Synevo Clinical Trials Symposium 2018

Synevo Clinical Trials Symposium 2018


Dear colleagues and friends,

I am pleased to invite you to the 10th edition of the Synevo Clinical Trials Symposium, event organized in Bucharest, Romania, on November,9th 2018.

This year's edition is a special one, as we will be celebrating ten years since we initiated the first round table dedicated to clinical trials in Romania and since the idea of organizing this event has been given birth.

As in the past years, the symposium is dedicated to professionals in the field of clinical studies (doctors-investigators, specialists in various medical fields, specialists in Laboratory Medicine-physicians, chemists, biochemists, biologists, representatives of Clinical research Organizations CRO and the pharmaceutical sponsor companies), but also representatives of other companies related to the field of medical and life science research. .

Very well-known lecturers, key opinion leaders in the fields in which they activate, will present very interesting topics, as they have done in all our past editions.

For this anniversary edition, we have the honour and joy of having with us and celebrating all partners and contributors who have been with us over the years, true models to follow, specialists in clinical trials with great experience from who we have learned a lot, that inspired us and contribute to the development of the Synevo Clinical Research team.

The event is credited with EMC credits.

We look forward meeting you on November 9th, 2018 at the Intercontinental Bucharest Hotel! We promise you an unforgettable day!.

Best regards,

Dr. Cristina Florescu Moraid, MSc, EuSpLM, MRQA

Regional Director for Romania, Moldova, Bulgaria & Serbia

Synevo Central Lab

Cristina Florescu Moraid, Md, Msc, EuSpLM
Regional Director Romania, Moldova, Bulgaria and Serbia Synevo Central Lab

4

Sectiuni

18

Lectori

600

Participanti

10

Tari participante

10

ani de traditie

AGENDA

  • 08:00-09:00REGISTRATION AND WELCOME COFFEE

    Ronda Hall, INTERCONTINENTAL Hotel
  • 09:00-09:15 OPENING AND WELCOME SPEECH

    Dr. Cristina Florescu Moraid, MSc, EUSpLM, MRQA - Regional Country Director, Synevo Central Lab
  • 9:15-11:15 Session ONE

    Moderator
    Benedikt von Braunmuehl - CEO Medicover Diagnostics Services - Germany

    Moderator
    Rainer Metzger, - General Director Synevo Central Lab International-Germany

    1. Prof. Dr. Giuseppe Lippi - Full Professor of Clinical Biochemistry University of Verona | UNIVR · Department of Neurological, Neuropsychological, Morphological and Movement Sciences, Italy
    TITLE: "Blood sample quality: an everlasting challenge?"(9:15-9:40)

    2. Prof. Dr. Dunja Rogic PhD - Clinical Institute of Laboratory Diagnostics, Clinical Hospital Center Zagreb, Croatia
    TITLE: "The postanalytical phase - an ongoing challenge for laboratory profession"(9:40-10:05)

    3. Prof. Dr. Trefor Higgins - Section Chief, Clinical Biochemistry, Alberta Zone North, Alberta Public laboratories. Clinical Professor, Department of Laboratory Medicine and Pathology, University of Alberta, Canada
    TITLE: "Reference Intervals: Should we pay more attention to how they are calculated?" (10:05-10:25)

    4. Prof. Dr. Michael Oellerich - MD, PhD - Professor of Clinical Chemistry at the Medical Faculty, George-August - University Göttingen, Germany
    TITLE: "Circulating cell-free DNA – a promising tool in cancer and transplantation” (10:25-10:50)
  • 11:00-11:30MORNING COFFEE AND NETWORKING BREAK

  • 11:30-13:30 Session TWO

    Moderator
    Julian Platon - Head of Medical and Clinical Affairs, Luye Pharma, Elvetia

    Moderator
    Janusz Kabata - CEO GP4Research, Poland

    1. Dr. Florina Prundaru - Clinical Research Director, Romania and Bulgaria, Merck Sharp & Dohme
    TITLE: "Competitive Advantages of Romanian Clinical Research Market" (11:30-11:50)

    2. Adam Niels - Head of Laboratory Support Services, PSI CRO Deutschland GmbH, Germany
    TITLE: "The PSI Approach to Harmonizing Local Laboratories in Clinical Trials" (11:50-12:10)

    3. Dr. Julian Platon - Head of Medical and Clinical Affairs, Luye Pharma, Switzerland
    TITLE: "Ethics and Vulnerable Groups in Clinical Trials"(12:10-12:30)

