For the 4th time on 26-27 February 2014  
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Programme Advisory Committee

Dr. Zsolt Szombathelyi, Global Research Director, Gedeon Richter

Dr. Zsolt Szombathelyi graduated from the Semmelweis Medical University in Budapest at the Faculty of Medicine in 1981 as a Medical doctor. He started his career in 1981 as a Researcher Pharmacologist at Gedeon Richter. Between 1992 and 1993 he was the second secretary representative of RND connections at the Hungarian Embassy within the Commercial Section Tokyo in Japan. Between 1993 and 1998 he was the Representative Director at Medimpex Japan Co. Ltd. in Tokyo.
Since 1998 Dr. Zsolt Szombathelyi is working for Gedeon Richter again, first as the Director Pharmacological and Drug Safety Research later as Director Biomedical research and since 2001 he is holding his current position as the Director Research with a global responsibility.


Wojciech Kisielnicki, Supply Chain Director, Polpharma Group


Wojciech Kisielnicki, Supply Chain Director, is responsible for management of Polpharma Group end-to-end supply chain. He started his career in 90’s as a management consultant, undertaking process reengineering and privatization projects. Since eleven years he has been developing SCM function of Polpharma, the leading Polish pharmaceutical company, facilitating rapid growth across domestic and international operations. Wojciech has also been working for several years on development of materials management best practices in affiliated pharmaceutical plants and companies.


Endre Kollár, Director of Production Group Germany-Italy-India, Sanofi

Endre Kollár graduated in Chemical Engineering from the Budapest Technical University in 1987 and received his MBA in Economics in 2000. He started his professional career at Sanofi in 1985 and gained experience in several management positions, such as Production Section Leader (Fermentation Upstream), Plant Manager (Fermentation Upstream), Chemical Development Project Manager responsible for the launch of new molecules from laboratory to industrial sale, Plant Manager of the Synthetic Chemical Plant, Deputy Director of Chemistry and Director of Chemical Site in Újpest.
Since 2012 Endre Kollár is holding his current position as the Director of Production Group Germany-Italy-India and is the Associate Vice President of Chemistry-Biochemistry, located in Paris.


Dr. Csaba Szőke, Global Advanced Sterile Technologies and Operational Excellence Director, TEVA

Dr. Csaba Szőke graduated from the Semmelweis Medical University in Budapest as a pharmacist in 1989 and received his doctor’s degree in pharmaceutical technology and microbiology in 1996. Since 1989 is working for TEVA in various positions, such as Production Pharmacist, Chief Head of Freeze-drying section, Head of Injection plant, Division head of Sterile Pharma Production Division and Sterile Pharma Production Director. Since September 2012 Dr. Csaba Szőke is holding his current position as the Global Advanced Sterile Technologies and Operational Excellence Director and is responsible for controlling, supporting sterile production sites professional operation, leading new advanced sterile production processes and aseptic technologies development and implementation.


Petr Daniel, Quality Assurance Manager, Roche

Petr Daniel graduated in Molecular Biology from the Charles University in Prague and from the Technical University in Liberec in Business Economy. Afterwards he gained experience in the local Health Authority, The Institute for Drug Control (SUKL) as an Inspector of Clinical Trials for two years. Then he joined Lonza Biotech and was the Head of Microbial Laboratory for three years. For the five past years Petr Daniel has been working in his current position as the Quality Assurance Manager in the Czech affiliate of Roche, responsible for the Quality Systems (GDP and GMP) maintenance and also for releasing drugs to the local market.


Ernő Duda, President & CEO, SOLVO Biotechnology & President of the Hungarian Biotechnology Association (HBA)


Ernő Duda received his degree in management studies at the Euro-Contact Business School in Budapest and started his career as the founder and CEO of Copy General, Hungary, which became the largest chain of photocopiers in Hungary.

In 1996 he founded LP Invest, a corporate finance consulting company which focused on start-ups in lifescience and IT-sector. As the Managing Director he negotiated and concluded several high-tech investment deals. In 1999 Ernő Duda founded SOLVO Biotechnology which became the largest independent biotech company in Hungary with clients including the top 20 international pharma and biotech companies. As President and CEO of SOLVO Biotechnology he managed several VC investments. In 2002 Ernő Duda founded the Hungarian Biotechnology Association and with his team of experts he developed the Hungarian government's five-year, national biotechnology strategy. He also initiated and manages the "BioManager", a one-year training programme for young scientists interested in the business aspects of life-sciences.

