Faculty

Adrian Streinu-Cercel, Prof., PhD - INBI Matei Balş (Romania)

Prof. Dr. Adrian Streinu-Cercel, MD, PhD, born in 1956, Acad. Professor of Infectious Diseases, Chancellor at the “Carol Davila” University of Medicine and Pharmacy, Bucharest, General Manager of the National Institute of Infectious Diseases “Prof. Dr. Matei Balş”, with experience as director of 4 international research grants and member of the research team in other 11 international grants; project director in one national research grant and a member of the research team in other 7 national grants; principal investigator in 30 multicentric international clinical trials. Editor in Chief for several Infectious diseases publication in Romania: the Romanian language edition of “Clinical Infectious Diseases Journal” – Oxford University Journals, since December 2010, The Lancet Infectious Diseases – Romanian language edition, the journal Therapeutics Pharmacology and Clinical Toxicology, since 2006, and for the journal GERMS – since 2011, the official journal of the The European HIV/AIDS & Infectious Diseases Academy, as Dr. Streinu-Cercel founded this academy in june 2009, as a post-graduate training and education facility providing direct access to various types of services currently offered by its network members. The HIV European Academy was listed in the five post university schools approved in Romania by the Ministry of Education The European HIV/AIDS & Infectious Diseases Academy aims to provide direct access to knowledge and practice in the area of treatment and care at the highest standards for health, social and education professionals. The Academy has numerous partnerships with important institution from all over Europe and USS. (more than 15 countries from CEE regions are affiliated) www.aidsacademy.org.

Cristina Florescu-Moraid, MD, MSc, EurClinChem – Synevo Central Lab (Romania)

Clinical Research Country Manager and Business Development Responsible for developing and extending clinical research business in Romania and expanding research activity in international projects where included sites from Romania and surrounding countries such as Moldavia, Hungary, Bulgaria, Serbia; developer of clinical research training programmes and implementing them in Romania for specialists involved in clinical research bussiness (i.e.investigators, clinical research associates, laboratory specialits, etc).

Project manager for over than 60 studies, phases I-IV, predominant for phase II and III projects where fulfilled the role of central , regional and local laboratory together with partners as: Roche, Pfizer, PSI Pharma Support, Kendle International, MDS Pharma, Covance, Johnson and Johnson, Active Biotech, Arpida International, Cerexa Inc., Biogenerix, Bristol Myers and Squibb, M and M CRE, Pharm Olam International, Eli Lilly, Astra Zeneca, Merck Sharpe and Dohme, Merck KGaA, INC Research, I3Research, Quintiles, Wyett, Sanofi-Aventis, Focus BioInova, Parexel International, Chiltren, Encorium, Kendle International, Argint International, Cardiokine, Neurocrine, Sandoz GmbH, Hoffmann La Roche, Immatics, Ziopharm International, Amgen, Cosmo SpA, Servier, Takeda, Centocor, abCRO, Uteron, Human Genomics, Genexion, PRA International, Quail, Romark Institute for Medical Research, Bayer Schering Pharma, Novartis, Ascent, Pharma Net, Zentaris, Berlin Chemie, LabConnect, Comac Medical, Accelsiors, Chorus Lilly, Isis Pharmaceuticals, American Bioscience, Novexel, etc.

Gail Adinamis, CEO – GlobalCare Clinical Trials (USA)

Gail Adinamis provides vision, leadership, strategic planning and oversight for GlobalCare Clinical Trials, Ltd. Ms. Adinamis is an accomplished executive with over 30 years of comprehensive phase I-IV clinical trials experience, including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. Ms. Adinamis founded the business model for centrally managed in-home and alternate site services for clinical trials in 1992. Ms. Adinamis is an industry thought leader and has spoken at over 25 industry conferences. She is an entrepreneur with strong business development and operational expertise along with a proven track record for success. She established and headed clinical trials divisions for three national home infusion companies. She was also the founder, President and CEO for a niche clinical trials service organization providing a mobile network of clinicians to speed patient recruitment and increase compliance and retention for sponsored clinical trials. Ms Adinamis was recognized for two consecutive years by INC 500/5000 as being among the leaders of the top 5000 fastest growing private companies in the United States.