    4. Janusz Kabata - MD, PhD, MBA, CEO GP4Research, Poland

    TITLE: "Pragmatic, practice-based clinical trials"(12:30-12:50)

    5. Martin Guppy - Metamols Medical Writing Agency- United Kingdom
    TITLE: "Transforming clinical data into compelling communication"(12:50-13:10))

  • 13:30-14:30 LUNCH BREAK

    Hotel Intercontinental
  • 14:30-16:30Session THREE - Oncology

    Moderator
    Conf. Dr. Diana Paun- - Presidential Advisor, Department of Public Health - Romania

    Moderator
    Dr. Marius Geanta - Director Center for Innovation in Medicine - Romania

    1. Dr. Marius Geanta, - Director Center for Innovation in Medicine, National Task Force Manager for Romania of the Public Health Genomics Network, Bucharest, Romania
    TITLE: "Value of data in oncology",(14:30-14:50)

    2. Dr. Daniel Radavoi - Primary Urologist, Urology Clinic - Hospital Clinic "Prof. Dr. Th. Burghele ", Bucharest, Romania
    TITLE: "Real life versus randomized clinical trials"(14:50-15:15)

    3. Prof. Dr. Orlin Savov - Director NameUrologie24 / EuromedClinic, Germany
    TITLE: "Management of Metastatic Castration - resistant Prostate Cancer (mCRPC) in the Era of Precision Oncology" (15:15-15:35)

    4. Dr. Ralph Wirtz - CEO&CSO at STRATIFYER Molecular Pathology GmbH Cologne Area, Germany
    TITLE: "Targeting the Host System - Immune Cell Infiltrates and Prediction of Tumor Response"(15:35-16:00)

    5. Dr. Raluca Van Staden - Director of Laboratory of Electrochemistry and PATLAB - Bucharest, Romania
    TITLE: "STOCµSENS-MD - a test for life"(16:00-16:25)
  • 16:30-16:45AFTERNOON COFFEE AND NETWORKING BREAK

  • 16:45-18:00VARIA Session

    16:45-17:50VARIA Session Moderator
    Dr. Calin Galaseanu -President of ARPIM , Country Manager Bristol Mayer & Squibb

    Moderator
    Dr. Catalina Sarbu - Country Manager Parexel Romania

    1. Panel of open discussions on "Regulatory approval process of clinical trials in Central Eastern Europe" (16:45-17:30)
    Participants:
    1. Dr. Alexandru Velicu - President of National Agency for Medicine and Medical Devices- Romania
    2. Prof. Dr. Constantin Mircioiu - Commission for Medical Ethics - Romania
    3. Conf. Dr. Svetlana Nichita - National Ethics Commission, Republic of Moldova
    4. Dr. Sergii Myronenko - PharmaSich CRO, Ukraine
    5. Dr. Ivan Georgiev- Head of Bulgarian Association of CROs, Bulgaria
    6. Pharm. Violeta Getova - Department of Pharmacovigilance and Clinical Trials, NDA Bulgaria
    7. Veska Gergova - Chief Legal Adviser of NDA, Bulgaria
    8. Pharm. Aleksandra Pesic - ACRP/CRA Academy, Serbia
    9. Baris Erdogan-Clinerion CRO, Head of EEMEA & Country Manager, Turkey
    10. Dr. Agnes Tamas Nemet- Head of Clinical Trial Authorization Division, Hungary

    2. GDPR's main implication on clinical studies and biobanking (17:30-17:45)
    Ioan Dumitrascu & Silviu Vasile - Pelifilip Business Law Company, Romania

    3. Mihai Manolache - Dr. PhD - PRESIDENT & CEO Cebis International Switzerland
    „The benefits of Patient’s Support Programs" (17:45-18:00)
  • 18:00-19:30RAFFLE & MUSICAL SOIREE

    Raluca Van Staden & Duo Van Staden (Piano Concert) ( 18:00-18:30)

    Brio Sonores (18:30-19:00 )

PARTENERI

REGISTRATION FORM / SYMPOSIUM FEES

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- between 10th of August - 30th September, registration is free of charge;


- between 1st October - 9th November, registration fee is LEI 500 + VAT 19% (about EURO 110 + VAT 19%), with 50% off for students;



FREE OF CHARGE REGISTRATIONS CAN NOT BE CHANGED WITH ANOTHER PERSON AFTER 1st OF OCTOBER

Supply of the above-mentioned data is mandatory for the conclusion of the symposium participation agreement. If you do not provide this data, you will not be able to attend the symposium.

