CLINICAL TRIALS SYMPOSIUM Accelerating Patient Access to Novel Medications:
Navigating the Regulatory, Scientific and Operational Challenges in Clinical Trials OCTOBER 11, 2019 - BUCHAREST, ROMANIA

AGENDA

Final Draft
  • Registration and Welcome Coffee
    08:00 09:00
  • Welcome Speech
    Dr. Cristina Florescu Moraid, organizer - President of Clinical Trials Symposium
    09:00 09:10
  • Importance of Developing Clinical Trials in the Medical Community
    Message from Romanian President Administration presented by Assoc. Prof. Dr. Diana Paun – State Advisor of the Romanian President, Romania
    09:10 09:20
  • Clinical Trials - Real Benefit for Patients and Physicians
    Prof. Dr. Catalina Poiana – “C.I. Parhon” Institute of Endocrinology, “Carol Davila” University of Medicine and Pharmacy, President of Physicians’ College of Bucharest, Romania
    09:20 09:30
  • General Presentation of European CRO Federation activity
    Dr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF); Vice President Pediatric Development, Synteract, Germany
    09:30 09:45

Outsourcing in Clinical Trials

Scientific Session

CHAIRS:
Dr. Cristina Florescu Moraid, Organizer - President of Clinical Trials Symposium, CEO AVANTYO Institute of Clinical Research, Romania
Dr. Camelia Grigore – Manager of Clinical Paediatric Hospital of Sibiu, Romania

  • Overview on Laboratory Errors and Potential Implications for Clinical Trials
    Prof. Dr. Giuseppe Lippi – Professor of Clinical Biochemistry, Director Laboratory of Clinical Chemistry and Hematology, University Hospital of Verona, Italy
    09:45 10:05
  • Pre- and Postanalytical Cause of Laboratory Errors
    Assoc. Prof. Dr. Gian Luca Salvagno – Assoc. Prof. of Clinical Biochemistry - Department of Neurological, Biomedical and Movement Sciences, University of Verona, Italy
    10:05 10:30
  • GDP and Regulatory Compliance – Current Developments and Challenges for the Pharmaceutical Supply Chain
    Michael Fleischer - Global Quality Director, World Courier, Germany
    10:30 10:50
  • Building up the New Leadership in Clinical Trials
    Dr. Cristina Florescu Moraid, organizer - President of Clinical Trials Symposium, CEO AVANTYO Institute of Clinical Research, Romania
    10:50 11:00

Break & networking

  • Coffee break and exhibition networking
    11:00 11:30

Regulatory Affairs, Quality Assurance & Compliance

Scientific Session

CHAIRS:
Dr. Catalina Sarbu - Director Clinical Operations Parexel International Romania, Head of the CRO Association in Romania (ACCSCR)
Dr. Calin Galaseanu - General Manager Novo Nordisk Hungaria Kft, Hungary

  • Regulatory Landscape in Europe in View of Implementing the New Regulation for Harmonized Submission
    Dr. Barbara Schug - Managing partner at SocraTec R & D GmbH, Germany
    11:30 11:50
  • How are the New Privacy Regulation in EU Impacting on Efficient Conduct of Clinical Trials
    Attorn. Ioan Dumitrascu, Attorn. Diana Gavra - Filip & Company law firm, Romania
    11:50 12:10
  • Preparation for FDA & EMA Inspections: Practical Insights for CRO /Site Perspective
    Dr. Pia Nutt - Director Quality Assurance & Compliance, ARENSIA Exploratory Medicine GmbH, Germany
    12:10 12:30
  • Panel Discussion – Similarities & Differences in the Approval Process of Clinical Trials across Various European Countries
    Moderators: Dr. Catalina Sarbu - Director Clinical Operations Parexel International Romania, Head of the CRO Association in Romania (ACCSCR), Romania
    Dr. Calin Galaseanu - General Manager Novo Nordisk Hungaria Kft, Hungary
    Panelists: Romanian Drug Agency representative
    Acad. Prof. Dr. Constantin Mircioiu - Secretary of the National Ethics Commission, Romania
    Ada Alexandra Georgescu - Personal Advisor to the Secretary of State Dr. Dan Octavian Alexandrescu at the Romanian Health Ministry, Romania
    Senator Dr. Emanuel Botnariu - Member of Health Commission, Romanian Senate – The Parliament of Romania
    Assoc. Prof. Svetlana Nichita - National Ethics Commission, Republic of Moldova
    Dr. Leyla Amrahova - Associated Professor, Internal Medicine Department of Azerbaijan Medical University
    Dr. Sergii Rasputniak - Head of Laboratory and Clinical Practices (GLP, GCP) Audit Office at the State Expert Center of the Ministry of Health, Ukraine
    Dr. Tine Laethem - Executive Director, Head Early Stage Development, Merck Sharpe & Dohme, Brussels, Belgium
    Dr. Barbara Schug - Managing partner at SocraTec R & D GmbH, Germany
    Dr. Pia Nutt - Director Quality Assurance & Compliance, Arensia Exploratory Medicine, Germany
    Sorin Petcu - General Manager IQVIA, Romania
    Dr. Bogdana Mitea - Clinical Research Manager/Local Quality&Compliance Manager, Global Clinical Operations Romania, Johnson & Johnson Romania SRL, Romania
    12:30 13:30

