CLINICAL TRIALS SYMPOSIUM Reshaping the clinical research landscape as consequence of latest geopolitical challenges NOVEMBER 18, 2022 - HYBRID EVENT

AGENDA

18th of November, 2022 – 1 day hybrid event Hanul cu tei, Bucharest & Online

“Reshaping the clinical research landscape as consequence of latest geopolitical challenges”
Wide opportunities for CEE to boost presence in international clinical trials



  • (8:30-9:00 Central Eastern Time CET)
    Registration and welcome coffee
    09:30 10:00
  • (9:00-9:15 Central Eastern Time CET)
    Welcome speeches
    Dr. Cristina Florescu Moraid, organizer - President of Clinical Trials Symposium (Romania)
    Message from the Presidential Counselor Romanian Administration
    Presented by Assoc. Prof. Dr. Diana Paun - Presidential Counselor Romanian Administration
    Message from European CRO Federation
    Dr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF)
    In memoriam Prof. Univ.Dr. Constantin Mircioiu
    10:00 10:15
  • (9:15-10:00 Central Eastern Time CET)
    Implementation of the new EU legislation for clinical trials (No 536/2014) in Romania: status quo and open actions
    Chair:
    Dr. George Regio Tanaseanu, President of the Romanian Association of CROs (ACCSCR) Romania, CEO PSI Pharma Romania
    Speakers:
    Dr. Pharm. Razvan Mihai Prisada, President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR)
    Prof. Dr. Doina Draganescu, President of the Ethics Commission, National Bioethics Commission of Medicines and Medical Devices, Romania, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Romania
    Prof. Dr. Viorel Jinga, Rector at the “Carol Davila” Medicine and Pharmacy University Bucharest, Romania
    Prof. Dr. Adrian Streinu Cercel, President of the Health Commission of the Senate, Romanian Parliament, Romania
    Assoc. Prof. Dr. Michael Schenker, President of Oncology Comission, Ministry of Health, The founder and manager of “Saint Nectarie” Oncology Center, Romania
    Dr. Catalina Sarbu, Secretary General of the Romanian Association of CROs (ACCSCR) Romania
    Pharm. Mihaela David, Director of Regulatory Affairs - PSI Pharma Support Romania
    10:15 11:00
  • (10:00-10:30 CET)
    Coffee Break
    11:00 11:30
  • (10:30-11:00 Central Eastern Time CET)
    The impact of the war in Ukraine on Clinical trials. Status quo and opportunities
    Dr. Sergii Rasputniak, State Expert Center of the Ministry of Health, Ukraine, Head of Laboratory and Clinical Practices (GLP, GCP) Audit Office
    Dr. Evgeny Levenko, Country Manager ARENSIA Exploratory Medicine, Ukraine
    11:30 12:00
  • (11:00-11:30 Central Eastern Time CET)
    Opportunities and challenges for Romania and its neighbours to boost contribution to international clinical trials in context of local geopolitics-panel discussion
    Chair:
    Dr. Catalina Sarbu, Secretary General of the Romanian Association of CROs (ACCSCR) Romania
    Speakers:
    Dr. Adriana Vasilache, Director Clinical Operations at IQVIA, Romania
    Vlad Croitoru, Senior Manager, Clinical Operations, PAREXEL Country Head Romania & Moldova
    Dr. Yuri Titov, Country Director PSI CRO Hungary
    Dr. Lucia Turcan, Associate professor at The State University of Medicine and Pharmacy “Nicolae Testemitanu”, Chisinau, Moldova, the Pharmacology and Clinical Pharmacology departament , vice-president of the National committee for the ethical expertise of the clinical study, RM
    12:00 12:30
  • (11:30-12:30 CET)
    Lunch
    12:30 13:30
  • (12:30-13:00 Central Eastern Time CET)
    Innovative Trial Designs in early phase clinical development: operational challenges and best practices
    Dr. Med. Eugenia Prohin, Manager International Clinical Operation, ARENSIA Exploratory Medicine Germany
    13:30 14:00
  • (13:00-13:30 Central Eastern Time CET)
    Decentralized and Hybrid Clinical Trials in EU: Regulatory environment and readiness among healthcare professionals and sponsors to implement these
    Muirinn Cullenn, Director Operations, Decentralised Clinical Trial Solutions, ICON Ireland
    Stacey Fergursson, PhD, Director of Corporate Development, Illingworth Research Group™, United Kingdom
    14:00 14:30
  • (13:30-14:00 Central Eastern Time CET)
    Digitization of clinical research: status-quo and case studies from real life experiences
    Florin Petrutiu, CIO/CISOCIO/CISO, CNS Healthcare, USA
    14:30 15:00
  • (14:00-14:30 CET)
    Coffee Break
    15:00 15:30
  • (14:30-15:00 Central Eastern Time CET)
    Learning and take aways after 2 years of clinical research in the pandemic environment: patient enrolment and retention, site performance and monitoring activities
    Jennifer Teti, Senior Director, Clinical Research at IMV Inc. (Dartmouth, Nova Scotia, Canada)
    15:30 16:00
  • (15:00-15:30 Central Eastern Time CET)
    Importance of patient´s voice in clinical research: view from patient associations
    Moderator:
    Rozalina Lapadatu, President of Autoimmune Disease Patients Association, Romania
    Speakers:
    Alina Comanescu, Founder of Community Health Association, Romania
    Radu Ganescu, President of the Coalition of Organizations of Patients with Chronic Diseases (COPAC) Romania
    Marinela Debu, President of Hepatic Disease Patient Association, Romania
    Cezar Irimia, President of Chronic Disease Patient Association, Romania (FABC)
    Prof. Dr. Cristina Stefan, Director of The Institute of Global Health Equity Research, Romania
    16:00 16:30
  • (15:30-15:45 Central Eastern Time CET)
    Conclusions
    Dr. Cristina Florescu Moraid, CEO Avantyo Institute of Clinical Research
    16:30 16:45
  • (15:45-16:30 Central Eastern Time CET)
    Musical Soiree
    Alessandro Mucea
    16:45 17:30


