AGENDA
19th of November, 2021 – 1 day virtual event-
(8:30-9:00 Central Eastern Time CET)Registration on the website
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(9:00-9:30 CET)Welcome SpeechDr. Cristina Florescu Moraid, organizer - President of Clinical Trials Symposium (Romania)Message from the Presidential Administration of RomaniaPresented by Assoc. Prof. Dr. Diana Paun - Presidential AdvisorMessage from European CRO FederationDr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF)
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(9:30-10:30 CET)Regulatory environment of developing clinical trials in Romania – Panel DiscussionChair:Dr. Cristina Florescu Moraid, Director Avantyo Institute of Clinical ResearchSpeakers: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 PharmacyAssoc. Prof. Dr. Diana Paun - Presidential AdvisorProf. Dr. Viorel Jinga, Rector “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaProf.Dr.Adrian Streinu Cercel, President of the Health Commission of the Senate, Romanian ParliamentPharm. Monica Negovan, Director of Pharmaceutical and Medical Devices, Ministry of Health - RomaniaDr. Catalina Sarbu – Head of the CRO Association in Romania (ASSCRC), Director Clinical Operations Parexel International RomaniaDan Zaharescu, The executive director of the Romanian Association of International Drug ManufacturersAssoc. Prof. Dr. Michael Schenker, President of Oncology Comission, Ministry of Health, The founder and manager of “Saint Nectarie” Oncology Center, Romania
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(10:30-11:00 CET)Break
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(11:00-11:30 CET)Innovative therapies in prevention and treatment of COVID-19Tatiana Eidus – Director Corporate Development, ARENSIA Exploratory Medicine Inc. Boston, MA, USA
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(11:30-12:30 CET)View on global COVID-19 vaccination status; status-quo RomaniaChair:Dr. Marius Geanta – President and Co-Founder of Innomed- Center for Innovation in Medicine, RomaniaSpeakers: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 RomaniaAssist.Prof.Col.Dr.Valeriu Gheorghita, President of Vaccination Campaign RomaniaDr.Lucio Fumi - CEO Piramal Enterprises, United KingdomAssoc.Prof.Dr.Simin Aysel Florescu - General Manager “Victor Babes” Hospital, Bucharest, RomaniaDr.Radu Ciprian Tincu - Coordinator Intensive Care Department, “Floreasca” University Hospital, Bucharest, RomaniaDr.Sandra Alexiu - President of Family Physician Association, Bucharest, Romania
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(12:30-13:30 CET)Lunch Break
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(13:30-14:15 CET)Harmonization of Clinical Trials in EU. Latest Updates Related Implementation of CTR 536/2014; Status Quo Romania and CEE countriesChair:Pharm. Mihaela David - Director of Regulatory Affairs - PSI Pharma Support CRO AG, RomaniaSpeakers: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 PharmacyDr. Anna Chioti MD, MPH, MBA, Head of Division Pharmacy and Medicines at Luxembourg Health Directorate, LuxembourgPharm. Lene Grejs Petersen, Senior Adviser, Clinical Trials, Danish Medicines Agency, DenmarkDr. Stefan Strasser, Head of Clinical Trials, Institute Surveillance, AustriaDr. Dagmar Chase, BPI Senior Expert, CEO of Clinrex Munich, GermanyKatarina Kovacova, Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, Slovakia
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(14:15-15:50 CET)Deep dive into decentralized clinical trials - Panel DiscussionChair:Dr.Donato Bonifazzi - CEO Consorzio per Valutazioni Biologoche e Farmacologiche (CVBF) ItalySpeakers:Dr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF); VP Scientific Affairs, Paediatric SME, ICONMirjam Bruggink - Managing Director Clinical Trials Service, The NetherlandsDr. Aleksandra Pesic - President of CRA Academy, SerbiaDr. Janusz Kabata - MBA, PhD-CEO GP4Research, PolandDr. Cristina Florescu Moraid, Director Avantyo Institute of Clinical Research
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(14:50-15:00 CET)AvantYOU - launching Health & Technology Premium Review-published by Avantyo Institute of Clinical ResearchAlexandra Manaila - Medical JournalistDr. Cristina Florescu Moraid - Director Avantyo Institute of Clinical Research
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(15:00-15:15 CET)Break
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(15:15-15:50 CET)Patient Access to Clinical Trials – Panel DiscussionModerator:Rozalina Lapadatu, President of Autoimmune Disease Patients Association, RomaniaSpeakers:Pharm. Dipl. Árpád Kiss – Director Global Clinical Operations Janssen, Hungary & RomaniaDr.Sandra Alexiu - President of Family Physician Association, Bucharest, RomaniaAlina Comanescu - Founder of Community Health Association, RomaniaRadu Ganescu - The president of the Coalition of Organizations of Patients with Chronic Diseases in RomaniaDr. Ioana Bianchi - External Affairs Director, Romanian Association of Drug Manufacturers and Improrters - ARPIMMarinela Debu - President of Hepatic Disease Patient Association, Romania
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(15:50-16:00 CET)CLOSING REMARKS
SPEAKERS




































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