Break & networking

  • Lunch break and exhibition networking
    13:30 14:30

Site Solution and Patient Centricity

Scientific Session

CHAIRS:
Assoc. Prof. Dr. Diana Paun – State Advisor of the Romanian President, Romania
Dr. Marius Geanta – Co-Founder & President at Center for Innovation in Medicine, Romania

  • Lessons to be learned for an efficient execution of a clinical trial protocol with a multi-country, multi-center set-up
    Prof. Dr. Sergey Kozhukhov - Head of Clinical Pharmacology and Cardio-Oncology Unit, “NSC M.D.Strazhesko”Institute of Cardiology, Ukraine
    14:30 14:50
  • Cancer plan: data, technology and human touch
    Dr. Marius Geanta - Co-Founder & President at Center for Innovation in Medicine, Romania
    14:50 15:10
  • Accessing clinical trial from patient's perspective
    Gabriel Buiculescu – Patient advocate, Romanian Melanoma Association
    15:10 15:30
  • Panel Discussion: Roadblocks in Patient Enrolment
    Moderators: Dr. George Tanaseanu - Country Manager PSI CRO AG, Romania
    Rozalina Lapadatu - President of Autoimmune Disease Patients Association
    Panelists: Prof. Dr. Viorel Jinga – Head of Urology Department at „Prof. Dr. Th. Burghele” Clinic Hospital Bucharest; Professor at the “Carol Davila” Medicine and Pharmacy University Bucharest, Romania
    Prof. Dr. Dan Gaita - Institute of Cardiovascular Diseases, Timisoara, Romania
    Prof. Dr. Catalina Poiana – “C.I. Parhon” Institute of Endocrinology, “Carol Davila” University of Medicine and Pharmacy, President of Physicians’ College of Bucharest, Romania
    Dr. Florin Radulescu – CEO Duo Medical, Bucharest, Romania
    Dr. Laurentiu Micu - Fundeni Clinical Institute Romania, Romanian Association for the Study of Liver, Romania
    Alina Comanescu - Founder of Patient Association “Community Health Romania”, Romania
    Lucica Nitu - President of Patient Association “S.O.S. Myelom”, Romania
    15:30 16:15

Break & networking

  • Coffee break and exhibition networking
    16:15 16:30

Clinical Development and Operations Session

Scientific Session

CHAIRS:
Dr. Julian V. Platon - Platon Strategies & Operations - R&D and MA Consulting, Basel, Switzerland
Dr. Martine Dehlinger Kremer - Vicepresident Pediatric Development, Synteract Germany