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SPEAKERS

Assoc. Prof. Dr. Diana Paun Assoc. Prof. Dr. Diana Paun Romanian Presidential Administration
Prof. Dr. Viorel Jinga Prof. Dr. Viorel Jinga Rector at the “Carol Davila” Medicine and Pharmacy University Bucharest, Romania
Prof. Dr. Doina Draganescu Prof. Dr. Doina Draganescu President of the Ethics Commission, National Bioethics Commission of Medicines and Medical Devices, Romania, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Romania
Dr. Pharm. Razvan Mihai Prisada Dr. Pharm. Razvan Mihai Prisada President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR)
Prof. Dr. Adrian Streinu Cercel Prof. Dr. Adrian Streinu Cercel President of the Health Commission of the Senate, Romanian Parliament
Dr. Martine Dehlinger Kremer Dr. Martine Dehlinger Kremer President of European CRO Federation (EUCROF);
VP Scientific Affairs, Paediatric SME, ICON
Assoc. Prof. Dr. Michael Schenker  Assoc. Prof. Dr. Michael Schenker  President of Oncology Comission, Ministry of Health, The founder and manager of “Saint Nectarie” Oncology Center, Romania
Dr. Sergii Rasputniak Dr. Sergii Rasputniak State Expert Center of the Ministry of Health, Ukraine, Head of Laboratory and Clinical Practices (GLP, GCP) Audit Office
Dr. George Regio Tanaseanu Dr. George Regio Tanaseanu President of the Romanian Association of CROs (ACCSCR) Romania
Country Manager PSI CRO AG Romania
Dr. Catalina Sarbu Dr. Catalina Sarbu Secretary General of the Romanian Association of CROs (ACCSCR) Romania
Dr. Adriana Vasilache Dr. Adriana Vasilache Director Clinical Operations at IQVIA, Romania
Dr. Med. Eugenia Prohin Dr. Med. Eugenia Prohin Manager International Clinical Operation, ARENSIA Exploratory Medicine Germany
Vlad Croitoru Vlad Croitoru Senior Manager Clinical Operations, PAREXEL
Country Head Romania & Moldova
Dr. Yuri Titov Dr. Yuri Titov Country Director PSI CRO Hungary
Dr. Lucia Turcan Dr. Lucia Turcan Associate professor at The State University of Medicine and Pharmacy “Nicolae Testemitanu”, Chisinau, Moldova, the Pharmacology and Clinical Pharmacology departament , vice-president of the National committee for the ethical expertise of the clinical study, RM
Dr. Evgeny Levenko Dr. Evgeny Levenko Country Manager ARENSIA Exploratory Medicine, Ukraine
Florin M. Petrutiu, MIT, CISSP Florin M. Petrutiu, MIT, CISSP CIO/CISOCIO/CISO, CNS Healthcare, USA
Rozalina Lapadatu Rozalina Lapadatu President of Autoimmune Disease Patients Association, Romania
Muirinn Cullen Muirinn Cullen Director Operations, Decentralized Clinical Trial Solutions, ICON Ireland
PhD Stacey Fergursson PhD Stacey Fergursson Director of Corporate Development, Illingworth Research Group™, United Kingdom
Alina Comanescu Alina Comanescu Founder of Community Health Association, Romania
Radu Ganescu Radu Ganescu The president of the Coalition of Organizations of Patients with Chronic Diseases (COPAC), Romania
Marinela Debu Marinela Debu President of Hepatic Disease Patient Association, Romania
Cezar Irimia Cezar Irimia President of Chronic Disease Patient Association (FABC), Romania
Pharm. Mihaela David Pharm. Mihaela David Director of Regulatory Affairs - PSI Pharma Support Romania
Jennifer Teti Jennifer Teti Senior Director, Clinical Research
IMV Inc. (Dartmouth, Nova Scotia, Canada)
Prof. Dr. Cristina Stefan Prof. Dr. Cristina Stefan Director of The Institute of Global Health Equity Research, Romania
Dr. Cristina Florescu Moraid, MSc, EuSpLM, MRQA Dr. Cristina Florescu Moraid, MSc, EuSpLM, MRQA President of Clinical Trials Symposium
CEO AVANTYO Institute of Clinical Research

CONTACT

For more information about your participation, please contact us at info@clinicaltrialsymposium.com

For additional information regarding partnership, sponsors & exhibitors and media, please contact our marketing and communication department
at diana.lupu@avantyo.com or +40 (0) 726 840 456

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Clinical Trials Symposium is an event organized by Avantyo Institute of Clinical Research - www.avantyo.com