The processing of he data is necessary for subscription to the symposium. We use your CNP Code only for confirmation of your participation with the organizations that award the participation credits for the symposium.

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You may ask any questions regarding the processing of your data to Mihaela Mateas, Assistant Manager, Company Representative, at mihaela.mateas@synevo.eu

Payment will be made to: Synevo Central Lab Clinical Trials Romania S.R.L., Industriilor 25 street, Comuna Chiajna, Ilfov. VAT No.: RO 30110226, J23/1113/2012, Bank Account: RO62INGB0001008199978910 (RON), ING Bank - Sucursala Bucuresti.


LECTORS / SPEAKERS

Cristina Florescu-Moraid, MD, MSc, EUSpLM - ORGANIZATOR EVENIMENT

Cristina Florescu-Moraid, MD, MSc, EUSpLM - EVENT ORGANIZER

Synevo Central Lab Country Director Romania, Republic of Moldova, Bulgaria & Serbia


„Cristina Florescu-Moraid este medic si conduce din anul 2005 divizia de operatiuni a companiei Synevo Central Lab din Romania, Republica Moldova, Bulgaria si Serbia. Traseul sau profesional include coordonarea a peste 180 de proiecte dintre care mai multe de 100 de studii clinice.
In 1997 absolva Universitatea de Medicina si Farmacie (UMF) „Carol Davila” din Bucuresti, devenind medic specialist in medicina de laborator in anul 2005 si medic primar in aceeasi specialitate in 2011.
Dintre multiplele cursuri si programe urmate de Cristina, pentru pregatirea sa ca manager se remarca masterul in management si sanatate publica obtinut in 2006 la UMF „Carol Davila” din Bucuresti, cursul postuniversitar de management al studiilor clinice de la Fundatia pentru Dezvoltare in Management Gdansk, Polonia, din anul 2012 si programul postuniversitar de dezvoltare si leadership absolvit in 2014 la Universitatea din Sussex, Marea Britanie.
Vasta sa experienta in industria de laborator si studii clinice depaseste 15 ani, astfel ca este deseori invitata ca lector la evenimente internationale de medicina de laborator si cercetare clinica. In plus, organizeaza cursuri si traininguri dedicate specialistilor din domeniul studiilor clinice.”

Adam Niels - Head of Laboratory Support Services, PSI CRO Deutschland GmbH, Germany

Adam Niels

Head of Laboratory Support Services, PSI CRO Deutschland GmbH, Germany


Dr. Adam Niels followed an embryological and neuroanatomic development research project at Rockefeller University in New York, USA. Currently, he is Head of Laboratory Support Services at PSI CRO GmbH, Munich, Germany. During his career he has held various positions, Senior Staff Scientist at Regeneron Pharmaceuticals, Tarrytown, NY, USA, Mouse Genetics Programme Manager, Wellcome Trust Sanger Institute, Cambridge, UK Head of Services and Development at MRC Harwell, Oxford, UK. Before taking up his current position, he was Senior Director of Science at Austrianni GmbH, Vienna, Austria.
Aleksandra Pesic - Pharm. ACRP/CRA Academy, Serbia

Pharm. Aleksandra Pesic

ACRP/CRA Academy, Serbia


Clinical Research Consultant. 20 years of experience in both pharmaceutical industry and contract research organizations. Registered pharmacist with a MSc in Pharmaceutical Medicine - Hibernia College Dublin Ireland and Harvard University, USA, post-graduate Diploma in Public Relations from the School of Economics - University of Belgrade, Serbia, post-graduate diploma in Medical Law from the Law School of University Union, Belgrade, Serbia, post-graduate Diploma in Cosmetic Science from the Society of Cosmetic Scientists, Luton, UK. Currently studying towards a PhD in Business Management and Leadership, Aston American University, USA. A Certified GCP Trainer ACRP and CRA Academy, IPMA Certified Senior Project Manager and FAcadTM - Fellowship of Academy of Translational Medicine Professionals - European Society for Translational Medicine, Vienna, Austria). GCP Auditor, a Member of RQA (The Research Quality Association, UK. Currently working as a Medical Writer, in Project Management, Compliance and Clinical Operations.
Alexandru Velicu - President of ANMMD Romania

