strategies against counterfeit medicines · counterfeit medicines implementation of counterfeit...
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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 Hähn, GS1 Germany GmbH
Prof. Dr. Ulrike Holzgrabe, University of Würzburg, 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-Jürgen 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, Würzburg 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: EFPIA’s 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 Würzburg
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 Würzburg on behalf of the Institute of Pharmacy and Food Chemistry of our university.
Prof. Dr. Ulrike HolzgrabeChair of Pharmaceutical ChemistryUniversity of Würzburg
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 WürzburgWith over 600 years of tradition, the Julius Maximilian University of Würzburg is today one of Germany‘s mid-sized universities. 400 professors in 10 faculties here teach roughly 20,000 students.
The University of Würzburg 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 Würzburg 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 distribution’s 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-try’s 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 Würzburg, 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 Würzburg
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 - EFPIA‘s 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 investigation of counterfeit pharma-ceuticals by non government entitiesHow to develop working relationships with US law en-forcement authoritiesWhat law enforcement authorities need when you ask for their assistanceUnderstanding the various jurisdictions of US law en-forcement and regulatory agencies who have the ability to enforce laws and regulations involving counterfeit phar-maceuticals
Michael S. Russo, Eli Lilly & Company, USA
Strategies against Counterfeit Medicines 3-5 November 2008, Würzburg, Germany
Rogue APIs: The Invisible DangerDefinitionsHistory of the issue and role of CEFICWeaknesses in authority oversightHeparin and other example casesImpact on human healthSolutions to the problem
Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands
Counterfeit Protection Management – Holistic Approach as Strategy
Conceptual model forms the basis for strategic thoughtsAnti-Counterfeiting Safety Chain - It is about defense and attackKnowledge - About Motivators for Supply and DemandPrevention - No single isolated but combined measuresReaction - Preparedness in different areas is the keyMonitoring - Data: collection - evaluation - assessment to actContinuous Learning - Basic rule to keep pace
Dr Stephan Schwarze, BayerHealthCare, Germany
Lessons Learnt from the Heparin Case – Legal Implica-tion for Quality Assurance Personnel and/or QPs
Liability of– Counterfeiter– Pharmaceutical Manufacturer– QP and – Quality Assurance PersonnelInsurabilityImprovement opportunities
Dr Martin Wesch, Wesch & Buchenroth, Germany
The EU-Funded Research Project SToP: Prototyping an Anti-Counterfeiting Infrastructure
Presentation of elements from a business and system in-frastructure that allows brand owners to protect their products down to the item levelHardware, software, and business process issuesRule-based authentication based on identifiers onlyIntegration of RFID and other authentication techniquesResults obtained from a prototyping project that involves partners from different industries, including the pharmaceutical industry represented by Novartis
Harald Vogt, SAP AG, Germany
Trader’s/Distributor’s Part in the Control of the Supply Chain
Activities of Traders/DistributorsFECC’s Position regarding Counterfeit Medicinal Prod-ucts/ WHO Guideline ‘Good Trade and Distribution Prac-tice of Pharmaceutical Starting Materials’Challenges in the Supply ChainHow to prevent to become Prey of Counterfeiting
Karl Metzger, Welding GmbH & Co. KG, Germany
Auditor’s Strategy to Detect Counterfeiting Activities Preparation of the auditSome real casesAuditing StrategyFollow-up
Karl Metzger, Welding GmbH & Co. KG, Germany
Supply Chain SecurityGS1 Germany Overview of GS1 standards for optimizing supply chain processesMass serialisation against counterfeitingTechnical aspects of mass serialisationData contentData carrierCommunication networkApproaches in the pharmaceutical industry
Michaela Hähn, GS1 Germany GmbH, Germany
RFID – Current Applications and Future PerspectivesPfizerUS, PedigreeSerializationTrack and Trace2D Bar CodesLogistics efficiency
Andrea K. Brunson, Pfizer, USA
Implementation of EAN Data Matrix Code - Experi-ences of the Veterinary Pharmaceutical Industry
Regulations, what was the reason for the implementation?Organization and DefinitionsPrinting methods, selection of adequate systemsCode quality controls, assurance of machine readabilityProblems and solutionsRecommendations
Roberto Rosito, Essex Animal Health, Germany
Counterfeit Drugs and the Fast and Reliable Way for their Identification by XRD
X-ray diffractionNon-destructive analysisPolymorphismAPIExcipientBlisterSynthetic drugs
Prof Dr Klaus-Jürgen Steffens, University of Bonn, Germany
Authentication Technologies - Some Insights and Options
The role of Technology in the war against counterfeits – prevention or authentication? Overt or covert?The WHO Impact paper on Anti-counterfeit Technologies – are there any silver bullets? Mass Serialisation – can it be mandated?The manufacturers’ perspective – formulating a strategyCost versus benefits, or risk management?