In 2009 Ernő Duda received the Honorary Associate Professor title granted by the University of Szeged for his significant input into higher education.


Miroslava Čikošová, Head of Manufacturing, Lonza Biotec

Miroslava Čikošová graduated from the Comenius University in Bratislava in molecular biology at the Faculty of natural sciences in 1993. She started her career as a Process Technologists in 1993 before she became the Head of the Fermentation Division at Biotika a.s. in 2000 and the Head of the Pilot Projects Department in 2004.  In 2005 Miroslava Čikošová continued her career at Lonza Biotec s.r.o., first as Senior Process Technologist and R&D Manager, before she was promoted to the Head of Manufacturing in 2011. In her current position she is responsible for 170 employees, the development of the new organisational structure in manufacturing, the development and improvement of the systems used in manufacturing, the direct interactions with internal and external customers, the manufacturing plans preparations, and the campaign and annual reports review.


István Király, Managing Director, GSK Biologicals

István Király graduated from the Technical University in Budapest as a mechanical engineer. During his professional career he has filled several technical- and production -related management positions in different industries at large international companies such as General Electric, DANONE, Alcoa and GlaxoSmithKline. These challenges allowed him to be involved in the implementation and operation of different management and quality systems such as ISO, HACCP, GMP, Toyota Production System, Six Sigma and Lean Sigma. In 2006 he joined the company GSK Biologicals Kft. located in Gödöllő, Hungary as Technical Services Senior Manager. He was responsible for maintenance, calibration and investment projects, Energy Management, Validation and EHSS in this position. Within the first year István Király successfully reorganized the technical services, turning it into a customer- and quality -focused organization ensuring the robust operation of the site. Later he was appointed to the QA Senior Manager position and in December 2011 he was promoted to the Managing Director of the Gödöllő site.


Amer Alghabban, Director, Global Quality Assurance Auditing, Merck Serono

Amer completed his M.Sc in Pharmacology at Bradford University, Postgraduate studies in Medical Sciences at University College Hospital, Diploma in Biological Sciences from Salford University and Postgraduate Certificate in Clinical Research from Surrey University. 
Amer has over 20 years track record in the pharmaceutical industry (spent within Clinical Development, Quality Assurance, Pharmacovigilance, Medical Information, and Medical Communications). For some time, he was the Assistant Editor for 11 medical journals. He contributed further to these disciplines by writing The Pharmaceutical Medicine Dictionary in April 2001 and The Dictionary of Pharmacovigilance in May 2004. He is currently writing his 3rd book, Dictionary of Clinical & Pharmaceutical Development.
Amer is currently the Global Director of Audit Management at Merck Serono, Geneva, Switzerland. Prior to his current position he was the Global Head of GxP (GLP: GMP & GCP) Quality Assurance at Arpida Ag., Switzerland. His previous positions include: Senior International Clinical Quality Assurance Auditor at Novartis Pharma Headquarters in Switzerland and he was the first Pharmacovigilance Compliance Coordinator of the Medicines and Healthcare products UK Regulatory Agency (MHRA).
In these roles, Amer conducted a vast number of audits including a spectrum of GCP, Pharmacovigilance, Clinical Laboratories, GLP, GMP, Vendor, Protocol, Clinical Study Reports, Due Diligence, Fraud investigation and Databases audits. He is certified as a Lead Auditor by the International Register of Certified Auditors.
Amer is a regular lecturer on the M.Sc in Pharmacovigilance course at the University of Hertfordshire. He also served as an Executive Committee Member of International Society of Pharmacovigilance (ISoP) and the Good Pharmacovigilance Practice Committee of the British Association of Research Quality Assurance (BARQA), and is a member of the Society of Pharmaceutical Medicine, Associate of the Institute of Quality Assurance (IQA), DIA, Member of the Association of Clinical Research Professional (ACRP), and the Organization for Professions in the Regulatory Affairs (OPRA). Also a member of CMO Outsourcing & Management, QA & RA Network.