Alexandru Velicu

President of ANMMD Romania


The President of the National Agency for Medicines and Medical Devices graduated the Faculty of Medicine and Pharmacy "Carol Davila", Bucharest, 2007. In 2011 he will graduate the Faculty of Financial Management at Spiru Haret University, Bucharest. From August 2017 he served as Vice President of NAMMD and since January 2018 he is the President of the National Agency for Medicines and Medical Devices.
Benedikt von Braunmühl- COO Medicover Diagnostics Services, Germany

Benedikt von Braunmühl

COO Medicover Diagnostics Services, Germany


Education
Benedikt von Braunmuhl has over 20 years of leadership experience in the diagnostic, life sciences, vaccines and pharmaceutical industry. He started his career as Management Trainee at ASTA Medica the former Degussa (now Evonik) Pharma Group. Following an assignment in the Brazilian o f ASTA Medica he held different positions in Investment Banking, Chiron, Novartis Vaccines & Diagnostics.In 2008 he joint QIAGEN as Head of Latin America to set up the regional headquarter in Sao Paulo, Brazil. Following the assignment in Brazil, he was appointed as General Manager Italy and moved on to take the responsibility for the Emerging Markets, particularly Eastern Europe, Russia, Africa, parts of Asia and Latin America. His last position at QIAGEN was Head of Global Commercial Operations and member of the Executive Committee. During the last two years, he consulted healthcare companies for strategic and geographic expansion projects, as well as financial investors during M&A activities in the diagnostic- and life science industry. Benedikt also serves as non-executive chairman of the board at PathoQuest, an innovative NGS focused Diagnostic company in France. He has a Bachelor in Business Administration from the Lorange Institute of Business in Zürich, is married, and has three daughters. He will relocate from Düsseldorf to, and be based at the office in Berlin.
Calin Galaseanu - President of ARPIM , Country Manager Bristol Mayer & Squibb

Calin Galaseanu

President of ARPIM , Country Manager Bristol Mayer & Squibb


Experienced Country General Manager with a demonstrated success history of working in the pharmaceutical industry accross Europe. Skilled in Performance Leadership, Marketing Management, Market Access, Pharmaceutics Sales, Oncology, Biotechnology and Change Management. Strong strategic and operations professional graduated from CEDEP - Executive Development – Fontainebleau. In present is President of ARPIM (Romanian Association of International Medicine Manufacturers), Country Manager Bristol-Myers Squibb.
Diana Paun - MD, Presidential Advisor - Department of Public Health Romania

Diana Paun - MD,

Presidential Advisor, Department of Public Health - Romania


Dr. Diana Loreta Paun (born 1968) is a graduate of the Faculty of Medicine and Doctor of Medicine at the "Carol Davila" University of Medicine and Pharmacy in Bucharest. She is a primary endocrinologist and associate professor at the Department of Endocrinology at the Carol Davila University of Medicine and Pharmacy. She worked at the National Institute of Endocrinology "C.I.Parhon" as a doctor, researcher, teacher, as a manager in 2006-20015. She holds a certificate of complementary studies in Health Services Management and has graduated the master's program "Public Health Management and Health Services". She also attended several management improvement programs, a quality auditor, a trainer and an expert in public procurement. Dr. Diana Loreta Paun is a member of national professional associations (Association of Clinical Endocrinology of Romania, Romanian Endocrinology Society) and international (German Endocrinology Society, European Society of Endocrinology (ESE)), member of the Romanian Association of AACE (American Association of Clinical Endocrinologists and his / her president from 2011 to 2012. She has published studies and scientific papers in nationally and internationally recognized specialty journals, as well as works in the field of health management and participated as a director or team member in scientific research projects national and international projects as well as in educational and continuing education projects. Dr. Diana Loreta Paun was appointed State Counselor on 1 June 2015. Dr. Diana Loreta Paun este membru în asociatii profesionale nationale (Asociatia de Endocrinologie Clinica din România, Societatea Româna de Endocrinologie) si internationale (Societatea Germana de Endocrinologie, Societatea Europeana de Endocrinologie (ESE), membru al Chapterului din Romania al AACE (American Association of Clinical Endocrinologists) si presedinte al acestuia în intervalul 2011-2012. A publicat studii si lucrari stiintifice în reviste de specialitate recunoscute national si international, precum si lucrari în domeniul managementului sanitar. A participat ca director sau membru al echipei în proiecte de cercetare stiintifica nationale si internationale precum si în proiecte educationale si de formare continua. Dr. Diana Loreta Paun a fost numita Consilier de Stat la data de 1 iunie 2015.
Dunja Rogic - MD, PhD - Clinical Institute of Laboratory Diagnostics, Clinical Hospital Center Zagreb, Croatia

