Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health

Care Inspectorate, The Netherlands

 

Riekert Bruinink holds a MSc degree and Pharm D degree from the University of Utrecht, the Netherlands.From 1981 to 1987 he worked as pharmacist in several public pharmacies. In 1987 he joined the Drug Inspectorate and in 1995 the Health Care Inspectorate in the Netherlands.

Riekert Bruinink held various positions, including management positions. He is now a GMP/GDP Senior Inspector and specializing in Good Distribution Practice. He is chairman of the PIC/s GDP working group since 2007 and member of the EMA GDP drafting Group. This group is responsible for making a proposal for a new EU GDP Guide and procedures for harmonizing GDP inspections in the European Union.

CSS 2017 Speaking Panel

 

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Ulrike Kreysa, Vice President Healthcare, GS1 Global Office

 

Ulrike Kreysa is responsible for the Healthcare sector at the GS1 Global Office in Brussels and works with her local colleagues in 112 countries across the world to develop and implement GS1 standards in the healthcare industry. Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, group purchasing organizations, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations. Ulrike works regularly with decision makers from leading companies and regulatory bodies to drive harmonisation of standards in the implementation across the world. She is a regular speaker at global conferences.

 

Turhan Özen, Chief Cargo Officer, Turkish Airlines

 

Born in 1968, Turhan ÖZEN graduated from Galatasaray High School, then studied Business Administration in Boğaziçi University, and attended Koç University Executive MBA program.

Started his career in 1991 at IVECO, he worked on sales, marketing, and logistics management positions. After that, in 2000 he joined TNT Logistics during its foundation as Business Development Manager, and later took the position of Distribution Operations Group Manager and Operations Director. Continuing the same position at CEVA Logistics as of 2007, Özen became Deputy Managing Director – Commercial in 2011; after that between 2013 and 2015, he became CEVA Balkans-Middle East and Africa Region Business Development and Sales Vice President, and later CEVA Global Health Sector President. Turhan Özen, who had been CEVA Logistics Middle East and North Africa Region Managing Director since the beginning of 2016, took office at Turkish Airlines Corp. as Chief Cargo Officeras of December 2016.

Turhan Özen, is fluent in English and French, married, and father of two children.

 

 

Nathan Vaidyanathan, Finance Lead, Roche Pharmaceuticals

 

Nathan is an experienced Finance / IT leader with several years of executive experience in Pharmaceutical and Consulting companies, especially in Technical Operations and Supply Chain Finance

Robert Potts, Director, International Quality, Vertex Pharmaceuticals

 

 

An experienced director within the pharmaceutical industry, with experience of GMP, & GDP.  Through his time in industry Robert has spent time in R&D start-up company, a CMO, a large API manufacturing manufacturer, a global generics organisation and companies starting out on their commercial journeys.

 

Roberts has worked closely with supply chain in developing controlled temperature transit strategies & qualifications and numerous expansion activities, including setting up new entities through to out licencing and Distribution Partners.

Serge Van Houten, Manager Logistics, Plasma Industries

 

Education: Industrial Engineer

 

1998: Software Engineer Material Handling (Egemin)

2000: Project lead Materials Handling (Egemin)

2002: Equipment Engineer (Pfizer)

2009: Warehouse Supervisor (Pfizer)

2014: Logistic Manager PIBe

 

Murat Ates, Qualified Person, Medcor Pharmaceuticals

 

2012-2015: Pharmacist at Medsen pharmacy Roombeek and Medsen pharmacy Enschede Noord.

  • Ensuring service to customers and contribute to the objectives of the pharmacy.