Geoff Power, Former Director of Packaging Security, GlaxosSmithKline, UK
Speakers
Andrea K. Brunson, Pfizer, USAAndrea K. Brunson began her Pfizer career in September, 2003, as logistics engineer in Pfizer’s US Market Logistics group in Memphis, TN. She is currently Senior Manager of the Planning team with America’s Market logistics group.
Andrea earned a Bachelor of Science in Mechanical Engineering degree in 1999 from The University of Wisconsin. Prior to joining Pfizer, Andrea worked for a leading consulting firm specializing in Retail Distribution. She currently lives in Collierville, Tennessee
Andrew John Charvill, Analytical Assessor, Medicines Testing Scheme, MHRA, UKAndy Charvill is a chemist by training and has worked at the Medicines and Healthcare products Regulatory Agency (MHRA, the UK Competent Authority) as the Analytical
Assessor for the Medicines Testing Scheme (MTS), since 1994. Prior to this Andy was employed in a variety of Quality Control/Quality Assurance positions in the Pharmaceutical Industry, principally in the manufacture of Large Volume Parenterals.
Dr Domenico Di Giorgio, Senior Chemist Officer, Anti-counterfeiting Activities Manager Agenzia Italiana del Farmaco, Roma, ItalyDr. Di Giorgio is coordinator and member of the organiz-ing committee of the AIFA-WHO international conference
“Combating Counterfeit Drugs” (Rome, 2006); Italian member of IMPACT, and Chairman of the EDQM/CoE “Committee of experts on minimising public health risks posed by counterfeiting of medical products and related crimes”.
Michaela Hähn, GS1 Germany GmbH, Cologne, GermanyMichaela Hähn joined GS1 Germany, the German EAN organisation, in 1998. She is currently Senior Project Manager AIDC (Automatic Identification and Data Capture). Responsible for the development of new AIDC
standards, Michaela is engaged in work on anti-counterfeiting concepts, as well as GS1 Healthcare, the global initiative of GS1 and the healthcare industry to improve patient safety.
Prof Dr Ulrike Holzgrabe, University of Würzburg, Würzburg, GermanyUlrike Holzgrabe holds a chair in Pharmaceutical Chemis-try at the University of Würzburg and is a member of several national an international committees dealing with
the German and European Pharmacopoeia. Thus, she is interested in modern analytical methods for quality assurance of drugs.
Karl Metzger, Welding GmbH & Co. KG, Hamburg, GermanyKarl Metzger works with Welding GmbH & Co. KG in Hamburg as Management responsible for the company’s integrated Management System and is deputy QP for APIs and coordinates Welding’s auditing activities. He is
member of FECC’s ’Good Trade and Distribution Committee’. Further-more Karl is APIC certified ICH Q7 Auditor and has more than 10 years experience in global auditing of chemical, biotechnological and pharmaceutical manufacturers.