Dunja Rogic

MD, PhD - Clinical Institute of Laboratory Diagnostics, Clinical Hospital Center Zagreb, Croatia


Prof Dunja Rogić, PhD is a medical biochemistry specialist which graduated in 1986 from School of Pharmacy and Biochemistry, University of Zagreb. In the 1986-1987 period had postgraduate study at School of Pharmacy and Biochemistry, University of Zagreb. She start worked at Laboratory for Endocrinology in 1987-1992 at University Hospital Center Zagreb. For the next three years she was a resident in laboratory medicine. For seven years (1995-2002) she was Head of General Clinical Chemistry Laboratory, University Hospital Center Zagreb. Won her PhD degree, and was awarded MBA degree - Leadership and Management in Health Services, Zagreb University School of Medicine and London School of Economics (2001-2003). In 2008 she was elected Assistant Professor at School of Pharmacy and Biochemistry, University of Zagreb, and since 2013 she has been Head of Department of Laboratory Diagnostics, University Hospital Center Zagreb, and Associate Professor at School of Pharmacy and Biochemistry, University of Zagreb. She has been an invited speaker/participant in many scientific meetings in Croatia and abroad, author and co-author of more than 50 scientific papers. Her fields of interest: evidence-based medicine, POCT, organization & management of clinical laboratory, laboratory parameters of renal diseases. She has been a lecturer and organizer of continuous education courses for physicians and medical biochemists, and editor/co-editor of several textbooks and author of book chapters. She is a member of EFLM Postanalytical WG right from the start, member of the National Health Council in Croatia, member of the Ethics Committee of the University Hospital Zagreb and President of the Professional Committee of the Croatian Chamber of Medical Biochemists. She is actively involved in undergraduate and graduate teaching at School of Pharmacy and Biochemistry, University of Zagreb, and School of Medicine, University of Zagreb.
Giuseppe Lippi - Prof. Dr. Full Professor of Clinical Biochemistry University of Verona

Prof. Dr. Giuseppe Lippi

Full Professor of Clinical Biochemistry University of Verona | UNIVR · Department of Neurological, Neuropsychological, Morphological and Movement Sciences, Italy


Giuseppe Lippi was born in Padova – Italy on October 4th, 1967. He became a Medical Doctor in 1992 and specialized in Clinical Biochemistry and Laboratory Medicine in 1996. He currently serves as Professor of Clinical Biochemistry and Molecular Biology at the University of Verona - Italy and Director of the Clinical Chemistry and Hematology laboratories of the University Hospital in Verona. He has participated to more than 500 national and international congresses and has given more than 250 lectures to national and international meetings. In 2017 he has been appointed as Secretary of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).. His main fields of research include pre-analytical variability, analytical and clinical validation of biomarkers, proteomics, diagnostics of the acute coronary syndrome, metabolism of lipoproteins and relevant assay methods, frailty, diagnosis and management of disorders of hemostasis.
Ioan Dumitrascu - Partner, Peli Filip, Romania

Ioan Dumitrascu

Partner, Peli Filip, Romania


Ioan is one of the founding partners of Peli-Filip and currently coordinates the Commercial Department of Peli-Filip, which gathers several practices, including Data protection practice area. He regularly advises companies on all aspects of data protection compliance, including data protection policies and procedures, the use of data in the provision of consumer and business products, Big Data issues, responding to data subject access requests, transfers of data in outsourcing projects and M&A transactions, cloud computing, data security breaches, cross border data transfers, transfers of data to overseas regulators, customer relationship management, employee monitoring and website compliance issues. Ioan has also assisted clients concluding successful deals in pharma, automotive, energy, retail, food & consumer goods, telecom, financial services or IT.
Janusz Kabata – MD, PhD, MBA, CEO GP4Research, Poland