May 2015-November 2015: Pharmacist at Mediq pharmacy Vroomshoop

  • Ensuring service to customers and contribute to the objectives of the pharmacy

November 2015-Heden: Qualified Person at Medcor Pharmaceuticals te Lelystad and RP at G-pharmaceuticals

  • Approve relabelled medicines for Dutch market

o Participate Management-team meetings

o Participate Quality and Registration meetings

o Performing internal/external audits

o Performing on different QA-system activities (validations, mapping, deviations change control, pharmacovigilance, complaints, recalls act).

o Approve SOP’s, QA, TA and SLA

 

Ahmet Ceylan, Qualified Person, Medcor Pharmaceuticals

 

QP/RP/Pharmacist at Medcor Pharmaceuticals B.V., Lelystad (2014- present)

Activities and Societies:

o Approve relabelled medicines for Dutch market

o Participate Management-team meetings

o Participate Quality and Registration meetings

o Performing internal/external audits

o Performing on different QA-system activities (validations, mapping, deviations change control, pharmacovigilance, complaints, recalls act).

o Approve SOP’s, QA, TA and SLA

 

• Pharmacist at Instellingsapotheek, Ede (2012 – 2014)

Jan Walbrecker, Senior Software Developer, SmartCAE

 

Dr. Jan Walbrecker received his Graduate Diploma in Science at Victoria University of Wellington, New Zealand, and his Diploma in  Geophysics at Ludwig-Maximilians-University Munich, Germany, studying  exploration techniques and thermal processes of Earth. He went on to complete his PhD in applied and environmental geophysics at ETH  Zurich, Switzerland, mainly concentrating on developing and improving magnetic resonance imaging techniques for groundwater exploration. As a postdoctoral researcher, he engaged in research projects at Stanford University, US, extending his research on geophysical processes involving multiscale numerical modeling and simulation. Today Jan is working as software developer at SmartCAE Stefan Braun in Munich, Germany,  developing and constantly improving software to simulate the thermal evolution of passive shipping systems used in food and pharma cold chain.

 

Jost Bunse, Logistics Consultant, Die Logistik Experten

 

Since 2015 Die Logistik Experten Unternehmensberatung GmbH

Logistics-Consultant (Partner)

2013 – 2015 Alliance Healthcare Deutschland AG: Deputy Managing Director of Subsidiary CPL

2008 – 2012 NextPharma GmbH: Managing Director Logistics

2007 – 2008 Miebach Consulting GmbH: Director of Market Segment Process industry

2004 – 2006 Rhenus AG & Co. KG: Key Account Manager Pharma Logistics

1997 – 2003 DHL / Deutsche Post AG: Key Account Manager

1991 – 1996 Phoenix Pharmahandel AG & Co

Gino Vleugels, Senior Manager Temperature Control, Johnson & Johnson

 

Gino Vleugels, studied chemical engineering at the University of Antwerp.

 

Gino Vleugels has been working in research and development of the Pharmaceutical industry for more than 8 years, where he was responsible for the global logistics of investigational medicinal products.

 

Current responsibilities are identifying and deploying optimal solutions that address the storage and distribution temperature needs of the EMEA region for all products of Johnson & Johnson including Pharma, Consumer and Medical Devices.

Francesca Burberi, TS/MS Senior Manager, Eli lilly

 

 

Calibration and Periodic Validations in the pharmaceutical environment.

 

• Validation state in the aseptic environment of the production manufacturing area.

 

• Cold Chain Management and the shipping studies of the site for the API product/ process.

 

• Validation of the Cold Chain of the new auto-injector Trulicity (lauch project) the packaging validation of the new packaging line R2 (2015- 16 years project).

Reinhard E. Voglmaier, Computerised Systems Manager, GlaxoSmithKline

 

Reinhard Voglmaier, graduated in Physics at Technische Universität München, is IT Systems Validation Manager in the Medical Department in GlaxoSmithKline Italy. He has the CISA certification from ISACA and is leading the ISACA GxP expert charter in Germany. Before this he was senior project manager for European IT Projects at GlaxoSmithKline.

He coordinated also the SarbOx testing of the European IT Infrastructures and of the European Technical Centre of GlaxoSmithKline and has experience as IT Internal Auditor in GSK Italy. He presented at several conferences for IT Governance and Computer System Validation and gives guest lectures on IT Governance at Rzeszów School of Business in Poland.

