Speakers

Cool Chain Europe and Cool Clinical Logistics 2010 Speakers

• Rafik H. Bishara, Ph.D, Technical Advisor, PCCIG Chairperson PDA
• David A. Ulrich, QA Distribution Director, Global Pharmaceutical Operations (GPO), Strategic Quality Initiatives (SQI), Abbott
• Gert-Jan van Diest, QA Specialist Cold Chain Management, Abbott Laboratories
• Ian Holloway, Manager, Defective Medicines Reporting Centre, MHRA
• Ingo Ocklenburg, Global Sourcing Manager, Distribution Logistics, Bayer Healthcare
• Jim Bacon, Director, Global Demand Planning & Customer Operations, Talecris Biotherapeutics Inc.
• Joachim Kuhn, Physicist CEO and Co-Founder, va-Q-tec AG
• Mr. Riekert Bruinink, Chairman of the PIC/S GDP Working Group, Member of the EMEA GDP Drafting Group, Dutch Health Care Inspectorate
• Dr. Johann Kurz, Deputy Head Pharmaceuticals and Medical Devices, Federal Ministry of Health, Austria
• Umit Kartoglu, Technical Officer and Scientist, World Health Organisation
• Vildan Kortan, Director, WW Clinical Supply Logistics, Bristol-Myers Squibb
• Dr. Herbert Ernst, Life Sciences Program Manager, Sensitech
• Matthew McMenamin, Validation Manager, GMS Biopharmaceuticals, GlaxoSmithKline
• Karin Baer, Vice President, Quality, Omrix Biopharmaceuticals
• Stephen Moss, Quality Manager, Logistics, GlaxoSmithKline
• Søren Kåre Nielsen, Quality & Projects, Shipping & Customer Service, Novo Nordisk A/S
• Morten Duus Eriksen, International Freight Manager, Novo Nordisk A/S
• Jose Paguillo, European Logistics Process Manager, Pfizer
• Patrick Esselaar, Managing Director, Movianto Belgium
• Kevin O'Donnell, Director & Chief Technical Officer, Thermosafe & Chair, IATA Time & Temperature Task Force
• Erik Van Asselt, Cold Chain Improvement Manager, Vaccines, Merck Sharp & Dohme BV
• Shirley Feld, Deputy Director, Corporate Supply Chain Quality & Compliance, Sanofi-Aventis
• Claude Ammann, Site Manager & Director QA/QC, TopoTarget
• Csilla Wolf Farkas, Manager, International Clinical Logistics, Biogen
• Rinus Govers, Manager Material Handling, Crucell Holland B.V
• Stanislav Pavlin, Ph.D., Faculty of Transportation & Traffic Sciences, University of Zagreb
• Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm Solutions & Chair, Midwest Clinical Supplies Group, Inc.
• Susan Elgaard Hansen, Clinical Supply Coordinator, Clinical Pharmacology Supply, Lundbeck
• Vildan Kortan, Director, WW Clinical Supply Logistics, Bristol-Myers Squibb
• Bernadette D.M. Cunningham, Director, Pharmaceutical Operations, OSI Pharmaceuticals, Inc

Rafik H. Bishara
Ph.D, Technical Advisor
PCCIG Chairperson PDA

Rafik H. Bishara, Ph.D., is the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA). Dr. Bishara has served as a Temporary Adviser to the World Health Organisation (WHO) since July, 2007.

Dr. Bishara retired from his position as Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company after a 35-year career. During his tenure at Eli Lilly and Company, Dr. Bishara was responsible for the Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration.

Dr. Bishara frequently chairs and presents at industry leading conferences, has authored numerous articles, and technically advised several organisations on Good Cold Chain and Temperature Controlled Management Practices. Dr. Bishara received his Ph.D. from Purdue University, Indiana, USA.

Dave Ulrich
GPO QA Distribution Manager
Abbott

Currently, Dave is the QA mgr for Distribution and Logistics for Abbott's GPO division. His responsibilities include standardization & optimization of quality systems (cGDPs), cold chain management and import export compliance activities (FDA, USDA and EPA). He has been at Abbott 20 years, with the majority of time spent in bulk (API) manufacturing operations, manufacturing QA and plant maintenance & engineering.

Gert-Jan van Diest
QA Specialist Cold Chain Management
Abbott

Management project. In this short period he became subject matter expert on temperature controlled supply chain in Pharma.

With a former position within one of the largest food companies in The Netherlands, responsible for planning and transport, Gert-Jan brings a lot of cold chain experience in the project.

In his role Gert-Jan lead the migration project team in Abbott's brand new warehouse in Breda, The Netherlands, and implemented new solutions for large volume international shipments.

Gert-Jan hold's a degree in Business Economics and Logistics at the HES Amsterdam.

Ian Holloway
Manager, Defective Medicines Reporting Centre
MHRA

Mr Ian Holloway is manager of the UK Defective Medicines Report Centre for the MHRA (UK Regulatory Agency) located in London. The centre liaises with manufacturers, distributors, hospitals and pharmacies to direct recalls, issue timely notifications and oversee corrective actions for confirmed and suspected medicine defects.

He is a registered Pharmacist and has post-graduate qualifications in Pharmacology and Business Studies. He previously worked for the MHRA for over ten years as a site inspector for Good Manufacturing Practice and Good Distribution Practice at sites in the UK and worldwide. Prior to joining the Defect Centre he worked for the Agency as a Pharmacovigilance inspector and helped establish a new system of site Pharmacovigilance inspection systems.

Ingo Ocklenburg
Global Sourcing Manager, Distribution Logistics
Bayer Healthcare

He joined Bayer in 1997 for the function of Logistic Procurement Airfreight and Express Services. Ingo is a logistic expert and has a broad experience within the Aircargo Industry for more than 25 years. In his previous functions he worked for Airfreight Forwarding Agents, for a Canadian Airline and for an Aircargo Broker Company in various management positions for marketing and sales.

In his function as a Global Sourcing Manager Distribution & Logistics, he is responsible for all global logistics spends of Bayer HealthCare for Airfreight and Express Services. In addition, he is also Lead Buyer for the Procurement Synergy Areas Airfreight and Express Services for the Bayer Group globally.

Jim Bacon
Director, Global Demand Planning & Customer Operations
Talecris Biotherapeutics Inc.

Jim Bacon is Director, Global Demand Planning & Customer Operations at Talecris Biotherapeutics, Inc., at their head office in Research Triangle Park, North Carolina. In his role, Jim has responsibility for global Sales & Operations Demand Management, international customer service and logistics, and is a subject matter expert on cold chain logistics.

In 2006, Jim was responsible for establishing logistics services for Talecris with 3PL's in Canada and Germany, as Talecris expanded its business worldwide.

Jim has led the cold chain team effort at Talecris/Bayer, since 2002, implementing solutions to improve safety and integrity of product from domestic small package to multi pallet international shipping. Jim has been published in various industry publications featuring Talecris’ advances in cold chain management and describing the process and relationships required to develop sound solutions.

Joachim Kuhn
Physicist CEO and Co-Founder
va-Q-tec AG

Dr. Joachim Kuhn: born May 02, 1964 in Miltenberg / Germany, Physicist, is the co-founder and now CEO of va-Q-tec AG. He has been working since 1989 in thermal physics, graduating in 1990 in "physics of conventional insulation material", with a PHD on "thermal radiative transport in heat insulation".

He is a material scientist initiating several innovations for conventional insulation materials which have now become common practise in industry and working on temperature controlled packaging since 2001. His hobbies include sports, in particular table tennis with some responsibilities in German and International Table Tennis Federation.