4TH LOGIDAYS 2018 END TO END PHARMACEUTICAL/BIOPHARMACEUTICAL GDP LOGISTICS:
SPEAKERS & CONTRIBUTORS
Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health Agency
Riekert Bruinink is working at the Dutch Healthcare Inspectorate and held various positions, including management positions. Now he is a Senior GMP/ GDP Inspector and specialized in Good Distribution Practice. He is Member of the EMA GDP Drafting Group . This group was responsible for making a proposal for a new EU GDP Guide and procedures for harmonizing GDP inspections in the European Union. From 2008 until 2013 he was Chairman of the Pharmaceutical Inspection Co-operation Scheme(PIC/S), a worldwide organization of pharmaceutical inspectorates of different countries.
Maurizio Caschera, Quality Responsible Person, MSD
Maurizio Caschera is one of two Quality Responsible Person for MSD Italy with a specific responsibility for Vaccines.
He began his professional life in Janssen Cilag in the Manufacturing Plant of Latina.
Later, until 2016 he worked for Sanofi Pasteur MSD as Quality Assurance Manager gaining experience for Cold Chain and ISO 9001 requirements.
Kenny Onasanya MCIPS, Procurment Supply Chain, I+Solutions
Kenny Onasanya MCIPS is a pharmacist and procurement and supply chain management expert with over 15 years diversified experience covering pharmaceutical supply chain mapping and assessments, system design, supply chain capacity building, project management, procurement and supply chain management. At i+ solutions, he is a Procurement and supply chain Subject Matter Expert, in-country supply chain improvements and system strengthening team focusing on diagnostics, capacity building and project implementation in pharma logistics in Africa. He also coordinates I+Solutions training portfolio, curriculum development and e-learning. He is a certified member of the Chartered Institute of Logistics and Transport (CILT UK), Supply Chain Management Professional (SCMP, Canada) and Chartered Institute of Purchasing and Supply (CIPS UK). He graduated from Robert Gordon University, Aberdeen, UK (2012)
with an MSc Purchasing and Supply Chain Management (with Distinction) and Bachelor of Pharmacy from Obafemi Awolowo University, Ile Ife, Nigeria. Overall, he has over 17 years’ experience managing essential medicines and other health commodities with public sector, private sector, NGOs in Africa.
Francesca Burberi, Tsms Sr Manager, Eli Lilly
Eli Lilly Italia Responsible for Calibration and Periodic Validations.
Francesca has a bachelor degree in Chemical & Pharmaceutical Technology; she works in the pharmaceutical environment since 1991, with different assignments in manufacturing.
Francesca is responsible for the validation state in the aseptic environment of the production manufacturing area. She has the responsibility of the sterilization systems and the equipment qualification of the manufacturing plant in Sesto Fiorentino, Italy.
She is responsible of the Change Control System in the site. She has responsibilities for the Cold Chain Management and the shipping studies of the site for API product/ processes.
She is responsible of the validation of the Cold Chain of the API, pharmaceutical products taking care of their logistic aspects.
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.
Amer Alghabban, GxP Consultant & Trainer at GXP COMPLIANCE, Karyopharm Therapeutics
Amer has over 26 years of experience in the pharmaceutical industry. Prior to joining Karyopharm, he was the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies and aca¬demic institutions to achieve compliance with GCP, GVP and GLP. Prior to that, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono.
Mr. Alghabban has published 2 references books, Pharmaceutical Medicine Dictionary and Dictionary of Pharmacovigilance. He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA.
Matti Lähde, Vice President Production, FIT BIOTECH
Matti has been the Chief Production Officer, FIT Biotech since 2015.
Long experience in research, process development and biological production. Before joining FIT Matti has worked at Ark Therapeutics Oy and Biofile Ltd, and has experience in managing the manufacturing of Gene Therapy Products in a cGMP environment. He also has experience in cancer research at Orion and virology research at Turku University. Matti Lähde holds a Master of Science in Biochemistry and Molecular Biology.
Julia Mauger, Clinical Supply Manager Clinical Development Unit, Nestle
Senior Specialist in Clinical supply management in Nutritional Clinical Research with 10 years of experience. Analytical, process oriented but also energetic and network focused with strong background in Quality Management and R&D Nutrition.
Petra Zartner, Senior Manager QA/QC, Immunomedics
Departmental Work Experience:
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.
Neal A. Gordon, PhD, Director, MRL Logistics Global Clinical Supply, Merck & Co, Inc
Neal Gordon holds a Ph.D. in pharmacy from the University Of Michigan College Of Pharmacy and has over 30 years’ experience in the pharmaceutical industry. He has developed an expertise which includes scale-up and tech transfer, validation and packaging and clinical supplies planning project management pertaining to new drug product development. Neal has also lead numerous CMC PAI teams and interfaced with FDA officials both in Washington DC and San Juan Puerto Rico. His strengths are in finding solutions to problems, coaching and developing others, being a bridger, cross functional teamwork and collaboration, seeing and understanding the entire drug product development process. Neal is presently director of Logistics and Trade Operations for Merck Research Laboratories, responsible for US Distribution Operations and Planning, as well as Import and Export Trade Operations organizing in support of activities in line with global portfolio strategy.