  • Changes in the Drug Development Landscape: Pediatric Development is no longer an Option
    Dr. Martine Dehlinger Kremer - Vice President Pediatric Development, Synteract, Germany; President of European CRO Federation (EUCROF)
    16:30 16:50
  • Clinical Research Profile in Emerging MEA Countries: Regulatory, Operational & Logistic aspects
    Nadia Cheaib – Chairwoman Clingroup, President Health Committee French Chamber Egypt, President Hope MCF, Lebanon
    16:50 17:10
  • Challenges, Novel Designs and Future Visions in Early Phase Clinical Trials
    Dr. Angela Bischoff - Director Clinical Operations, ARENSIA Exploratory Medicine GmbH Germany
    17:10 17:30
  • Panel Discussion – Cooperation between Medical Affairs, Clinical Development and Clinical Operations
    Moderators: Dr. Julian V. Platon - Platon Strategies & Operations - R&D and MA Consulting, Basel, Switzerland
    Dr. Claudia Hesselmann - CEO ARENSIA Exploratory Medicine GmbH, Germany
    Panelists: Dr. Florina Prundaru - Clinical Research Manager Romania and Bulgaria, MSD Romania
    Dr. Lucio Fumi - CEO of Wyfold Medical, United Kingdom
    Aleksandra Pesic – President of CRA Academy, Serbia
    Daniela Pirvu - Clinical Research Associate, CTG Cardiomed Romania
    Dr. Cristian Benza - Medical Affairs Director, Janssen Romania
    17:30 18:15

Prizes and remarks

  • Tombola and Closing Remarks
    Dr. Cristina Florescu Moraid, organizer – President of Clinical Trials Symposium, CEO AVANTYO Institute of Clinical Research, Romania
    18:15 18:30