Jackie Peck, Managing Director, Pharmacy Consulting Limited

 

Owner of Pharmacy Consulting Limited, she purchased the company in July 2012 and has successfully expanded the business from a “One Man Band” to sixteen team members. Pharmacy Consulting is committed to quality, patient care and both their and their customer’s compliance. The company has expanded their services to include GDP training, audit, Quality System Builds.

Stefanie De Ghey, Quality Manager Benelux & Qualified Person Benelux at Movianto Belgium NV and O&M –Movianto Nederland B.V.

 

Stefanie De Ghey, Quality Manager/Qualified Person/Responsible Pharmacist at Movianto Belgium has been responsible for quality assurance in several leading roles at various leading pharmaceutical companies. Throughout her career she has been responsible for product

releases, complaint handling, change control handling and compliance. As QM/QP/RP she holds the overall responsibility for the temperature controlled logistics and value added services, provided by Movianto Belgium.

 

Mark Edwards, Managing Director, Modalis

 

Mark has over 25 years of logistics experience garnered at a variety of logistics service providers and product manufacturers; he is currently the Managing Director of Modalis which is a dynamic logistics consultancy specialising in pharmaceutical and temperature-controlled logistics.

 

His projects at Modalis have included helping a major pharmaceutical manufacturer to achieve GDP compliance, moving an electronics manufacturer to a new freight provider to save 40% on freight costs, migrating 2 distribution centres for a telecommunications company and successfully assisting various companies with their RFP/RFQ.

Eveline van Schie – van Waaij, Qualified Person, Amstelfarma

 

Working as Qualified Person at Amstelfarma for 6 years

 

- worked in the past for R&D in a different company

 

- studied Biopharmaceutical sciensces, Leiden, NL

Sven Sachsse, Transport Expert - Supplier Qualification, Bayer Pharma

 

Education:

 

Sept. 2011 - Jan. 2015, Industrial Engineering (B.Sc)

University of Applied Sciences  Moenchengladbach / Krefeld

Working Experience:

Dec. 2015 - Now, Transport Expert - Supplier Qualification, Bayer Pharma AG

Sept. 2014 - Dec. 2015: Trainee Transportation Management, Bayer Pharma AG

Sept. 2013 - June 2014, Assistant Merchandise Processes, Fressnapf Tiernahrnungs GmbH

Olivier Simonnot, Senior Manager Strategic Marketing, Life Sciences EMEA, Sensitech

 

Olivier Simonnot has been working for Sensitech Inc., UTC Climate Controls & Security, a unit of United Technologies Corp., for nine years and currently holds the position of Senior Manager Strategic Marketing, Life Sciences EMEA. He previously held several positions in Marketing and Product Management in several international technology oriented companies. He holds a Master of Science in Telecommunications from the French engineering school ESIGETEL and a Master in Business Administration from the Rotterdam School of Management. He is an active member of the French Cold Chain Association, participated in the sub-commission on Metrology and Risk Assessment, Last Mile and is currently active in the EU GDP working group.

Frank Peeters, Managing Director, Tobeas

 

Frank Peeters studied pharmacy, graduated as industrial pharmacist and obtained a Ph.D. in pharmacology at the University of Antwerp. In 2002, he started his own consultancy company Tobeas bvba, focussed on GMP, GDP and medical devices with special interest in computerised

systems and pharmaceutical distribution. He has also been teaching Corporate Quality Management at the University of Antwerp and since 2010 he is appointed guest professor at the University of Leuven, giving courses on Biotechnology and Recent Advances in Science and Technology. As LtKol in the reserve he is also active in the medical component of Belgian defense.

