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CSS 2019 8th Annual Network

 Speaking Panel

Fabian De Paoli holds a Master Degree in Applied Biology from the Catholic University of Louvain-La-Neuve, a degree in Management Mastery from EPM, as well as a degree in electro-mechanic engineering from the ECAM, Brussels.

Since 1984, Fabian has held several positions at GSK Vaccines with responsibilities in the areas of Production, Quality Control, Engineering and Manufacturing Centre of Excellence. He spent the last 15 years in Packaging, Warehousing and Cold Chain activities. In his current position, as Director Vaccine Distribution and Cold Chain, he is in charge of the development of standards; qualify solutions and improvement of processes in the area of cold chain, storage/warehousing and distribution activities.

Fabian is a member of the PDA Pharmaceutical Cold Chain Interest Group (PCCIG) – European Branch.  He is the co-author of a peer-reviewed article on PDA TR 53 Guidance for Industry “Stability testing to support distribution of new products. He represented the Industry on the Packaging working Group (WHO).

 

Co-Chair

 

Francesca Burberi 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.

 

Co-Chair

 

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.

Markus Haase, International Sr. Market Manager – Solutions Division, Testo

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.

Thomas De Bie was appointed CEO of CAPPI on 1 February 2016. His early career was spent in sales and marketing and spearheaded CAPPI’s European expansion. He holds a Master of Science in International Business. Dutch from origin, Thomas lives and works in France since 2006.

Yoram Eshel, I bring more than 30 years’ experience in all areas of Global Transportation and Logistics. In the last 14 years,  I proudly led the Global Logistics Network of Teva Pharmaceutical Industries. Direct responsibility for budget of more than 300M$ with more than 100 direct employees all around the world. I gained extensive knowledge and experience in all areas of Logistics, in all modes of Transport including Customs and Trade compliance. Prior to Teva, I spent 5 years in the US - managing several areas of Logistics following 9 years as senior manager in one of the leading Forwarding companies in Israel. During these years I initiated and led many initiatives including process improvement, cost savings (>10M$ YoY), Network Optimization, Distribution and “last mile” solutions, Optimize routs and Logistics networks and implement advanced IT solutions. I led the procurement and the business partnerships with the Top Global Logistics service providers and carriers with strong Customer Service orientation and cross function business Collaboration. After retiring from Teva, I founded “Loginor” – aimed to provide smart logistics solutions and consulting services, in Israel and abroad, in wide range of sectors like: Logistics, Pharma, Investment Funds, Hi-Tech and more.

 

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.

Marloes Seesing, with a degree as pharmacist Marloes (Pharm D, University of Groningen, the Netherlands) has extensive experience in Quality and Operational Departments worldwide within the pharmaceutical and healthcare industry, particularly in LATAM (Latin America), APAC (Asia and the Pacific), Europe and the US. The appointment of Marloes establishes a central point of contact across an international network, with the primary focus of aligning Yusen’s Global GDP compliant network. Marloes will be leading a dedicated unit committed to achieving global quality standardisation across Yusen Logistics, with the aim of consistently providing first rate quality service to customers and patients as standard.

Andrea Zangara holds a MSc degree in Phytotherapy (University of Barcelona). He has more than 20 years of international experience in pharmaceutical and nutraceutical research and development, holding positions in Academia and the Industry. Since 2017 he is Scientific Marketing Manager at Euromed. He is Adjunct Research Fellow at Swinburne University, Australia, and collaborates with several international expert groups with focus on quality control in herbal medicines. He is author or co-author of over 30 between research papers, review articles, book chapters or books

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.

Amer Alghabbar is currently the Managing Director of GxP Compliance and Training Partners (GCTP), which he founded, helping pharmaceutical companies to achieve compliance with GCP, GVP, GCLP, GDP and GLP.

Amer, a Clinical pharmacologist by education, has over 28 years’ experience in the pharmaceutical industry. He has been an invited speaker at over 120 international congresses. Mr. Alghabban has published reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Earlier in his career, he was Assistant Editor for 11 medical journals and invited Course Director for The Pharmacovigilance Auditing Course at the RQA. As part of his current role as QA Expert, he is serving as Head/Representative of QA & QA Consultant of several Biotech companies worldwide.

His other previous positions included: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. Boston, USA, Global Director, Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.

 

Petra Zartner studied in Pharmacy- FU Berlin

Thesis in pharmaceutical chemistry FU Berlin

Working in pharmacies, focus on QA and pharmacological questions

Since 2011 in pharmaceutical industry

Focus mainly on QA/QC and Pharmacovigilance

 

Ben van Beek built experience over 30 years in Pharmaceutical industry in roles of increasing responsibility on National and International level in validation, quality management, quality systems and GDP. In his career he acted as Qualified Person for EU release, headed  quality groups both on national and  global level for manufacturing organizations, in market QA groups and supply chain hubs.  In his current work as independent consultant he works with clients from manufacturing-, logistic organizations and in-market Quality Assurance  within the EU to implement and improve quality systems and prepare the organizations for regulatory inspections by international inspectors.

 

BD van Beek Quality Consultancy

Snežana Večerkov Vukmirović is External Site Quality Lead at Merck Sharp &Dohme. Snezana brings broad base of professional experience within pharmaceutical industry with more than 25 years on various challenging and positions with increasing responsibility in technology transfer, validation, quality assurance and auditing. She joined Merck Sharp &Dohme in 2013 and as subject matter expert provide expertise in implementation of new GDP requirements in legal supply chain in CEE and provide support in quality matters related to SAP. Since 2018 she is member of MSD External Quality Assurance team supporting Russia, Ukraine, Kazakhstan and CIS countries.

Snezana holds Master degree in Pharmaceutical science from the University of Belgrade and executive Master in International Management and Economy from HEC, Paris. She is certified Industrial Pharmacist and Qualified Person by Serbian Health Authorities.

 

 

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