Janusz Kabata, MD, PhD, MBA – Global Care Clinical Trials (UK, Poland)

Janusz Kabata provides global operational management and medical oversight for GlobalCare Clinical Trials, Ltd. Dr. Kabata is a specialist in laboratory medicine and public health and brings over 30 years experience as an academic researcher and Medical Director in private healthcare institutions. He was associate professor at Gdańsk Medical University, Visiting Professor in the Department of Hematology at Basel University, Switzerland and Polish coordinator of TEMPUS Join European Project. Dr. Kabata also has 20 years experience in coordination and management of international clinical trials. He currently serves as Director of Postgraduate Programs for Clinical Trials Management Development at Gdańsk Medical University and Gdańsk Foundation for Management Development. He was the founder of Nova Medical Polska, first private Polish-Swedish, clinical laboratory, that provided central laboratory services for more than 200 phase I-IV clinical trials in Central and Eastern Europe. Since 2008, he has managed the provision of ambulant care services in Europe, Israel and Australia and currently serves as Director of Postgraduate Programs for Clinical Trials Management in Poland and Romania.

Mariusz Kardaś, MSc, MBA – GFKM (Poland)

Mariusz Kardaś is a Project Management consultant since 1999. He graduated from Economics at the University of Gdańsk (Foreign Trade department) in 1993.

In 1993 he won business scholarship of Danish Agency for Industry and Trade Development (preparation to manage a branch of the Danish company in Poland). During the studies (1993-1994) he graduated a course “Marketing & Logistics for Managers from Baltic Sea Region” and completed a workshop “Business Management”.
In 1995-1999 he was leading Polish branch of Danish company H.J. Hansen Genvindingsindustri A/S, dealing with Recycling business. He was a leader of some projects connected with implementation of modern systems for recycling business (e.g. production, logistics). In 1999 he had completed post-graduate MBA program in GFKM, certified by University of Strathclyde (Glasgow).

Mariusz is an author and trainer of various Project Management programmes. He introduced and manages Post-Graduate Project Management Studies provided by GFKM in cooperation with a leading Polish private university – Leon Koźmiński Academy (Warsaw). He is a Project Management lecturer on post-graduate MBA programmes (Gdańsk, Business Centre Club).

He is a member of Project Management Institute (USA) and IBM Project Management Club (Poland). Mariusz cooperates as a trainer and consultant with many companies based in Poland, both international and Polish.

Andrzej Popadiuk, MBA – GFKM (Poland)

Andrzej Popadiuk is a member of the Board and a Director of Executive Education at Gdańsk Foundation for Management Development.

As a trainer, consultant and coach he specialises in developing leadership competencies, such as transformational leadership, team management, coaching, communication, motivation, negotiations, problem solving and decision making. Over the last 15 years he has worked mainly with senior and middle management of multinational organisations. His practical approach and focus on results have enabled him to promote effective leadership practices and promote pro-effective corporate culture in a number of client organisations.

Some of the companies that he has worked for as a consultant, trainer and coach include ABB, Allianz, BMW GB, ComputerLand, Eaton Truck Components, Federal Mogul, Fiat Auto Poland, Flextronics, FM Logistic, Heineken, International Paper, Janssen-Cilag, Kimberly-Clark, Lloyd’s Register, Matsushita, Mediaedge:cia, Millennium Bank, Nestlé, Nordea Bank, Philips,  Polish Airlines, Roche, SGS, Unilever,  Wavin, Wrigley.

Being a former business practitioner and a graduate of the MBA Programme at Strathclyde University, he is a tutor on the MBA Programme, Executive Management Studies, and other postgraduate and executive programmes at the Gdansk Foundation for Management Development. He delivers workshops for MBA students and administrative staff at European Universities.

