EUROPEAN CONFERENCE

Efficient Supply Chain and Cold Chain Management Learn how to face globalisation and new regulatory challenges 14-15 October 2008, Prague, Czech Republic SPEAKERS:

HIGHLIGHTS:

From Authorities: Ian Holloway MHRA, UK Barry Rothman FDA, USA John Taylor MHRA, UK

 European and other Regulatory Requirements – EU, FDA, USP and WHO – PDA’s Medical Cold Chain Guideline – Harmonisation Efforts – Anti Counterfeiting Strategies

From Industry: John Davies GlaxoSmithKline, UK Kai Gindner Ernst & Young Global Pharmaceutical Center, Switzerland Oliver Gross ZLB Plasma, Germany Peter Kralinger CARRYMED Pharma & Transport GmbH, Austria Philipp A. Titulski Transo-Pharm Handels-GmbH, Germany Oswald Werle Inet-logistics GmbH, Austria

 How to Increase Efficiency – Business Models – Operational Excellence – Information Management – Logistic Process Design  Supply and Cold Chain Management – Risk Analysis – 15°–20° C Storage and Transportation – How to Qualify Transportation Activities  Special Topic – Particularities and Validation Issues with Human Plasma – RFID in Blood Transfusion Medicine

Efficient Supply Chain and Cold Chain Management 14-15 October 2008, Prague, Czech Republic

Objectives

Programme

During this conference, representatives from authorities as well as specialists from the pharmaceutical industry and service providers share their expert knowledge about all relevant aspects regarding the current expectations and the actual development in Supply Chain and Cold Chain Management. You will learn how these requirements evolve and how you can improve your systems.

A small World – A big Challenge  Globalization in the pharmaceutical Supply Chain  Global Communication for local Understanding  Global Business in conflict with local regulatory Requirements  Cross-border Trade inside and outside the EU Philipp A. Titulski, Transo-Pharm Handels-GmbH

Background Globalisation, counterfeiting problems and the expectations regarding the pharmaceutical supply chain and cold chain management are forcing the pharmaceutical industry to challenge their current practices. Companies have to increase their effort and validation activities as one prerequisite for safe and secure transportation of their medical products over boarders and through various climatic conditions. Guides, Guidelines and initiatives from various agencies and organisations like FDA, WHO, USP and PDA lead the way in this development and define expectations and requirements. But besides regulatory compliance there is another important aspect: logistic efficiency! The world is getting smaller and faster and various goods have to be delivered worldwide in given timeframes. The co-operation in the global value chain is characterised by high complexity and the need for co-ordination and control. The pharmaceutical industry needs to face these developments and align their strategies and business processes in the supply chain.

Efforts to control drug temperature in transit  FDA Initiatives  Expectations of the Agency  Additional regulatory steps needed Barry Rothman, CDER, FDA European and other Regulatory Requirements and Guidance  EU, FDA, USP, Canada, WHO, PDA  Who is responsible for maintaining product quality in the Supply Chain  Responsible Person and Qualified Person  Key challenges and criteria to consider  Distribution of blood products and tissues John Taylor, MHRA Increased Efficiency in the Pharmaceutical Supply Chain  Transformation towards Customer-oriented Pharma Network Business Models  Operational Excellence through an integrated Sales & Operation Planning  Strategic Value Chain Partnerships Kai Gindner, Ernst & Young

Target Group This conference is designed for all specialists, managers and executives who are involved in pharmaceutical supply chain activities at their company and who want to improve the existing processes. It is addressed to persons from Quality Assurance and Control, Logistics, Business Development, Manufacturing, Project Management and R&D.

Efficient and transparent design of the logistics process  Information Management over the whole Supply Chain  Track & Trace  SOX-Compliance  Integration of various logistic aspects Oswald Werle, inet-logistics Counterfeits - Analytical aspects and supply chain improvements  Activities of the MHRA  Counterfeit investigation and suspect analysis  Possible solutions and strategies  Flow of information and data Ian Holloway, MHRA

Risk Analysis in Supply and Cold Chain Management  Supply Chain Process & Risk Management  Risk Assessment Techniques in the Supply Chain John Davies, GlaxoSmithKline 15-25°C Storage and Transportation  Adequate storage facilities  Possibilities of transport  Monitoring, validation or nothing?  Requirements for transportation in or via Austria Peter Kralinger, CARRYMED Pharma & Transport GmbH Land, Sea and Air freight: particularities and validation issues with Human Plasma  Validation vs. monitoring  How to record temperature  Qualification of various transport routes  Data collection and evaluation Oliver Gross, ZLB Plasma Distribution Practice and Cold Chain Management in the Scope of Inspections  Why Good Distribution Practice?  Basic requirements  Compliance issues  Examples of serious GDP deficiencies John Taylor, MHRA RFID: Use in Blood Transfusion Medicine  What are we trying to achieve?  Technology  Enhanced Patient Safety  e-GDP  Process improvements  Pros and Cons John Davies, GlaxoSmithKline Case Study: How to qualify a Company’s worldwide Transportation Activities  Evaluation and set up the project  Challenges and pitfalls  How to deal with unfavourable conditions  Completion, conclusion and benefits Peter Kralinger, CARRYMED Pharma & Transport GmbH