Social Session

  • Social - Networking drinks and musical soiree
    18:30 19:30


Register now

SPEAKERS

Assoc. Prof. Leyla Amrahova Assoc. Prof. Leyla Amrahova Associated Professor, Internal Medicine Department of Azerbaijan Medical University Dr. Cristian Benza Dr. Cristian Benza Medical Affairs Director, Janssen Romania Dr. Angela Bischoff Dr. Angela Bischoff Director Clinical Operations, ARENSIA Exploratory Medicine GmbH, Düsseldorf, Germany Senator Dr. Emanuel Gabriel Botnariu Senator Dr. Emanuel Gabriel Botnariu Member of Health Commission, Romanian Senate – The Parliament of Romania Gabriel Buiculescu Gabriel Buiculescu E-patient Dr. Nadia Cheaib Dr. Nadia Cheaib Chairwoman Clingroup, President Health Committee French Chamber Egypt, President Hope MCF, Lebanon Alina Comanescu Alina Comanescu Founder of Patient Association “Community Health Romania” Ioan Dumitrascu Ioan Dumitrascu Associate Filip & Company law firm, Romania Michael Fleischer Michael Fleischer Global Quality Director, World Courier, Germany Dr. Cristina Florescu Moraid Dr. Cristina Florescu Moraid Organizer - President of Clinical Trials Symposium, CEO AVANTYO Institute of Clinical Research, Romania Dr. Lucio Fumi Dr. Lucio Fumi CEO of Wyfold Medical, United Kingdom Prof. Dr. Dan Gaita Prof. Dr. Dan Gaita Institute of Cardiovascular Diseases, “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania Dr. Calin Galaseanu Dr. Calin Galaseanu General Manager Novo Nordisk Hungaria Kft, Hungary Diana Gavra Diana Gavra Associate Filip & Company Dr. Marius Geanta Dr. Marius Geanta Co-Founder & President at Center for Innovation in Medicine Ada Alexandra Georgescu Ada Alexandra Georgescu Personal Advisor to the Secretary of State Dr. Dan Octavian Alexandrescu at the Romanian Health Ministry, Romania Dr. Camelia Grigore Dr. Camelia Grigore Manager of Clinical Paediatric Hospital of Sibiu, Romania Dr. Claudia Hesselmann Dr. Claudia Hesselmann CEO ARENSIA Exploratory Medicine GmbH, Germany Prof. Dr. Viorel Jinga Prof. Dr. Viorel Jinga Head of Urology Department at „Prof. Dr. Th. Burghele” Clinic Hospital Bucharest; Professor at the “Carol Davila” Medicine and Pharmacy University Bucharest, Romania Prof. Dr. Sergey Kozhukhov Prof. Dr. Sergey Kozhukhov Head of Clinical Pharmacology Department & Cardio-Oncology Unit, NSC M. D. Strazhesko Institute of Cardiology, Ukraine Dr. Martine Dehlinger Kremer Dr. Martine Dehlinger Kremer Vicepresident Pediatric Development, Synteract Germany Tine Laethem Tine Laethem Executive Director, Head Early Stage Development, Merck Sharpe & Dohme, Brussels, Belgium Rozalina Lapadatu Rozalina Lapadatu President of Autoimmune Disease Patients Association Prof. Dr. Giuseppe Lippi Prof. Dr. Giuseppe Lippi Full Professor of Clinical Biochemistry University of Verona, Director of Laboratory of Clinical Chemistry and Hematology at the University Hospital of Verona – Italy Dr. Laurentiu Micu Dr. Laurentiu Micu Fundeni Clinical Institute Romania, Romanian Association for the Study of Liver, Romania Acad. Prof. Dr. Constantin Mircioiu Acad. Prof. Dr. Constantin Mircioiu President of Pharmaceutical Dept. Academy of Medical Sciences Vice-President of National Commission of Bioethics of Drugs and Medical Devices Dr. Bogdana Mitea Dr. Bogdana Mitea Clinical Research Manager/Local Quality&Compliance Manager, Global Clinical Operations Romania, Johnson & Johnson Romania SRL, Romania Assoc. Prof. Dr. Svetlana Nichita Assoc. Prof. Dr. Svetlana Nichita National Ethics Commission, Republic of Moldova Lucica Nitu Lucica Nitu President of Patient Association “S.O.S. Myelom”, Romania Dr. Pia Nutt Dr. Pia Nutt Director Corporate Quality Assurance & Compliance, ARENSIA Exploratory Medicine GmbH, Düsseldorf, Germany Assoc. Prof. Dr. Diana Paun Assoc. Prof. Dr. Diana Paun State Advisor of the Romanian President, Romania Aleksandra Pesic Aleksandra Pesic President of CRA Academy, Serbia Sorin Petcu Sorin Petcu General Manager IQVIA, Romania Daniela Pirvu Daniela Pirvu Clinical Research Associate, CTG Cardiomed Romania Dr. Julian V Platon Dr. Julian V Platon Platon Strategies & Operations - R&D and MA Consulting, Basel, Switzerland Prof. Dr. Catalina Poiana Prof. Dr. Catalina Poiana “C.I. Parhon” Institute of Endocrinology, “Carol Davila” University of Medicine and Pharmacy, President of Physicians’ College of Bucharest, Romania Dr. Florina Prundaru Dr. Florina Prundaru Clinical Research Manager Romania and Bulgaria, MSD Romania Dr. Florin Radulescu Dr. Florin Radulescu CEO Duo Medical, Rheumatology MD, Bucharest, Romania Dr. Sergii Rasputniak Dr. Sergii Rasputniak Head of Laboratory and Clinical Practices (GLP, GCP) Audit Office at the State Expert Center of the Ministry of Health, Ukraine Prof. Gian Luca Salvagno, MD, PhD Prof. Gian Luca Salvagno, MD, PhD Associate Professor of Clinical Biochemistry Section of Clinical Biochemistry Department of Neurological, Biomedical and Movement Sciences University of Verona Dr. Catalina Sarbu Dr. Catalina Sarbu Director Clinical Operations Parexel International Romania, Head of the CRO Association in Romania (ACCSCR), Romania Dr. Barbara Schug Dr. Barbara Schug Managing partner SocraTec R & D GmbH, Past President of German Association for Applied Human Pharmacology, Germany Dr. George Tanaseanu Dr. George Tanaseanu Country Manager PSI CRO AG, Romania

VENUE

Intercontinental Hotel - Nicolae Bălcescu Boulevard 4, Bucharest, 010051

ACCOMODATION

Book directly and benefit from the special discounted rates available for the participants at the Clinical Trials Symposium!

Contact Ruxandra Cernat at cernat.ruxandra@ihg.com or +40 729 038 943

CONTACT

For more information about your participation, please contact us at info@clinicaltrialsymposium.com or call us at +40 (0) 721 884 421

For additional information regarding partnership, sponsors & exhibitors and media, please contact our
marketing and communication department at anca.bejenaru@clinicaltrialsymposium.com or +40 (0) 726 840 456 +40 (0) 742 231 001

STAY CONNECTED

Subscribe to our newsletter and stay connected to news about
our symposium and AVANTYO Institute of Clinical Research!