He is a member of the board of European Quality Link (EQUAL) in Brussels and a member of the European Program Quality Accreditation Committee (EPAS) in Brussels. He chairs and is a member of accreditation teams for European Foundation for Management Development (EFMD) and Central and East European Management Development Association (CEEMAN) evaluating management programs in Europe and elsewhere. He  is  a guest speaker and a chairperson at conferences on leadership, business coaching, and management education.

Prof. Michał Markuszewski, PhD, MSc – Medical University Gdańsk (Poland)

Michał Markuszewski is associate professor at Department of Biopharmaceutics and Pharmacodynamics of Medical University of Gdańsk. His main scientific interest is application of novel scientific approach called metabolomics in biomarkers discovery and drug development. Dr. Markuszewski also has more than 10 years of experience in clinical studies, mainly bioavailability and bioequivalence. He is a specialist in pharmacokinetics and separation sciences. Dr. Markuszewski gained international experience working as a researcher and teaching assistant in such institutions as: Himeji Institute of Technology (Japan), Bremen University (Germany), Eindhoven University of Technology (The Netherlands), Vrije University in Brussels (Belgium) and Biopharm Research (Poland). He is author and coauthor of ca. 50 articles published in scientific journals and 5 chapters in books.

Teresa Brodniewicz, MSc, PhD – MTZ Clinical Research (Poland)

Dr. Brodniewicz  has served as Vice President and Director of Scientific Affairs and Development since  MTZ Clinical Research foundation in Warsaw, Poland, in 2002. In 2008 she became  the President of the Company while still directing research and development. From 2002 through 2011 she has been leading the Company’s growth from a small research site to the leading Polish CRO specialized in Early Development clinical trials.

Dr. Brodniewicz graduated from the Lodz University with MSc degree in Biology, and received her PhD from the Institute of Biochemistry and Biophysics of the Polish Academy of Sciences in Warsaw, Poland, in 1980. In 1981 she was a Postdoctoral Fellow at McGill University in Montreal, Canada, and later on at Armand Frappier Institute, Laval, Canada. In 1982 she assumed her responsibilities as Scientific Director at Armand Frappier Blood  Fractionation Center, Laval, Canada.  In 2001 she became Vice President and CSO of Haemacure Corporation, Montreal based biopharmaceutical company developing tissue adhesives.  At that time she became an opinion leader in her area of expertise.  In 1997 she became  Director  of Clinical  Operations at Parexel International responsible for establishing clinical research operations in Central and Eastern Europe with the main office in Warsaw, Poland. Later on she led business development activities for PAREXEL, mainly in the area of biopharmaceuticals. In 2002 she cofounded MTZ Clinical Research.

She is the  author of publications in the area of plasma fractionation, blood coagulation factors in such scientific journals as: Nature, Blood Reviews, Vox Sanguinis, Thrombosis and Haemostasis.

She delivered numerous lectures and workshops in the area of blood plasma fractionation, viral safety of blood derivatives, tissue sealants and clinical research.

Tomasz Dyszyński, MD – Bayer Healthcare (Germany)

Tomasz Julian Dyszyński graduated from Warsaw Medical University and got the degree of Doctor of Medicine at the Ludwig Maximilian University of Munich. He completed elementary and advanced postgraduate courses in Epidemiology and Pharmacoepidemiology at the McGill University in Montreal and postgraduate study courses on Pharmacoeconomics, Marketing and Pharmaceutical Law at the Business School of Technical University of Warsaw. He received his basic postgraduate medical training at several teaching hospitals in Warsaw and 3-year training in vascular medicine in the Internal Medicine and Vascular Out-Patient Clinic of Professor Marshall in Tegernsee in Germany. At that time he was a co-investigator responsible for the execution of a single-centre, Phase-III clinical trial for the Schwarz Company.

Since 1997 to date he has been working for Bayer HealthCare, initially as a co-ordinator of clinical trials in the office of the Regional Medical Director Eastern Europe & Middle East, and subsequently being involved in different aspects of study management including monitoring, study set-up and management, co-ordination of study-drug supplies and pharmacovigilance. In 1999 he resumed the position of Local Drug Safety Manager in Warsaw and from 2003 International Drug Safety Manager and Global Safety Leader in Wuppertal and Berlin.

