Strategies against Counterfeit Medicines

Transcription

1 Supporting Organisations: ECA EUROPEAN COMPLIANCE ACADEMY Strategies against Counterfeit Medicines Implementation of Counterfeit Protection Systems in the Pharmaceutical Industry 3-5 November 2008, Würzburg near Frankfurt, SPEAKERS: Andrea K Brunson, Pfizer, USA Andy Charvill, MHRA, UK Dr Domenico Di Giorgio, Agenzia Italiana del Farmaco, Italy Michaela Hähn, GS1 GmbH Prof. Dr. Ulrike Holzgrabe, University of Würzburg, Karl Metzger, Welding GmbH & Co. KG, Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands Geoff Power, Former Director of Packaging Security, GlaxosSmithKline, UK Robert Rosito, Essex Animal Health, Michael S. Russo, Eli Lilly & Company, USA Dr. Stephan Schwarze, Bayer Schering Pharma AG, Prof Dr Klaus-Jürgen Steffens, University of Bonn, Harald Vogt, SAP AG, Dr. Martin Wesch, Wesch & Buchenroth, 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

2 Invitation by the University of Würzburg Dear Colleagues, Due to the progressing globalization counterfeit drugs become more and more an issue. Active pharmaceutical ingredients and excipients are no longer produced in the pharmaceutical companies who are the innovators of the drugs. The production sites of the APIs and formulated products are often in China and India. Customs all over the world fish illegally produced drugs out more frequently. Drugs are increasingly sold via the internet which makes it much easier to put counterfeits into circulation. Thus, strategies against counterfeited APIs become more important. Hence, we put a program together dealing with the implementation of counterfeit protection strategies and systems. Experts from USA and Europe, and from different institutions of both industries and regulatory authorities will be present for discussions and exchange of experiences on the various aspects of anticounterfeiting 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 Holzgrabe Chair of Pharmaceutical Chemistry University of Würzburg Target Audience This conference is intended for people working in Packaging Development R&D Manufacturing / Packaging Quality Assurance / Quality Control (QPs) Purchasing and Materials Management Regulatory Affairs Counterfeit 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 Labeling companies.

3 This conference is supported by The University of Würzburg With over 600 years of tradition, the Julius Maximilian University of Würzburg is today one of 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 ; 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 pharmaceutical 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 pharmaceutical 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 Association The 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 Observer are additional membership status levels available to applicants from other countries who may be involved in the certification and batch release of medicinal products.

4 Strategies against Counterfeit Medicines 3-5 November 2008, Würzburg, Objectives The aim of this conference is to present both the regulatory authorities activities and the pharmaceutical industry s activities to develop and establish appropriate counterfeit protection systems. The conference will focus on effective and affordable strategies, improve collaboration among regulators and pharmaceutical industry, and discuss 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 developing countries are counterfeited and that counterfeit drugs are increasingly present even in better controlled markets. 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 Commission has observed the following worrying trends in particular: a sharp increase in seized counterfeit medicines a trend towards counterfeiting of life-saving drugs (not only lifestyle medicines) a trend towards targeting the classical supply chain a blurred line between counterfeit and sub-standard active substances in medicinal products The FDA has just requested comments and information regarding standards and technologies used for the identification, validation, tracking and tracing, and authentication of prescription drugs. Particularly, they were requesting information and comments from drug manufacturers, distributors, pharmacies, other supply chain stakeholder, foreign regulators, standard organizations and other interested parties for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs. Moderator Prof. Dr. Ulrike Holzgrabe University of Würzburg, Programme Tryptophan, Gentamicin, Heparin What Happens Next? Different forms of counterfeiting Representative cases Production in China and India Control of the supply chain Drugs 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 Medicines Enforcement and Intelligence Watch list Supply Chain and Due Diligence Laboratory Confirmation of counterfeits Good Manufacturing Practice Comparison with Authentic Comparators Near Infrared Spectroscopy Chromatographic techniques Andy Charvill, MHRA, UK Activities of the Pharmaceutical Industry in Europe - EFPIA s Proposal for Coding and Identification Current coding situation in Europe Concept of the proposal 2D Matrix Code as coding solution Properties (cost, systems critical requirements, stakeholder alignment, time line) of the proposal Envisaged pilot project Dr Stephan Schwarze, BayerHealthCare, US Based Counterfeit Pharmaceutical Investigations Key strategies for the investigation of counterfeit pharmaceuticals by non government entities How to develop working relationships with US law enforcement authorities What law enforcement authorities need when you ask for their assistance Understanding the various jurisdictions of US law enforcement and regulatory agencies who have the ability to enforce laws and regulations involving counterfeit pharmaceuticals Michael S. Russo, Eli Lilly & Company, USA