Janusz Kabata

MD, PhD, MBA, CEO GP4Research, Poland


Janusz Kabata MD, PhD, MBA is a successful entrepreneurial healthcare professional with over 35 years of academic and executive experience in public and private healthcare sectors in Europe, and 25 years experience in various aspects of clinical trial management, including managing central laboratory services as well as home-care services for European and global clinical trials. He is co-founder of GP4research, which develops European GP Practice-Based Research Network. Prior to GP4research he co-founded GlobalCare Clinical Trials Ltd, and developed the network of home care service providers in Europe and Asia. He established Nova Medical Central Lab (now Synevo Central Lab). He is an expert in public health and laboratory medicine.
Julian Platon - MD, PhD - Head of Medical and Clinical Affairs, Luye Pharma, Switzerland

Dr. Med. Julian V. Platon

Head of Medical and Clinical Affairs, Luye Pharma, Switzerland


Dr. Julian V. Platon was 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 London, Cologne - Germany and Beer-Sheva - Israel. 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 held various 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 Development & Operations and Pharmacovigilance (incl. QPPV). Highlights of his professional life were Schwarz Pharma, Hoffmann-La Roche, Abbott, PharmaPart, Solvay and Alexion. Currently, Dr. Platon is Head of Medical & Clinical Affairs at Luye Pharma Europe. julian.platon@gmail.com
Marius Geanta, MD - CEO Center for Innovation in Medicine, Romania

Marius Geanta, MD

CEO Center for Innovation in Medicine, Romania


Co-fondator al Centrului pentru Inovație în Medicină National Task Force Manager pentru România al Public Health Genomics Network Expert pe medicină personalizată al European Development Platform Membru al European Alliance of Personalized Medicine Participant în proiectul IT Future of Medicine Fondator și director general al companiei de comunicare specializată medicală Kol Medical Media Redactor-sef al revistei Hipocrate, brand de referință pentru comunitatea medicală din România

Martin Guppy - Manchester University Medical School; Manchester - United Kingdom

Martin Guppy

Manchester University Medical School, United Kingdom


Martin Guppy has over 20 years’ experience as a writer, editor and creative in healthcare communications, including medical education, marketing, regulatory and digital. He has worked in many therapy areas but notably in oncology, infectious diseases, neurology, psychiatry, internal medicine, respiratory and cardiovascular medicine.Martin helps clients to deliver scientific manuscripts, promotional materials, mode of action communications, educational programmes, websites and digital tools, satellite symposia, speaker training materials, congress and advisory board reports, medical educational slide decks, and patient education resources.Martin has a BSc in Pharmacology and Psychology (University of Manchester, UK), an MSc in Toxicology (University of Birmingham, UK), a PhD in Molecular Oncology (University of Birmingham, UK), and post-doctoral research experience in cancer genetics at the Paterson Institute for Cancer Research (Manchester, UK).
Mihai Manolache, PhD – President & CEO – CEBIS International SAGL - Switzerland

Mihai Manolache, PhD

President & CEO – CEBIS International SAGL - Switzerland


Mihai Manolache is the founder of CEBIS International and he holds a PhD in Biostatistics and a Master's Degree in Biostatistics.  Mihai completed a Post-Graduate course in Immunology and Genetics at Harvard Medical School, Graduated from Law School, specializing in medical research laws and regulations, and graduated from Economics, specializing in Administrative Sciences, from the University of Bucharest.
Mihai has expertise in planning, managing and coordinating clinical studies globally.  He has directed more than 200 international clinical studies including managing research sites across Romania, Bulgaria, Croatia, Hungary, Serbia and Montenegro, Macedonia, Moldova, Greece, Turkey, India, Spain, Switzerland, Italy, Germany, Ukraine, Estonia, Latvia, and Lithuania. Mihai has managed clinical trials in a variety of therapeutic areas including cardiology, oncology, diabetes, CNS, hematology, urology, gastroenterology, pediatrics, HIV, immunology, ObGyn, respiratory, and dermatology.
Prior to the formation of CEBIS, Mihai was the Clinical Operations and Business Development Manager for a Global US-Michigan Based Contract Research Organization, responsible for setting up and developing clinical research business in the EMEA region. 
Mihai has published several papers and given more than 120 conference presentations in areas ranging from clinical research, clinical development, regulatory affairs, medical writing, biostatistics, project management, good clinical practices, ethics in research and risk management in research.
Mihai believes that more specialized needs around patient support will continue to grow around the world, especially in emerging markets. With a growth in new hi-tech therapies, patients require more customized options to solve their adherence needs, and pharmaceutical companies are changing how they address those needs.
Raluca Van Staden - Director of Laboratory of Electrochemistry and PATLAB - Bucharest, Romania

Raluca-Ioana van Staden

Director of National Institute of Research for Electrochemistry and Condensed Matter