Prof. Ádám Vas, M.D., Ph.D., Senior Research Adviser, Gedeon Richter

Professor Vas holds a degree in medicine and clinical pharmacology. He got his PhD degree in the pharmacogenetic background of hepatic drug metabolism. Dr. Vas is part-time Professor at the Szeged University, I. Department of Medicine teaching clinical pharmacology. He is officer of the European Association for Clinical Pharmacology and Therapeutics (EACPT), Head of the Scientific-Engineering Committee of the Hungarian Pharmaceutical Manufacturers Association, Leader of the Hungarian Innovative Medicines Technological Platform and member of the EU Innovative Medicines Initiative Scientific Committee among other positions.


Prof. Tamás Paál, External Adviser, National Institute of Pharmacy Directorate & Professor emeritus at the Institute of Drug Regulatory Affairs, University of Szeged

Prof. Tamás L. Paál holds a degree in Pharmacy and Chemical Engineering. After spending eleven years in the Hungarian pharmaceutical industry Prof. Paál joined the National Institute of Pharmacy, the Hungarian competent agency for human medicines. Prof. Paál was Director-General of the Agency for 23 years. Having reached the age of 65 when such appointments expire in Hungary, he performs an advisory role in the capacity of President of the Scientific Board to the same Agency. Prof. Paál is also part-time professor at the University of Szeged, Hungary, teaching regulatory affairs and quality assurance.


Dr. Richard Schwab, Medical Director, KPS DIAGNOSTICS and Organization Development & HR director, TriGranit

Dr. Schwab is founder and medical director of KPS Diagnostics, one of the first companies to offer molecular diagnostic services in the field of oncology. KPS was also among the first companies to attract venture capital: PortFolion Corp. has acquired minority ownership in the company to finance international expansion. He spent several years at universities of Basel, Vienna and London and authored several international articles and patents. He made significant contribution personalized therapy of lung cancer and authored publications in top international peer reviewed journals as well as patents. He earned his degree at Semmelweis University in 1995 and has board exams in internal medicine and in gastroenterology and graduated in a master’s program in business administration from CEU and Purdue University in 2008. Dr. Schwab has significant achievements in personalized medicine from a bench-to-bedside perspective.


Dr. Sergei Sur, R&D Director, Arterium Corporation  


Dr. Sur has over 25 years of work experience in the pharmaceutical market, including 14 years in management positions. He received his PhD degree in Pharmacy and published about 100 scientific publications. Between 1993 and 1998 he was the Head of State Laboratory for Quality Control of Medicines at the Institute of Pharmacology and Toxicology at the Ukrainian Academy of Medical Sciences in Kiev. Between 1998 and 2005 he was working for the Ukraine Ministry of Health, first as the Director of Central Laboratory for Quality Control of Medicines and since 2000 as the Deputy Chief Inspector for Quality Control of Medicines. Since 2005 Dr. Sur is in his current position responsible for the development of a functional strategy in R&D; the development and introduction of R&D business processes and structure; and the organization of research, development and registration of new products. Additionally Dr. Sur is a member of the International Federation of Pharmacists (FIP) and since 1998 an adviser on International Pharmacopoeia and Pharmaceutical Preparations and since 2002 also on Traditional Medicines for the WHO headquarter in Geneva. 


Dr. Péter Lakatos, Member of the Presidency, Hungarian Logistics Association (HLA) & former Head of Logistics Centre, TEVA


Dr. Péter Lakatos is a certificated economist and Leader in Military Logistics. Between 1983 and 1997 he worked in different positions at the Military of the Hungarian Home Defence Forces. Between 1997 and 2002 he held several positions at Tesco Global Stores Plc. and started as a Training and Stuffing Director. Later he became the 3PL Manager and was responsible for the non-food distribution and was involved in the introduction of cross-docking under an outsourcing contract. Later he held the position as the Director of the public bonded warehouse of Menlo Worldwide Hungary Ltd. and Managing Director of Den Hartogh Ltd. Between 2006-2011 Dr. Péter Lakatos was the Vice-President of HLA, issued more than 30 publications and was chairman at several conferences. Until April 2012 Dr. Péter Lakatos was heading the TEVA Logistic Centre at TEVA Hungary Plc. in Hungary. Currently he is active as an Associate Professor at the College of Szolnok, guest speaker and instructor at the Selye János University, the Budapest College of Management and the Budapest College of Communication and Business. In addition, as an expert in logistics he is also an active member of HLA and member of the HLA Presidency.

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