Dr Chris Oldenhof, DSM Anti-Infectives, Delft, The NetherlandsChris Oldenhof holds a Ph.D. in organic chemistry. He is currently Manager External Regulatory Affairs at DSM Anti-Infectives, Delft, The Netherlands. In his 29 years with DSM
he has held positions in R&D, Marketing & Sales and Regulatory Affairs. Within CEFIC (the European Chemical Industry Council) he is President of APIC (Active Pharmaceutical Ingredients Committee) and a Board Member of the EFCG (European Fine Chemicals Group). In addition he is a member of the Council of Europe’s ad hoc Group on Counterfeit Medicines since 2003.
Geoff Power, Packaging Security Specialist, Former Director of Packaging Security, GlaxoSmithKline, UKGeoff has some 35 years’ experience in Packaging Technol-ogy, including 22 years with GlaxoSmithKline. Geoff recently retired as Director of Packaging Security for GSK where he
provided a packaging support service to the GSK group world-wide. His responsibilities included maintaining the security and integrity of healthcare packaging operations, and developing a corporate protective strategy against counterfeiting and adulteration. He set up a centralised forensic examination service for suspect packs, and was responsible for developing anti-counterfeit measures. Geoff was Technical Advisor to the Pharmaceutical Security Institute, and authored a technology briefing paper for WHO IMPACT.
Roberto Rosito, Essex Animal Health Friesoythe, GermanyRoberto Rosito has more than 22 years experience in pharmaceutical production. He worked as Production Manager and Plant Manager at Hoechst’s subsidiary pharmaceutical plant in Guatemala City and at Astrid
Twardy’s and Pharmapack’s pharmaceutical plants in Germany. Since 2003 he has been working as Project Manager at Essex Animal Health Friesoythe a Division of Essex Pharma GmbH, responsible for installa-tion and operational qualification projects, conceptual design of equipments and process optimization.
Michael S. Russo, Eli Lilly & Company, USAMichael S. Russo joined Lilly in 1997. He is a global security manager for Eli Lilly and Company based in Indianapolis, Indiana USA. He is responsible for the management of Lilly’s Global Product Protection Security Team which
includes eight (8) experienced investigators based in Asia, Europe and the US who handle cases involving counterfeit, stolen and diverted pharmaceuticals. His responsibilities also extend to general security support for Lilly affiliates outside the United States.
Dr Stephan Schwarze, Bayer Schering Pharma AG, Berlin, GermanyStephan Schwarze started his career at Schering AG Berlin in 1992 and is now heading the function Counterfeit Protection Management since 2005. First within Schering
AG Berlin and nowadays within Bayer Schering Pharma AG. He is a member of WHO IMPACT‘s Technology Subgroup as well as of EFPIA‘s Anti-Counterfeiting ad hoc working group.
Prof Dr Klaus-Jürgen Steffens, University of Bonn, GermanyKlaus-J. Steffens holds a chair in Pharmaceutical Technol-ogy at the University of Bonn. He is an expert in the development and production of solid dosage forms. The physicochemical characterization of raw materials and
final products is one of his most important research fields with more than 20 years experience in special analytical tools, among them spectroscopic methods like NIRS and XRD.
Harald Vogt, Senior Researcher, SAP AG, Karlsruhe, GermanyHarald Vogt holds a degree in computer science and is technical project manager for SToP at SAP Research. He has experience in the areas of security, RFID, and ubiquitous computing.
Dr Martin WESCH, Lawyer at Wesch & Buchenroth, Stuttgart, GermanyDr Martin Wesch is a lawyer specialising in medical and industrial law and working for the Stuttgart-based firm of lawyers Wesch & Buchenroth, which he founded in 2001.
Since April 2002, he has been teaching industrial law at the University of Stuttgart. Since 1994, Martin Wesch is Managing Director of the Gütegemeinschaft Pharma-Verpackung e.V., a quality association for pharmaceutical packaging.
