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.

Florian Siedenburg, CEO, Ecocool

 

Diploma in Economics and doctoral degree in Econometrics

 

2010-2013 working as consultant in a data analysis company

 

Since 2013 working for ECOCOOL. Focus on development of cost effective thermal packaging solutions for the pharmaceutical industry.

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.

Tania Snioch, Director Healthcare, GS1

 

Tania Snioch is Director Healthcare at GS1 Global Office. Tania joined GS1 at the start of October 2014, when she moved from Melbourne, Australia to Brussels.  In her role at GS1 Global Office, Tania supports the GS1 user community by pro-actively responding to specific business requirements from industry sectors with the aim to enhance the level of GS1 System adoption in healthcare – to help improve both patient safety and supply chain efficiency. She fosters the development of the GS1 system by designing and helping to implement new business solutions.  Prior to starting at GS1, Tania worked for the Australian GS1 organisation, GS1 Australia, for nearly 15 years, holding various roles in that time.

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

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.

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.

 

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.

Nurettin Ekizoglu, Head Supply Chain, Novartis

 

Nurettin Ekizoglu is currently Head of Supply Chain Management at Novartis Technical Operations Turkey, with ~20 years supply chain and manufacturing experience in pharmaceuticals, medical devices and durable goods industry through various management roles in a number of countries. He holds a degree in Industrial Engineering from Istanbul Technical University, TR, and an MBA degree from Duquesne University, USA.

Sonia Bradford, Research QA, Qualified Person, Mundipharma International

 

Sonia has worked for over 20 years within the pharmaceutical industry.  After qualifying as a pharmacist, Sonia joined Napp Pharmaceuticals and gained experience within the Research and Development environment , specifically in formulation development.  Further job roles within the organisation included scale up and product transfer to production, commercial QA and responsibility for validation .  Sonia qualified as a Qualified person over 15 years ago and has worked in that role in both a commercial and R&D environment.  Her role transferred specifically to Clinical Trial activities where she has had responsibilities for quality systems for GMP and GCP activities.    Sonia now works for Mundipharma International, providing QA and Qualified Person support for clinical trials run within the organisation.

Julie Helsted-Winkel, Director, Clinical Supplies Trial Set-up, Novo Nordisk

 

Julie Helsted-Winkel has a MSc from the Technical University of Denmark in 2005. Julie Helsted-Winkel has been working for Novo Nordisk A/S for more than 10 years, 9 of them has been with different manager responsibilities in the area of Clinical Supplies.

Sophia Aman Raza Trial Label Designer, Novo Nordisk

 

Sophia Aman Raza holds a MSc. in Biotechnology from the Technical University of Denmark. She conducted her master thesis in the laboratory for Virus Research and Development at Statens Serum Institut (SSI). Sophia Aman Raza has been working with Novo Nordisk A/S for more than 2 years. She works as a Trial label designer and is the process owner of the label design process in Clinical Supplies.

Pieter Klaassen, Director, NHS

 

Pieter J Klaassen is a freelance pharmaceutical professional having spent 12 years in at a London NHS hospital. Previous roles include Pharmaceutical Manufacturing Operations Co-ordinator clinical trials. Pieter started his career in pharmaceutical sales with Apotex and Byk Gulden before moving to the UK in 1999 to join the NHS.

Pieter completed his PG Dip Pharmaceutical Industrial Advanced Training (PIAT) at the University of Manchester and also studied at the School of Pharmacy London (Qualified Person Course). Pieter is a member of Research Quality Association (RQA, International Register of Certificated Auditors (IRCA), Pharmaceutical Quality Group and the General Pharmaceutical Council and The Institute of Clinical Research (ICR).

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

Lisbeth Nielsen, Distribution Coordinator, H. Lundbeck A/S

 

Lisbeth Nielsen has 17 year experiences in Clinical Supply at Lundbeck - a specialist in brain diseases. She is a Distribution Coordinator but she has also experience with packaging. Lisbeth set up the contracts with CMO’s all over the world and collaborates with CRO’s about the distribution of IMP. Lisbeth is responsible for the setup chosen for temperature monitoring IMP at Lundbeck. Lisbeth is the GDP responsible for IMP in Clinical Supply. Lisbeth is educated as pharmaconomist and have skills from both private pharmacy and hospital pharmacy.

 

Florian Clemencon, Senior Clinical Supply Chain Coordinator, Ipsen

 

I hold a Phd in Pharmacy and a diploma in industrial engineering. I worked in pharmaceutical industry for 9 years. I’m senior clinical supply chain coordinator in IPSEN. I worked in different departments:

- Quality assurance in industrial affaires as QP and SAP Key User.

- Manufacturing and clinical supply chain. I participated to the setup of several studies from phase I to IV with oral and injectable treatments in different therapeutic areas like cosmetics, consumer health care, oncology, neurology.

Irina Kracheninnikova, Central Clinical Demand Manager, Ipsen

 

Former consultant in Project management & Supply Chain in different industries like Defense, Automobile & Pharmaceutical, I joined Ipsen beginning of 2017 as Clinical Demand Manager after a fruitful collaboration during the mission dedicated to redesign and improvement of the process of the IMP quantities estimation  for clinical studies.

Ramón López,  Clinical Trials Manager, Thrombotargets Europe

 

Medical Doctor specialized in Family Medicine

 

Clinical Research Manager, Bionure

Senior Consultant, DEP Institut

Medical Director,  Laboratorios Rubió

Medical Director,  Hartington Pharmaceutical

Medical Director, Laboratorios SALVAT S.A.

Medical Director, ConvaTec Spain (Bristol Myers-Squibb)

Medical Affairs Manager, Laboratorios Almirall

General Practitioner in Public Primary Care, Barcelona Generalitat of Catalonia

Sarah Vanrenterghem, QP Clinical Trials  / Quality Pharmacist, UZ Gent – Pharmacy/ Clinical Trial unit

 

Sarah Vanrenterghem studied Pharmaceutical Sciences at the University of Ghent and graduated as industrial pharmacist in 2007. After 6 months scolarship to be recognised as a qualified person, she continued working at Pfizer Puurs in the Quality Assurance department as a validation project engineer. In 2009 she traded the quality systems for quality operations -production and worked as release engineer at Pfizer. Her main tasks were deviation assessment, batch release, product quality review among other projects in the aseptic field. In 2014 she left the pharmaceutical industry and started working in the hospital pharmacy at UZ Ghent. Besides her responsibilities within quality for the pharmcy, she also acts as the qualified person for clinical trials. Together with the clinical trial units at UZ Ghent we have extended our GMP-license for production of non-sterile dosage forms in clinical trials to the production of sterile (i)ATMPs in 2016 and the production of sterile investigational radiopharmaceuticals in 2017.

Florence Guiraud, Trial Supply Operations Manager Leader, Sanofi R&D

 

Florence Guiraud is Trial Supply Operations Manager Leader within the Clinical Supply Chain Operation at Sanofi. Florence has worked for over 20 years within the Pharmaceutical Industry. Before moving to the Clinical Supply unit in 2011, Florence was working as Clinical Project Leader for the French Clinical Study Unit of Sanofi. She started working within Pharmaceutical Industry as Regulatory Affairs manager for South-East Asian countries. Florence Guiraud is graduated in Health Engineering from the University of Pharmacy of Montpellier (France) and has a Post graduate diploma in health law from Law School of Sceaux (France). She is based in Montpellier.

 

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