Mr. Matthew Z Olkowski, Senior Specialist, Trade Operations, Global Clinical Supply, Merck & Co, Inc
Matthew Olkowski is a Senior Specialist of Trade Operation for MRL Logistics at Merck & Co with a focus on international exports. Matt began his career at Merck in 2007 as an Import and Receiving Specialist. In 2009, he accepted a role in the MRL Logistics – Order Fulfillment & Exports group processing domestic and international shipping requests. He supported the transition from ad-hoc export filings to the use of the GTAS trade management system for clinical and research shipments. He also led transition from paper-based shipping requests to the use of the SWMS database. In 2016 he was appointed as the Team Lead of the MRL Logistics and Order Fulfillment & Export group and has become the area SME for the related SAP transactions for both Material Handler and Trade Operation roles.
Petar Simic, CEO, Primaco Pharma Logistics
Petar Simic: Senior Executive with demonstrated history in transportation, IT & pharmaceuticals industry. Broad experience in business process optimization, setting up companies strategy and business model turnarounds. Master in Business and Economics educated in Zagreb and London
Boris Vavra, Director of Pharma Division, Primaco Pharma Logistics
Boris Vavra: Strong customer service and business development professional with a demonstrated experience in pharmaceutical industry. Licenced IATA cargo agent, Master in Transportation Engineering, skilled in Supply Chain Optimization, Logistics, Warehouse Management Systems, and Freight Forwarding.
Thomas Thoma, Head Clinical Trial Supply, Teva Group
Bachelor and Diploma of BA from the University of Augsburg, Germany
3 years Forecasting and Demand in the IT Industry at Siemens
5 years Supply Chain Management in the automotive industry at Alpine Electronics
6 years Supply Chain Manger awarded to Head Operative Supply Chain at Teva / Mepha Switzerland, member of the Teva Group
Responsible for Generics and Specialties
3 years Head Clinical Trial Supply (Sales) Europe
Valentina Marinkovic, Associate professor/ GxP Consultant & Coach, University of Belgrade
Valentina Marinkovic studied pharmacy and obtained a Ph.D. in pharmaceutical chemistry at the University of Belgrade. She has over 20 years of experience in multinational pharmaceutical companies (Actavis, Alvogen), fulfilling a position of the Quality director and QP. From 2015, as a associate professor at University of Belgrade, she is the director of postgraduate study program - "Pharmaceutical Management and Marketing“ and she is involved in many subjects related to Quality Management and Pharmaceutical Legislation. Also, Valentina works as a consultant and coach in area of GMP, GDP and GVP. Currently, she is guest researcher at RWTH University of Aachen, Germany.
Tania Snioch, Director Healthcare, GS1
Tania Snioch is Director Healthcare at GS1 Global Office. Tania supports the healthcare user community and GS1 local Member Organisations with the aim to enhance the level of GS1 System adoption.
Prior to starting at GS1, Tania worked for the Australian GS1 organisation, GS1 Australia. Tania and her team assisted the Australian Healthcare industry to implement the GS1 System; having the dual aims of helping to improve patient safety and supply chain efficiency. Tania has participated in a range of government initiatives working with both Australian state and territory governments and federal regulators.
Tania has an Honors degree in Biomedical Science from Monash University.
Jackie Peck , Director, Pharmacy Consulting Limited
Jackie Peck is a qualified Pharmacist and Responsible Person she has worked in the Pharmaceutical Industry for more than twenty years. Jackie is the owner of Pharmacy Consulting limited (PCL) which is a consultancy offering bespoke services for Wholesalers, Pharmacies and medical Clinics. PCL has a large client base across the EEA and more recently has expanded into America, Canada, Asia and Dubai. The client range from small start- ups to Big Pharma.
Sylvain Alberola, Head of Industrial Clinical Supply Chain, Sanofi
With a background of Engineer in advanced automation I spent 15 years in IT field.
From Developer to Senior Software Engineer in various businesses I started to work specifically for Clinical Supply Chain as Global Solution Center Head and then Clinical Supply Chain IT Business partner.
I am now in charge of Sanofi’s global Clinical Supply Chain Industrial Development.
Mattie Coolen Head Clinical Supply Operations, F. Hoffmann-La Roche AG
Thierry Gillard, Senior Clinical Supply Manager, Santhera Pharmaceuticals
After graduating in business management, Thierry Gillard has been involved in logistics and supply management for over 20 years.
He made his first step in clinical packaging and distribution in 2007 with a major CMO involved worldwide in clinical supplies management.
During 10 years with this CMO, he has been contributing to the set-up of a wide array of clinical studies and packaging designs from phase I manually distributed studies, to large Phase III IRT controlled studies, including supplies forecasting and Campaigns management.
Later on, in charge of Clinical supplies for Santhera Pharmaceuticals in Switzerland, the qualification of vendors and the definition of the IRT specifications for IMP supplies management falls under his responsibility.