Competitive Advantages for Pharma Investing in Belgium

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1 Competitive Advantages for Pharma Investing in Belgium Creating Value in the Heart of Europe Thursday 21 November 2013 Location: CIPAL Cipalstraat, 2440 Geel A visit of the Genzyme Geel plant will be organised in the afternoon Table tops will be accessible during the seminar

2 8:00-9:00 Registration and Coffee 9:00-9:15 Welcome (Jef De Clercq) 9:15-9:40 Keynote Speech (Karel Tobback, Kabinetschef Socio-Economisch Beleid Kabinet Minister-President Kris Peeters) 9:40-10:10 Vaccines: A Belgium Manufacturing Competence (Marc Sohet, Vice President Head of GSK Vaccines Engineering and Business Operations Shared Services) 10:10-10:40 Our Road to the Pharma Plant of the Future; Beerse 2020 (Chris Van Offenwert, Sr Manager Janssens Pharmaceutica) (Toon Truyens, Director Technical Services Janssen Supply Chain) 10:40-11:10 Coffee Break with Table Top & Networking Opportunities 11:10-11:40 Pfizer Puurs Center for Secondary Packaging Expands While Optimizing Operations (Herwig Vossius, Project Leader, Pfizer) 11:40-12:10 Environmental Sample Reconciliation Using RfID Technology (Mikaël Couvreur, Pharmaceutical Workflow Engineer, Alcon) 12:10-14:00 Lunch with Table Top & Networking Opportunities 14:00-14:10 Welcome at Genzyme (Jo Dalle, VP and General Manager, Genzyme Geel) 14:10-14:30 Genzyme s Investment in Geel: Business Case (Martin Geukens, Director Technical Services, Genzyme) 14:30-15:00 Intro to the Stella Project: Scope, Technologies, Timelines, Partners... (Pierre Waterkeyn, Lead Engineer Stella Project, Genzyme) 15:00-17:00 Genzyme Plant Visit - Stella Project (Pierre Waterkeyn, Lead Engineer, Stella) 17:00-19:00 Q & A and Closing of the Day with Networking Reception 2

3 Presentations Vaccines: A Belgium Manufacturing Competence. (Marc Sohet) From 1945, RIT, SmithKline and nowadays GlaxoSmithKline develop vaccines knowledge and products in their Belgium facilities. The main levers of the Vaccines Business deployment in Belgium are linked to Innovation, favourable environment, people qualification. New manufacturing facilities have been erected in the last years on our sites; experience related to these investments will be presented. Our Road to the Pharma Plant of the Future: Beerse (Chris Van Offenwert, Toon Truyens) From the Pharmaceutical Operations World in the early nineties the Beerse Manufacturing Site has evolved to a high volume, cross sector enterprise plant for Pharma and Consumer products. The need to perform an in depth QCDISM (Quality, Cost, Delivery, Improvement, Safety, Morale) assessment, opportunities were highlighted resulting in our vision for the right to produce in the plant of the future; Beerse During this presentation the conducted process as well as innovative projects like decoupling, brite stock strategy, increased level of automation... will be explored. Pfizer Puurs Center for Secondary Packaging Expands while Optimizing Operations. (Herwig Vossius) The Center for Secondary Packaging of Pfizer Puurs packages in excess of 200 M sterile units per year. Recently several significant investments have been made to expand capacity. This was achieved partly by building extensions and partly by automating processes. The area for packaging operations was doubled by building a second packaging module. The warehouse capacity was increased by 50 (Ambient) to 100% (Cold Storage) by equipping the warehouse with automatic cranes. Cost improvements were generated by automating several of the warehouse operations, e.g. picking activities, transporting pallets to and from the Packaging area. Environmental Sample Reconciliation Using RfID Technology. (Mikaël Couvreur) This project was initiated to maximize tracking of cleanroom stays and cleanroom gowning samples. By introducing RfID technology overall effectiveness increased enormously. This technology is capable of detecting and identifying tags that are within range of an embedded floor antenna. By putting uniquely identified tags in cleanroom shoes, it s possible to track people s cleanroom stays. Secondly, the registration of samples was simplified by presenting the operator a personal sampling plan. By matching both movements and samples, it became possible to perform automatic reconciliation. Expansion of manufacturing capacities at Genzyme, Geel, Belgium (Martin Geukens) Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years, becoming one of the world's leading biotech companies. In October 2001, Genzyme Corporation acquired the Belgian part of Pharming N.V. in Geel, Belgium to develop Genzyme s first bio therapeutics manufacturing facility in Europe. In 2010, the construction of an additional, autonomous plant started to support long-term growth and new future products. During the presentations of the business case and scope of the expansion, the decision process, plant lay-out and project execution will be outlined. In addition, a plant visit is provided. 3

4 Who should attend? All stakeholders responsible for: and active in: Development and Technology Transfer Regulatory, validation, QA and GMP Manufacturing and Quality Control Technology and Engineering and Automation Pharmaceutical Biopharmaceutical Biologics API Related Life Science industries 4

5 REGISTRATION FORM SEMINAR 21 November 2013 Return LATEST before 14 November at PARTICIPANT: Last name: First name: Title: Company: Street: City: ZIP Code: Tel.: PARTICIPATION IN THE COST (INCLUDING LUNCH AND NETWORKING) I am ISPE member nr and I pay 275 for the participation I am not yet an ISPE member and I pay 495 for 1 year membership and participation * I paid on the ISPE BELGIUM bank account (with mention of Name & PO nr.) BE (Bic: GEBABEBB) OR Visa/Master card nr: Cardholder name: Amex card nr: Cardholder name: Expiry date: Expiry date: Date:... Signature:... ISPE reserves the right to delay the meeting and modify the program and the place, in case of force majeure. Confirmation of subscription will be sent one week before the seminar date together with a road map. Any cancellation received later than one week before the event will not be credited. * Preferred 5

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