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
Dr. Martine Dehlinger Kremer
President of European CRO Federation - EUCROF and & VP Scientific Affairs - PRA Health Sciences, Germany
Prof. Dr. Adrian Streinu-Cercel
General Manager of the National Institute of Infectious Diseases “Prof. Dr. Matei Bals", Romania
Dan Zaharescu
The Executive Director of the Romanian Association of International Drug Manufacturers (A.R.P.I.M)
Dr. Mirela Vita
Lead of Clinical Trials Department at the Romanian National Agency for Drugs and Medical Devices, Romania
Prof. Dr. Viorel Jinga
Rector of the “Carol Davila” Medicine and Pharmacy University Bucharest, Romania
Dr. Nadia Cheaib
Chairwoman Clingroup, President Health Committee French Chamber Egypt, President Hope MCF, Lebanon
Sorin Petcu
General Manager of IQVIA, Romania
Prof. Dr.Constantin Mircioiu
General Secretary of the National Bioethics Commission of Medicines and Medical Devices, Romania
Inge de Clercq
Head of Clinical Trials Leaders Phase 1
GALAPAGOS, Belgium
Mihaela David
Director of Regulatory Affairs - PSI Pharma Support, Romania
Alina Comanescu
Founder of Community Health Association, Romania
Dr. Laszlo Attila
President of the Health Commission of the Senate, Romanian Parliament
Prof. Dr. Dragos Vinereanu
President of the Senate of the University of Medicine
and Pharmacy "Carol Davila", Bucharest, Romania
Dr. Camelia Grigore
Manager of Clinical Paediatric Hospital of Sibiu, Romania
Assoc. Prof. Dr. Diana Paun
State Advisor of the Romanian President, Romania
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.Janusz Kabata
General Manager GP4Research, Poland
Prof. Dr. Tudor Ciuleanu
“Iuliu Hateganu” University of Medicine and Pharmacy, National Institute of Oncology Cluj, Romania
Dr. Aleksandra Pesic
President of CRA Academy, Serbia
Regis Pignol
Global Group Leader Clinical Pharmacology Operations, Sanofi Aventis, France
Michaela Vancova
Clinical Operations Director, Slovak Research Center, Slovakia
Assoc. Prof. Dr. Vlad Vintila
“Carol Davila” University of Medicine, University Emergency Hospital Bucharest, Romania
Assoc. Prof. Dr. Adina Croitoru
"Titu Maiorescu" University of Medicine, Fundeni Clinical Institute, Romania
Dr. Catalina Sarbu
Head of the Romania Association CCRO, (ACCSCR), Romania
Dr. Kamen Doxev
Country Manager / Regional Director for Bulgaria, Greece, Turkey and Israel - PSI CRO
Lucian Mandruta
journalist, blogger, media trainer, Romania
Dr. Nicolae Fotin
Expert Consultant Media Kompass and 360Medical, Romania
Vicki Iassonidou
Associate Director, Global Regulatory Affairs at PRA Health Sciences, Germany
Prof. Dr. Dana-Lucia Stanculeanu
“Carol Davila”University of Medicine and Pharmacy, Head of Medical Oncology “Prof.Dr.Alexandru Trestioreanu”Oncology Institute, Romania
Dr. Ingrid Klingmann
President of European Forum for Good Clinical Practice (EFGCP), Belgium
David Rosenbaum
Managing Director of Rosenbaum Group, United Kingdom
Dr. Calin Galaseanu
Vice President & General Manager, Novo Nordisk Hungária Kft.
Katarina Kovacova
Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, Slovakia
Dr. Lina Gudima
Head of Clinical TrialS Department, Medicines and Medical Devices Agency, Republic of Moldova
Prof. Dr. Pharm. Doina Draganescu
Dean of the Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest
Dr. Marius Geanta
Co-Founder & President at Center for Innovation in Medicine, Romania
Rozalina Lapadatu
President of Autoimmune Disease Patients Association, Romania
Dr. Ovidiu Palea
Founder of "Provita Medical Center", Romania.
Assoc. Prof. Dr. Michael Schenker
Founder and head of “Saint Nectarie” Oncology Center, Romania
Radu Ganescu
The president of the Coalition of Organizations of Patients with Chronic Diseases, Romania
Dr. Cristina Florescu Moraid
President of Clinical Trials Symposium, CEO AVANTYO Institute of Clinical Research, Romania
CONTACT
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