AGENDA

19th of November, 2021 – 1 day virtual event
  • (8:30-9:00 Central Eastern Time CET)
    Registration on the website
    09:30 10:00
  • (9:00-9:30 CET)
    Welcome Speech
    Dr. Cristina Florescu Moraid, organizer - President of Clinical Trials Symposium (Romania)
    Message from the Presidential Administration of Romania
    Presented by Assoc. Prof. Dr. Diana Paun - Presidential Advisor
    Message from European CRO Federation
    Dr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF)
    10:00 10:30
  • (9:30-10:30 CET)
    Regulatory environment of developing clinical trials in Romania – Panel Discussion
    Chair:
    Dr. Cristina Florescu Moraid, Director Avantyo Institute of Clinical Research
    Speakers:
    Prof.Dr.Robert Ancuceanu, President of Romanian National Agency for Drugs and Medical Devices Romania(NADMD)
    Prof. Dr. Doina Draganescu, National Bioethics Commission of Medicines and Medical Devices, Romania, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy
    Assoc. Prof. Dr. Diana Paun - Presidential Advisor
    Prof. Dr. Viorel Jinga, Rector “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
    Prof.Dr.Adrian Streinu Cercel, President of the Health Commission of the Senate, Romanian Parliament
    Pharm. Monica Negovan, Director of Pharmaceutical and Medical Devices, Ministry of Health - Romania
    Dr. Catalina Sarbu – Head of the CRO Association in Romania (ASSCRC), Director Clinical Operations Parexel International Romania
    Dan Zaharescu, The executive director of the Romanian Association of International Drug Manufacturers
    Assoc. Prof. Dr. Michael Schenker, President of Oncology Comission, Ministry of Health, The founder and manager of “Saint Nectarie” Oncology Center, Romania
    10:30 11:30
  • (10:30-11:00 CET)
    Break
    11:30 12:00
  • (11:00-11:30 CET)
    Innovative therapies in prevention and treatment of COVID-19
    Tatiana Eidus – Director Corporate Development, ARENSIA Exploratory Medicine Inc. Boston, MA, USA
    12:00 12:30
  • (11:30-12:30 CET)
    View on global COVID-19 vaccination status; status-quo Romania
    Chair:
    Dr. Marius Geanta – President and Co-Founder of Innomed- Center for Innovation in Medicine, Romania
    Speakers:
    Sibilia Quilici, Executive Director Vaccines Europe, European Federation of Pharmaceutical Industries and Associations (EFPIA)
    H.E.Mr. David Saranga, The Ambassador Of the State of Israel to Romania
    Assist.Prof.Col.Dr.Valeriu Gheorghita, President of Vaccination Campaign Romania
    Dr.Lucio Fumi - CEO Piramal Enterprises, United Kingdom
    Assoc.Prof.Dr.Simin Aysel Florescu - General Manager “Victor Babes” Hospital, Bucharest, Romania
    Dr.Radu Ciprian Tincu - Coordinator Intensive Care Department, “Floreasca” University Hospital, Bucharest, Romania
    Dr.Sandra Alexiu - President of Family Physician Association, Bucharest, Romania
    12:30 13:30
  • (12:30-13:30 CET)
    Lunch Break
    13:30 14:30
  • (13:30-14:15 CET)
    Harmonization of Clinical Trials in EU. Latest Updates Related Implementation of CTR 536/2014; Status Quo Romania and CEE countries
    Chair:
    Pharm. Mihaela David - Director of Regulatory Affairs - PSI Pharma Support CRO AG, Romania
    Speakers:
    Prof.Dr.Robert Ancuceanu, President of Romanian National Agency for Drugs and Medical Devices Romania(NADMD)
    Prof. Dr. Doina Draganescu, National Bioethics Commission of Medicines and Medical Devices, Romania, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy
    Dr. Anna Chioti MD, MPH, MBA, Head of Division Pharmacy and Medicines at Luxembourg Health Directorate, Luxembourg
    Pharm. Lene Grejs Petersen, Senior Adviser, Clinical Trials, Danish Medicines Agency, Denmark
    Dr. Stefan Strasser, Head of Clinical Trials, Institute Surveillance, Austria
    Dr. Dagmar Chase, BPI Senior Expert, CEO of Clinrex Munich, Germany
    Katarina Kovacova, Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, Slovakia
    14:30 15:15
  • (14:15-15:50 CET)
    Deep dive into decentralized clinical trials - Panel Discussion
    Chair:
    Dr.Donato Bonifazzi - CEO Consorzio per Valutazioni Biologoche e Farmacologiche (CVBF) Italy
    Speakers:
    Dr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF); VP Scientific Affairs, Paediatric SME, ICON
    Mirjam Bruggink - Managing Director Clinical Trials Service, The Netherlands
    Dr. Aleksandra Pesic - President of CRA Academy, Serbia
    Dr. Janusz Kabata - MBA, PhD-CEO GP4Research, Poland
    Dr. Cristina Florescu Moraid, Director Avantyo Institute of Clinical Research
    15:15 15:50
  • (14:50-15:00 CET)
    AvantYOU - launching Health & Technology Premium Review-published by Avantyo Institute of Clinical Research
    Alexandra Manaila - Medical Journalist
    Dr. Cristina Florescu Moraid - Director Avantyo Institute of Clinical Research
    15:50 16:00
  • (15:00-15:15 CET)
    Break
    16:00 16:15
  • (15:15-15:50 CET)
    Patient Access to Clinical Trials – Panel Discussion
    Moderator:
    Rozalina Lapadatu, President of Autoimmune Disease Patients Association, Romania
    Speakers:
    Pharm. Dipl. Árpád Kiss – Director Global Clinical Operations Janssen, Hungary & Romania
    Dr.Sandra Alexiu - President of Family Physician Association, Bucharest, Romania
    Alina Comanescu - Founder of Community Health Association, Romania
    Radu Ganescu - The president of the Coalition of Organizations of Patients with Chronic Diseases in Romania
    Dr. Ioana Bianchi - External Affairs Director, Romanian Association of Drug Manufacturers and Improrters - ARPIM
    Marinela Debu - President of Hepatic Disease Patient Association, Romania
    16:15 16:50
  • (15:50-16:00 CET)
    CLOSING REMARKS
    16:50 17:00


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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 and andrei.grigore@avantyo.com or +40 (0) 728 453 248

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