Date
Monday, 3 November 2008, 09:00 – 18:00 h (Registration and coffee 08:00 – 09:00 h)Tuesday, 4 November 2008, 08:30 – 18:00 h Wednesday, 5 November 2008, 08:30 – 15:30 h
Venue
Maritim Hotel WürzburgPleichertorstr. 597070 WürzburgGermanyTel.: ++ 49 / (0) 931 / 3053-0Fax: ++ 49 / (0) 931 / 3053-900 / -901
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the event hotel. You will receive a room res-ervation form when you have registered for the event. Please use this form for your room reservation or be sure to mention “CON0211” to receive the specially negotiat-ed rate for the duration of your stay. Reservation should be made directly with the hotel not later than 22 Septem-ber 2008. Early reservation is recommended.
Fees
Non-ECA Members EUR 1,990.- per delegate plus VATECA Members EUR 1,791.- per delegate plus VATFECC Members EUR 1,791.- per delegate plus VATAPIC Members EUR 1,890.- per delegate plus VAT(does not include ECA Membership)EU GMP Inspectorates EUR 995.- per delegate plus VATThe conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Registration
Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.
Conference language
The official conference language will be English.
Social Event
On the evening of the first conference day, you are cor-dially invited to a social event in the historical city of Wurzburg. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Würzburg – Accessibility via Frankfurt Airport
The transfer from Frankfurt Air-port to Würzburg is rather con-venient:
1. By Bus ShuttleThere will be a bus shuttle free-of-charge available on Sunday, 2 November 2008, from Frank-furt Airport to the Maritim Ho-tel Würzburg at 18.00 h and
21.00 h. Travelling time approx. 2 hours
On Wednesday, 5 November 2008, buses will transfer for Frankfurt Airport directly after the end of the confer-ence. Travelling time: approx. 2 h.
2. By TrainAlternatively, there is a direct 1h 30 min train connection from Frankfurt Airport to Würzburg Main Station.
Organisation and Contact
CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 HeidelbergPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34E-mail: [email protected]
For questions regarding content:Dr Günter Brendelberger (Operations Director) at +49-6221/84 44 40, or per e-mail at [email protected] questions regarding reservation, hotel, organisation etc.:Ms Marion Weidemaier (Organisation Manager) at +49-6221/84 44 46, or per e-mail at [email protected].
About CONCEPT HEIDELBERG
Founded in 1978, CONCEPT HEIDELBERG is the leading organiser of seminars on pharmaceutical production, quality control, quality assurance and GMP in Europe. This year more than 240 events will be organised by CONCEPT HEIDELBERG. ECA has entrusted CONCEPT HEIDELBERG with the organisation of its events.
General Terms of Business
If you cannot attend the conference you have two options:1. We are happy to welcome a substitute colleague at any time.2. If you have to cancel entirely, we must charge the following processing fees: Cancellation
until 2 weeks prior to the conference 10 % of the registration fee.until 1 week prior to the conference 50 % of the registration fee.within 1 week prior to the conference 100 % of the registra-tion fee.
CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will not be responsible for discount airfare penalties or other costs incurred due to a cancellation. Terms of payment: Payable without deductions within 10 days after receipt of invoice.Important: This is a binding registration and above fees are due in case of cancellation or non-appearance. If you cannot take part, you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee even if you have not made the payment yet. You are not entitled to participate in the conference until we have received your payment (receipt of payment will not be confirmed)!
What Is ECA?
The European Compliance Academy (ECA) is an independent educational organisation chaired by a Scientific Advisory Board with members of the pharmaceutical industry and regulatory authorities. The ECA will provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances.
What Are the Benefits of ECA?
First benefit: During the membership, you enjoy a 10 % discount on the regular participation fee of any European Conference organised by ECA in co-operation with CONCEPT HEIDELBERG.
Second benefit: The GMP Guideline Manager CD ROM with a large number of guidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines, will be forwarded to you when you are using your membership for a conference registration.
How Do You Become Member of ECA?
By participating in one of the European Compliance Confer-ences or Courses marked with ECA, you will automatically become a member of ECA for two years – free of charge. There are no obligations for the member! Conferences and Education Courses organised by ECA will be realised in co-operation with CONCEPT HEIDELBERG. More information about ECA can be obtained on the Website http://www.gmp-compliance.org.
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