His professional accomplishments include successful establishing and leading the Local Drug Safety Office at Bayer in Warsaw, execution of pharmacovigilance activities on local and global level for more than a decade. He led a local study team of 10 monitors of a large outcome study in Poland, authored several study protocols and set up demanding Phase-II cardiovascular studies. As a board member of the Good Clinical Practice Society in Warsaw, he provided input to the local legislation implementing the Good Clinical Practice into the Polish law. He authored several original articles and chapters in two Polish handbooks in the area of pre-marketing and post-marketing pharmacovigilance. Since several years he has been providing lectures and seminars on pharmacovigilance among others for Medical Universities of Gdańsk and Warsaw.

He is member of the Society for Good Clinical practice in Poland (board member 2002-2004) and International Society for Pharmacoepidemiology.

Julian V. Platon, MD, PhD – Abbott Products Operations AG (Switzerland)

Dr. Platon has been born in Bucharest, Romania in 1963. After his A Level in Bucharest he relocated to Germany in 1983 where he obtained the German Matura and studied Medicine in Cologne, London and Beer-Sheva. In parallel to his Conferral of Doctorate in Surgery he worked as a physician in the Department of Internal Medicine in Cologne, Germany.

Since 1994 Dr. Platon had different national and international, operational and executive medical positions in the Pharmaceutical, Medical Devices and Clinical Research Organization industry in Germany, USA and Switzerland. A special focus was addressed to Medical Affairs, Clinical Operations and Pharmacovigilance (incl. QPPV). Stations of his professional life were ISIS, Hoffmann-La Roche, Abbott, PharmaPart, Solvay and Alexion. He has been a Guest Lecturer at the University Duisburg-Essen, Germany, for the Postgraduate Study Course: Master in Science of Pharmaceutical Medicine; Courses of lectures: “Production and Batch Release of Study Medication” and “Special Populations in Clinical Trials”.

Camelia Ghitan, MD, BBM – International Pharmaceutical Company (Romania)

Camelia Ghitan is an experienced Medical Doctor; currently works as a Clinical Research Consultant at the International Pharmaceutical Company. She has experience in therapeutic areas such as: neurology, cardiology, metabolism (diabetes), oncology, rheumatology, anti-infective therapies, intensive care, liver transplantation, pediatric trials.

She worked for such organizations as: International Contract Research Organization (Regional Manager, Project Manager, Clinical Research Consultant), Regional Central Laboratory services provider (Clinical Research Consultant), International Pharmaceutical Market Research Company (Head of Representative Office).

Adina Pîrvu, MD – National Agency for Medicines and Medical Devices (Romania)

Adina Pîrvu has a medical background and 10 years of experience as GCP inspector at the Romanian National Agency for Medicines and Medical Devices.

She plans, organizes and conducts GCP national inspections.

She is European Medicines Agency (EMA) expert in GCP inspection field and she conducts inspections as lead inspector in Centralized and Decentralized Application Procedures GCP inspections.

Mirela Vita, MD – National Agency for Medicine and Medical Devices (Romania)

Graduate from the Bucharest University of Medicine and Pharmacy, the General Medicine Faculty, double specialisation in Internal medicine and Clinical Pharmacology.

For 10 years working with the National Agency for Medicine and Medical Devices, firstly involved in assessment of medicinal product information in the SmPC, leaflet, clinical trials and pharmacovigilance bureau and further employed in clinical trials assessment and authorisation, with 4 years experience in the field.

As part of her activity, Dr. Vita is involved in the process related to set up of legislation, at the same an active member in working groups related to clinical trials on European level.

Cristina Constantinescu, MD – Academica (Romania)

Cristina is a Medical Doctor with the speciality in Pediatrics. She has a clinical experience in several hospitals in Bucharest and extensive experience in different areas of the pharmaceutical field across Romanian market (product management, sales management, marketing management, training, clinical studies). Cristina also has administrative management experience in healthcare (private medical clinics).