Rob Dekkers, Global Logistics Manager SPECT/PET and Dangerous Goods Compliance, GE Healthcare

 

Rob Dekkers, MSc (born 1960 in the Netherlands)His current role is Global Logistics and Distribution Leader, Working for GE Healthcare, Core Imaging, located at Eindhoven, NL, In his role he is responsible for the global distribution of the GE Healthcare radiopharmaceuticals and contrast media. He is the Chairman of the AIPES Transport Working Group. Rob graduated from the Eindhoven University of Technology; He received his Master of Science degree in 1988 from the faculty “Technology and Society”.

Jeroen Janssens, Sr. Manager Vaccine Distribution & Cold Chain, GSK Vaccines

 

Jeroen Janssens, Sr. Manager Cold Chain and Distribution at GlaxoSmithKline Vaccines has 15 years of experience in the pharmaceutical industry. He started his career in the quality assurance department with responsibilities for warehousing, distribution and cold chain for several pharmaceutical companies. After 9 years in QA, he spent 2 years at the Engineering department for Cold Chain within GSK Vaccines before moving to his current position. As a cold chain Engineer, he was responsible for the development and qualification of cold chain active and passive packaging. In his current role, he is a Subject Matter Expert for cold chain supporting and guiding the global network of manufacturing and distribution sites with his technical expertise.

Gabriel Bolland, Supply Chain Manager, ANMI

 

Gabriel owns a Bachelor degree in Biotechnology and Biochemistry. He has also a strong experience in logistics and supply chain in the radiochemical field.

Chris Wallace, International Supply Chain Director, Global Commercial Supply Chain,  Genzyme

 

Chris Wallace is International Supply Chain Director for Genzyme in the EMEA region. He is responsible for logistics development and operations, distribution compliance including third parties, new product introductions and the establishment of new routes to market. He has nearly 30 years supply chain and logistics experience across multiple sectors but believes some of the most exciting supply chain developments are at present in the Pharmaceutical and Healthcare sector.

Chris holds a degree in Economics from Manchester University, a MBA from Aston University Business School and a post-graduate Diploma from London University.

Katia Toebosch, QA Specialist, Volcano Philips

 

• Bachelor degree in pediatric nursing.

• 7 years responsible in a medical shop selling all kind of medical devices.

• 4 years of experience working for the Belgium Trade Association of medical devices.

• 4 years of experience as QA/Compliance manager medical devices EMMEA (Cyberonics)

• 5+years of experience as QA Specialist International Philips Volcano in Brussel’s Distribution Center

• Certified auditor ISO 13485:2003

• Regulatory Affairs Certificate Medical Devices – RAPS – May 2013

• Within Philips Volcano responsible for QMS, complaint handling, vigilance reports, FSCA, internal auditor, CAPA specialist.

 

Isabela Furtado, Supply Chain Manager EMEA, Terumo BTC

 

Working for Terumo BCT since 2009 and Supply Chain Manager EMEA since 2015

Worked before in Supply Chain for Arcelor Mittal and AB InBev

 

 

Olivia Yalung, Supply Chain Business Partner, Terumo BTC

 

Working For Terumo BCT since 2011. Worked before with DHL Express and DHL Global Forwarding

 

 

Bart Pouwels, Business Development Director, Amsterdam Airport Schiphol

 

Bart joined Amsterdam Airport Schiphol’s Cargo Department in early 2008. His responsibilities include working with carriers to develop Schiphol’s network of destinations and frequency of services, in order to increase its appeal as a gateway for cargo into Europe.

He is also tasked with protecting Schiphol’s position among Europe’s major cargo gateways. Schiphol has successfully held third place among Europe’s cargo airports for some years, despite the smaller size of its domestic market. Its traffic levels have meanwhile performed much more strongly than either of its two main rivals. Bart’s work involves close cooperation with IATA, The Dutch and European Shippers Councils, and the Dutch Government in Holland and overseas. He leads frequent overseas missions, often working alongside ministers, ambassadors and the Mayor of Amsterdam. He also hosts high-ranking foreign delegations visiting Schiphol.

 

 

 

 

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An event by Pharma Dialogue, the Healthcare division of