5 Rogue APIs: The Invisible Danger Definitions History of the issue and role of CEFIC Weaknesses in authority oversight Heparin and other example cases Impact on human health Solutions 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 thoughts Anti-Counterfeiting Safety Chain - It is about defense and attack Knowledge - About Motivators for Supply and Demand Prevention - No single isolated but combined measures Reaction - Preparedness in different areas is the key Monitoring - Data: collection - evaluation - assessment to act Continuous Learning - Basic rule to keep pace Dr Stephan Schwarze, BayerHealthCare, Lessons Learnt from the Heparin Case Legal Implication for Quality Assurance Personnel and/or QPs Liability of Counterfeiter Pharmaceutical Manufacturer QP and Quality Assurance Personnel Insurability Improvement opportunities Dr Martin Wesch, Wesch & Buchenroth, The EU-Funded Research Project SToP: Prototyping an Anti-Counterfeiting Infrastructure Presentation of elements from a business and system infrastructure that allows brand owners to protect their products down to the item level Hardware, software, and business process issues Rule-based authentication based on identifiers only Integration of RFID and other authentication techniques Results obtained from a prototyping project that involves partners from different industries, including the pharmaceutical industry represented by Novartis Harald Vogt, SAP AG, Trader s/distributor s Part in the Control of the Supply Chain Activities of Traders/Distributors FECC s Position regarding Counterfeit Medicinal Products/ WHO Guideline Good Trade and Distribution Practice of Pharmaceutical Starting Materials Challenges in the Supply Chain How to prevent to become Prey of Counterfeiting Karl Metzger, Welding GmbH & Co. KG, Auditor s Strategy to Detect Counterfeiting Activities Preparation of the audit Some real cases Auditing Strategy Follow-up Karl Metzger, Welding GmbH & Co. KG, Supply Chain Security GS1 Overview of GS1 standards for optimizing supply chain processes Mass serialisation against counterfeiting Technical aspects of mass serialisation Data content Data carrier Communication network Approaches in the pharmaceutical industry Michaela Hähn, GS1 GmbH, RFID Current Applications and Future Perspectives Pfizer US, Pedigree Serialization Track and Trace 2D Bar Codes Logistics efficiency Andrea K. Brunson, Pfizer, USA Implementation of EAN Data Matrix Code - Experiences of the Veterinary Pharmaceutical Industry Regulations, what was the reason for the implementation? Organization and Definitions Printing methods, selection of adequate systems Code quality controls, assurance of machine readability Problems and solutions Recommendations Roberto Rosito, Essex Animal Health, Counterfeit Drugs and the Fast and Reliable Way for their Identification by XRD X-ray diffraction Non-destructive analysis Polymorphism API Excipient Blister Synthetic drugs Prof Dr Klaus-Jürgen Steffens, University of Bonn, 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 strategy Cost versus benefits, or risk management? Geoff Power, Former Director of Packaging Security, GlaxosSmithKline, UK

6 Speakers Andrea K. Brunson, Pfizer, USA Andrea 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, UK Andy 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 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, Anticounterfeiting Activities Manager Agenzia Italiana del Farmaco, Roma, Italy Dr. Di Giorgio is coordinator and member of the organizing 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 GmbH, Cologne, Michaela Hähn joined GS1, the German EAN organisation, in 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, Ulrike Holzgrabe holds a chair in Pharmaceutical Chemistry 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, Karl 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. Furthermore 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 Netherlands Chris 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 Geoff Power, Packaging Security Specialist, Former Director of Packaging Security, GlaxoSmithKline, UK Geoff has some 35 years experience in Packaging Technology, 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, Roberto 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. Since 2003 he has been working as Project Manager at Essex Animal Health Friesoythe a Division of Essex Pharma GmbH, responsible for installation and operational qualification projects, conceptual design of equipments and process optimization. Michael S. Russo, Eli Lilly & Company, USA Michael S. Russo joined Lilly in 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, Stephan Schwarze started his career at Schering AG Berlin in 1992 and is now heading the function Counterfeit Protection Management since 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, Klaus-J. Steffens holds a chair in Pharmaceutical Technology 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, Harald 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, Dr 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 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.

7 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 Würzburg Pleichertorstr Würzburg Tel.: / (0) 931 / Fax: / (0) 931 / / -901 Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the event hotel. You will receive a room reservation 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 negotiated rate for the duration of your stay. Reservation should be made directly with the hotel not later than 22 September Early reservation is recommended. Fees Non-ECA Members EUR 1,990.- per delegate plus VAT ECA Members EUR 1,791.- per delegate plus VAT FECC Members EUR 1,791.- per delegate plus VAT APIC Members EUR 1,890.- per delegate plus VAT (does not include ECA Membership) EU GMP Inspectorates EUR per delegate plus VAT 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. 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 or by fax message. Or you register online at Conference language Würzburg Accessibility via Frankfurt Airport The transfer from Frankfurt Airport to Würzburg is rather convenient: 1. By Bus Shuttle There will be a bus shuttle freeof-charge available on Sunday, 2 November 2008, from Frankfurt Airport to the Maritim Hotel Würzburg at h and h. Travelling time approx. 2 hours On Wednesday, 5 November 2008, buses will transfer for Frankfurt Airport directly after the end of the conference. Travelling time: approx. 2 h. 2. By Train Alternatively, there is a direct 1h 30 min train connection from Frankfurt Airport to Würzburg Main Station. Organisation and Contact CONCEPT HEIDELBERG P.O. Box D Heidelberg Phone +49 (0) 62 21/ Fax +49 (0) 62 21/ info@concept-heidelberg.de For questions regarding content: Dr Günter Brendelberger (Operations Director) at / , or per at brendelberger@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Ms Marion Weidemaier (Organisation Manager) at / , or per at weidemaier@concept-heidelberg.de. 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. The official conference language will be English. Social Event On the evening of the first conference day, you are cordially 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.

8 # General Terms of Business Reservation Form (Please complete in full) Strategies against Counterfeit Medicines 3-5 November 2008, Würzburg, * Mr * Ms Title, first name, surname Company Department Important: Please indicate your company s VAT ID Number PO Number if applicable Street/P.O. Box City Zip Code Country Phone/Fax (please fill in) 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 registration 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? If the bill-to-address deviates from the specifications on the right, please fill out here: CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 62 21/ D Heidelberg GERMANY 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 Conferences 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