Prof Dr Habil RALUCA-IOANA STEFAN-VAN STADEN is a Professor, Senior Researcher and Head of the Laboratory of Electrochemistry and PATLAB Bucharest, National Institute of Research for Electrochemistry and Condensed Matter, Romania. The author and co-author of more than 260 articles in ISI journals, especially in the fields of biomedical analysis, electrochemical sensors, process technology and flow systems, of three books: “Quality and reliability in analytical chemistry”, “Electrochemical Sensors in Bioanalysis” and “Laboratory Auditing for Quality and Regulatory Compliance” as well as of numerous chapters in other books, most of them related to sensors technology. Lately, she has developed new types of sensors for early detection of cancer, diabetes, hepatitis, for fast screening of cytokines, adipocytes, and seven neurotransmitters, and for the analysis of different substances of clinical interest in children’s saliva.
Ralph Wirtz - Dr. CEO&CSO at STRATIFYER Molecular Pathology GmbH Cologne Area, Germany

Dr. Ralph Wirtz

CEO&CSO at STRATIFYER Molecular Pathology GmbH Cologne Area, Germany


He studied at the University of Bonn in Germany, the doctoral thesis he held in Molecular Biology at the Max Delbrück Center for Molecular Medicine. Between 1995 and 2000, he worked as Scientific Assistant at the Max Delbrück Center for Molecular Medicine, then served as Principal Researcher and Head of Research Laboratory at Bayer HealthCare, and later at Siemens Healthcare Diagnostics. Beginning in September 2010 is CEO & CSO at STRATIFYER Molecular Pathology GmbH, Germany.
Sergii Myronenko - Dr. Clinical Trials Forum, Ucraina

Dr. Sergii Myronenko

Clinical Trials Forum, Ucraina


Clinical Research Professional with strong medical background: certified anesthesiologist. Has had work experience as ICU physician and Army Doctor, and practical experience in pharmaceutical industry since 2004 including clinical research, regulatory affairs and pharmacovigilance. Also the founder and managing Director of Pharmasich, a local Ukrainian CRO and consultancy for pharmaceutical industry. Member of the Extended Executive Board of European CRO Federation (EUCROF).Chairman of Kiev Clinical Research Forum, an international discussion platform for the clinical research industry based in Kiev, Ukraine. Professional interests: execution of clinical trials in Central & Eastern Europe; patient enrollment and site engagement strategies; models of collaboration between niche CROs and small to mid-size sponsors; strategies of development of innovative sectors in the biopharmaceutical industry. Websites: www.pharmasich.com; www.conference-pharmasich.com .
Silviu Vasile - Associate, Peli Filip, Romania

Silviu Vasile

Associate, Peli Filip, Romania


Silviu is part of PeliFilip's commercial department, which includes several areas of law, such as personal data protection, contracts, risk & compliance, labor law, new technologies, or energy and natural resources. Silviu is specialized in competition law and other regulatory issues and has significant experience in preparing contractual arrangements for various complex projects. Recent projects include the preparation of a new contractual structure and stipulations for clients in various industries, providing assistance in obtaining the necessary M&A authorizations in the pharma field, assisting in obtaining approvals from various regulators, drafting and reviewing contractual framework for clinical trials including cross-border counseling for the provisions of clinical trial services or the preparation of standard contracts and contractual structures for bio-banking specific activities, ranging from the supply to the use of biological samples.
Trefor Higgins - Director of Clinical Chemistry, Clinical Chemist, DynaLIFE, Clinical Professor, Department of Laboratory Medicine and Pathology University of Alberta, Canada

Prof. Dr. Trefor Higgins

University of Alberta Hospital in Edmonton Alberta, Canada


Trefor Higgins was born in the United Kingdom and studied at universities in the United Kingdom and Canada. He has worked for many years in medical laboratories’ in Edmonton, Canada. He has published over 200 articles and written several book chapters. He has received many awards for teaching and received the award for outstanding contribution to clinical chemistry from the Canadian Society of Clinical Chemistry. He has served on several local, national and international committees and is currently a member of the International Federation of Clinical Chemistry Task Force on Medical Ethics and the Canadian Taskforce on harmonized reference intervals.. His primary interest is hbA1c and hemoglobinopathies. Currently he is zone director of Medical Biochemistry for the Edmonton Zone in Alberta covering 9 hospitals.

PARTENERS

LOCATION

Hotel Intercontinental