AGENDA
20th of November, 2020 – 1 day virtual event-
Registration on the website
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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 Federation of CROs (EUCROF)
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Strategies to Speed Up the Review Timelines by the National Agency For Drugs and Medical Devices in Romania (NADMDR) – Panel DiscussionChair:Dr. Cristina Florescu Moraid, CEO Avantyo Institute of Clinical ResearchLucian Mandruta, Journalist, Blogger, Media Trainer, RomaniaSpeakers:Sorin Petcu, General Manager IQVIA, RomaniaDr. Mirela Vita, National Agency for Medicines and Medical Devices of RomaniaProf. Dr. Constantin Mircioiu, General Secretary of the National Bioethics Commission of Medicines and Medical Devices, RomaniaProf. Dr. Viorel Jinga, Rector “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaProf. Dr. Dragos Vinereanu, President of the Senate of the University of Medicine and Pharmacy "Carol Davila", Bucharest, RomaniaDr. Laszlo Attila, President of the Health Commission of the Senate, Romanian ParliamentDr. 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 ManufacturersDr. Nicolae Fotin, Expert Consultant Media Kompass and 360Medical, Romania
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Break
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Epidemiologic Context of Covid-19 Infection in Romania and EuropeProf. Dr. Adrian Streinu-Cercel - General Manager, National Institute of Infectious Diseases “Prof. Dr. Matei Bals”, Bucharest, Romania
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Impact of the Covid-19 Pandemic upon the Clinical Research Community – Panel DiscussionChair:Dr. Marius Geanta – President and Co-Founder of Innomed- Center for Innovation in Medicine, RomaniaSpeakers:Prof. Dr. Doina Draganescu – Dean Faculty of Pharmacy, “Carol Davila”University of Medicine and Pharmacy, Bucharest, RomaniaAssoc. Prof. Dr. Michael Schenker – The founder and head of “Saint Nectarie” Oncology Center, RomaniaAssoc. Prof. Dr. Vlad Vintila – “Carol Davila” University of Medicine, University Emergency Hospital Bucharest, RomaniaDr. Ovidiu Palea – Founder Provita Medical Center, RomaniaDr. Camelia Grigore – Manager of Clinical Paediatric Hospital of Sibiu, Romania
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Obstacles in Patient Enrollment and Continuation of Site Activities in Times of Covid-19 Pandemic: View from an Academic SiteChair:Dr. Catalina Sarbu – Head of the CRO Association in Romania (ASSCRC), Director Clinical Operations Parexel International RomaniaSpeakers:Prof. Dr. Tudor Ciuleanu – “Iuliu Hateganu” University of Medicine and Pharmacy, National Institute of Oncology Cluj, RomaniaProf. Dr. Dana Lucia Stanculeanu – “Carol Davila”University of Medicine and Pharmacy, Head of Medical Oncology “Prof.Dr.Alexandru Trestioreanu”Oncology Institute, RomaniaDr. Kamen Doxev – Country Manager / Regional Director for Bulgaria, Greece, Turkey and Israel - PSI CRODavid Rosenbaum – Managing Director of Rosenbaum Group, United KingdomDr. Nadia Cheaib – Chairwoman Clingroup, President Health Committee French Chamber Egypt, President Hope MCF, LebanonAssoc. Prof. Dr. Adina Croitoru – Associate Professor at "Titu Maiorescu" University of Medicine, Fundeni Clinical Institute, Bucharest, Romania
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Q & A SESSION
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LUNCH BREAK
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Latest Updates Related to the Implementation of the European Clinical Trials Regulation (Eu) No 536/2014Chair:Dr. Martine Dehlinger Kremer - EUCROF President & VP Scientific Affairs, PRA Health Sciences, GermanySpeakers:Vicki Iassonidou - Associate Director Global Regulatory Clinical Services, PRA Health Sciences, GermanyDr. Sergii Rasputniak, Head of Laboratory and Clinical Practices (GLP, GCP) Audit Office at the State Expert Center of the Ministry of Health, UkraineDr. Mirela Vita, National Agency for Medicines and Medical Devices of RomaniaDr. Lina Gudima, Head of Clinical TrialS Department, Medicines and Medical Devices Agency, Republic of MoldovaKatarina Kovacova, Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, SlovakiaMihaela David, Director of Regulatory Affairs - PSI Pharma Support Romania
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Study Planning and Outsourcing Strategies in 2021: Key Elements of Covid-19 Pandemic With Impact on Study Set-Up And Vendor Selection - Panel DiscussionChair:Dr. Aleksandra Pesic - President of CRA Academy, SerbiaSpeakers:Regis Pignol - Global Group Leader Clinical Pharmacology Operations, Sanofi Aventis, FranceInge de Clercq, Head of Clinical Trials Leaders Phase 1, GALAPAGOS, BelgiumDr. Calin Galaseanu, Vice President & General Manager, Novo Nordisk Hungária Kft.
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BREAK
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PARADIGM - The multi-stakeholder governance framework for patient engagement in EuropeDr. Ingrid Klingmann, President of European Forum for Good Clinical Practice (EFGCP), Belgium
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Patient Perspective for Participating in Clinical Trials in Times of Covid-19 Pandemic: Expectations in Terms of Support from the Site-Personnel, from Authorities, from Treating Physician – Panel DiscussionModerator:Rozalina Lapadatu, President of Autoimmune Disease Patients Association, RomaniaSpeakers:Radu Ganescu, The president of the Coalition of Organizations of Patients with Chronic Diseases in RomaniaDr. Janusz Kabata, General Manager GP4Research, PolandMichaela Vancova, Clinical Operations Director, Slovak Research Center, SlovakiaAlina Comanescu, Founder of Community Health Association, Romania
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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 anca.bejenaru@avantyo.com