACT Taskforce Different Approaches and Projects in Europe The MHRA Anti-Counterfeit Strategy FDA Activities

    Industry Initiatives: EFPIAs Proposal for Coding and Identification 2 D Data Matrix Code

    RFID

    Security Features for Packaging Materials

    The Invisible Danger of Rogue APIs

    Holistic Approach for Counterfeit Protection

    Management

    Challenges for Supply Chain Trader / Distributor Pharmaceutical Industry

    The Heparin Case Legal Implications for QA and QPs

  • Invitation by the University of Wrzburg

    Dear Colleagues,

    Due to the progressing globalization counter-feit drugs become more and more an issue. Active pharmaceutical ingredients and excipi-ents are no longer produced in the pharma-ceutical companies who are the innovators of

    the drugs. The production sites of the APIs and formulat-ed products are often in China and India. Customs all over the world fish illegally produced drugs out more fre-quently. Drugs are increasingly sold via the internet which makes it much easier to put counterfeits into cir-culation.

    Thus, strategies against counterfeited APIs become more important. Hence, we put a program together dealing with the implementation of counterfeit protection strate-gies and systems. Experts from USA and Europe, and from different institutions of both industries and regula-tory authorities will be present for discussions and ex-change of experiences on the various aspects of anti-counterfeiting activities.

    It will be a great pleasure for me to welcome you in Wrzburg on behalf of the Institute of Pharmacy and Food Chemistry of our university.

    Prof. Dr. Ulrike HolzgrabeChair of Pharmaceutical ChemistryUniversity of Wrzburg

    Target Audience

    This conference is intended for people working in

    Packaging DevelopmentR&DManufacturing / PackagingQuality Assurance / Quality Control (QPs)Purchasing and Materials ManagementRegulatory AffairsCounterfeit Protection Management

    of pharmaceutical, biopharmaceutical and API companies.

    The conference is also intended for members of national or international authorities and for personnel working in Security Technology, and Packaging Components or La-beling companies.

  • This conference is supported by

    The University of WrzburgWith over 600 years of tradition, the Julius Maximilian University of Wrzburg is today one of Germanys mid-sized universities. 400 professors in 10 faculties here teach roughly 20,000 students.

    The University of Wrzburg is among the leading institutions of higher education in Germany; this has been confirmed by rankings carried out by national and international research organizations, international external assessment committees as well as by the German Federal and State Excellence Initiatives (founded in 2006). Internationally, the University of Wrzburg is also one of the top-ranking academic institutions in many fields of research and study.

    The German Pharmaceutical Society (Deutsche Pharmazeutische Gesellschaft)The German Pharmaceutical Society (DPhG), founded in 1890 in Berlin, is one of the oldest German scientific societies (9.000 members). The aims of the DPhG are to promote the pharmaceutical sciences and interdisciplinary way of thinking, to encourage junior scientists within the pharma-ceutical community, to maintain contact with foreign scientists and with foreign special societies, to facilitate transfer of new scientific knowledge into pharmacy practice, to advise legislative and administrative bodies on pharma-ceutical matters and to establish position statements on pharmaceutical questions of public interest.

    FECC (European Association of Chemical Distributors)The European Association of Chemical Distributors (FECC) represents around 1,200 European chemical distributors. FECC Members, many of which are SMEs, create value in the supply chain meeting the demands of over one million downstream users. Several of these members distribute excipients and Active Pharmaceuticals Ingredients to manufacturers of medicinal product throughout Europe. Chemical distributors play a vital role in the pharmaceutical supply chain.

    FECC promotes the implementation of the WHO Good Trade and Distribution Practices for Pharmaceutical Starting Materials (GTDP) for all excipients. This commitment to GTDP is the chemical distributions contribution to reduce and manage the risks involved in supplying pharmaceutical starting materials to finished dosage form manufacturers.

    The European QP AssociationThe Qualified Person Association was founded on 7 July 2006 with the objective to represent the Qualified Persons in Europe. Within only 10 weeks, more than 350 QPs and individuals preparing to become a QP from all over Europe already signed up for membership. The members represent all major pharmaceutical companies as well as small and medium-sized businesses.

    In addition to QPs from EU member states, QPs from EU member candidates and proposed candidates can also become members/associate members. Guest and Ob-server are additional membership status levels available to applicants from other countries who may be involved in the certification and batch release of medicinal products.

  • Objectives

    The aim of this conference is to present both the regula-tory authorities activities and the pharmaceutical indus-trys activities to develop and establish appropriate coun-terfeit protection systems. The conference will focus on effective and affordable strategies, improve collaboration among regulators and pharmaceutical industry, and dis-cuss actions in the global fight against counterfeit.

    Background

    Counterfeit medicines represent an enormous public health challenge today. WHO estimates that around 1% of sales in developed countries to over 10% in develop-ing countries are counterfeited and that counterfeit drugs are increasingly present even in better controlled mar-kets.

    More recently the European Commission stated that a recent analysis of the present situation has revealed that counterfeit medicines have become an increasing threat to public health over the past few years. The Commis-sion has observed the following worrying trends in par-ticular:

    a sharp increase in seized counterfeit medicinesa trend towards counterfeiting of life-saving drugs (not only lifestyle medicines)a trend towards targeting the classical supply chaina blurred line between counterfeit and sub-standard ac-tive substances in medicinal products

    The FDA has just requested comments and information regarding standards and technologies used for the iden-tification, validation, tracking and tracing , and authenti-cation of prescription drugs. Particularly, they were re-questing information and comments from drug manufacturers, distributors, pharmacies, other supply chain stakeholder, foreign regulators, standard organiza-tions and other interested parties for the purpose of se-curing the drug supply chain against counterfeit, divert-ed, subpotent, substandard, adulterated, misbranded, or expired drugs.

    Moderator

    Prof. Dr. Ulrike HolzgrabeUniversity of Wrzburg, Germany

    Programme Tryptophan, Gentamicin, Heparin What Happens Next?

    Different forms of counterfeitingRepresentative casesProduction in China and IndiaControl of the supply chainDrugs and Internet

    Prof Dr Ulrike Holzgrabe, University of Wrzburg

    The WHO Global Anti-counterfeiting Taskforce - IMPACT

    How the IMPACT task force is working to coordinate the different stakeholders in the fight against counterfeiters

    Dr Domenico Di Giorgio, Italy

    Anti-Counterfeit Activities by European Regulatory Agencies

    Different approaches and running projects in Europe, as a consequence to the IMPACT and CoE initiatives

    Dr Domenico Di Giorgio, Italy

    The MHRA Anti-counterfeit Strategy and the Role of the Laboratory

    Combating counterfeit MedicinesEnforcement and IntelligenceWatch listSupply Chain and Due DiligenceLaboratory Confirmation of counterfeitsGood Manufacturing PracticeComparison with Authentic ComparatorsNear Infrared SpectroscopyChromatographic techniques

    Andy Charvill, MHRA, UK

    Activities of the Pharmaceutical Industry in Europe - EFPIAs Proposal for Coding and Identification

    Current coding situation in EuropeConcept of the proposal2D Matrix Code as coding solutionProperties (cost, systems critical requirements, stakehold-er alignment, time line) of the proposalEnvisaged pilot project

    Dr Stephan Schwarze, BayerHealthCare, Germany

    US Based Counterfeit Pharmaceutical InvestigationsKey strategies for the investigatio

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