Speakers John Davies GlaxoSmithKline, UK Before working for GSK, John Davies was IT-Quality Manager at the Austrian Red Cross, Vienna, Blood Donation Services, responsible for the implementation of GMP-compliant Quality Systems for IT-Systems and their validation. He started his career in the health industry at Baxter, where he held various managing positions in the IT and Quality area. Kai Gindner Ernst & Young Global Pharmaceutical Center, Basel, Switzerland Kai Gindner is Senior Manager of Business Advisory Services at Ernst & Young Ltd., Basel in Switzerland. He is leading the Supply Chain Management Group and is member of the Global Pharmaceutical Center in Switzerland. He is mainly concentrating on Performance Improvement activities. His experience embraces Project and Program Management, Supply Chain Management, Finance & Controlling, Benefit Monitoring as well as Compliance, Quality and Risk Management. Oliver Gross ZLB Plasma, Germany Oliver Groß studied biotechnology and works since 1997 for ZLB Plasma Services GmbH (former Centeon, Aventis Behring) integrated within the Australian based CSL Limited Group. Since 2005 is the responsible Quality Assurance & Validation Manager for the biggest European (Human) Plasma Logistic Center for production and IT systems. Beside other topics his main focus is the validation of all utilized transport methods. Ian Holloway Medicines & Healthcare Products Regulatory Agency (MHRA), UK Ian Holloway is the Head of the Defective Medicines Report Centre at MHRA. Peter Kralinger CARRYMED Pharma & Transport GmbH, Austria Peter Kralinger is the Managing Director of CARRYMED Pharma & Transport GmbH, the first GMP-licensed company providing international transport of temperature sensitive pharmaceuticals. Previously, as Director Logistics with Baxter, he was in charge of global transportation of all BioScience products in and outbound Europe. He has more than 25 years experience in Engineering and Project Management and spent 17 years within the pharmaceutical industry. He was one of the founding members of the Pharma Logistics Forum, a platform for experts from the pharma industry striving for best practices in transportation. Barry Rothman FDA, USA CDER, Division of Manufacturing and Product Quality, USA

John Taylor Medicines & Healthcare Products Regulatory Agency (MHRA), UK John Taylor is Quality and Standards Manager Acting and Group Manager, Enforcement and Intelligence of the UK Medicines and Healthcare Products Regulatory Agency (formerly the Medicines Control Agency). John Taylor is currently responsible for all quality matters within the Inspection and Enforcement Division. He is a Chartered Chemist, a Fellow of the Royal Society of Chemistry and a member of the British Institute of Regulatory Affairs Philipp A. Titulski Transo-Pharm Handels-GmbH, Germany Philipp Titulski is the founder and Managing Director of TransoPharm, a company dealing in API’s on a global basis since 1987 and having several offices worldwide. Starting his career in foreign exchange he has previously been employed with a pharmaceutical trading company. He is the president of the German Association of companies engaged in the wholesale and foreign trade in drugs and chemicals. Oswald Werle Inet-logistics GmbH, Austria Oswald Werle studied at the University of St. Gallen (Switzerland) and UC Berkeley (USA). For many years he was CIO of Gebrüder Weiss, a leading logistics service provider based in Austria. He was also working as a business consultant in different industries. Since 1999 Oswald Werle is founder, partner and CEO of inet-logistics, a leading supplier of standard software and professional services for Supply Chain Execution.

Social Event

At the end of the first day of the course you are invited to take part in an evening programme in Prague This is an excellent opportunity to share your experiences with the speakers and colleagues from other companies in a relaxed atmosphere.

Date

Registration

Tuesday, 14 October 2008, 09.00 – 17.30 h (Registration and coffee 08.30 h – 09.00 h) Wednesday, 15 October 2008, 08.30 – 15.30 h

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org. Conference language

Venue The official conference language will be English. Dorint Hotel Don Giovanni Vinohradská 157A 130 20 Prague 3, Czech Republic Phone +420 2 6703 1111 Fax +420 2 6703 6717 Fees Non-ECA Members € 1,790,- per delegate plus VAT ECA Members € 1,610,- per delegate plus VAT APIC Members: € 1,700.- per delegate + VAT (does not include ECA membership) EU GMP Inspectorates € 895,- 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. Accommodation CONCEPT has reserved a limited number of rooms in the conference 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 “VA 5535 ECA Event” to receive the specially negotiated rate for the duration of your stay. Reservations should be made directly with the hotel not later than 16 September 2008. Early reservation is recommended.

Organisation and Contact CONCEPT HEIDELBERG P.O. Box 10 17 64 D-69007 Heidelberg, Germany Phone +49 (0) 62 21/84 44-0 Fax +49 (0) 62 21/84 44 34 E-mail: [email protected] www.concept-heidelberg.de For questions regarding content: Mr Wolfgang Schmitt (Operations Director) at +49-62 21/84 44 39, or per e-mail at [email protected]. For questions regarding reservation, hotel, organisation etc.: Ms Marion Grimm (Organisation Manager) at +49-62 21/84 44 18, 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 What Is ECA? 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 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 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)!

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 Software 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 a 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. 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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CONCEPT HEIDELBERG P.O. Box 101764 Fax +49 (0) 62 21/84 44 34

D-69007 Heidelberg GERMANY





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Efficient Supply Chain and Cold Chain Management 14-15 October 2008, Prague, Czech Republic

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