AGENDA

20th of November, 2020 – 1 day virtual event
  • Registration on the website
    09:30 10:00
  • 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 Federation of CROs (EUCROF)
    10:00 10:15
  • Strategies to Speed Up the Review Timelines by the National Agency For Drugs and Medical Devices in Romania (NADMDR) – Panel Discussion
    Chair:
    Dr. Cristina Florescu Moraid, CEO Avantyo Institute of Clinical Research
    Lucian Mandruta, Journalist, Blogger, Media Trainer, Romania
    Speakers:
    Sorin Petcu, General Manager IQVIA, Romania
    Dr. Mirela Vita, National Agency for Medicines and Medical Devices of Romania
    Prof. Dr. Constantin Mircioiu, General Secretary of the National Bioethics Commission of Medicines and Medical Devices, Romania
    Prof. Dr. Viorel Jinga, Rector “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
    Prof. Dr. Dragos Vinereanu, President of the Senate of the University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
    Dr. Laszlo Attila, President of the Health Commission of the Senate, Romanian Parliament
    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
    Dr. Nicolae Fotin, Expert Consultant Media Kompass and 360Medical, Romania
    10:15 11:00
  • Break
    11:00 11:30
  • Epidemiologic Context of Covid-19 Infection in Romania and Europe
    Prof. Dr. Adrian Streinu-Cercel - General Manager, National Institute of Infectious Diseases “Prof. Dr. Matei Bals”, Bucharest, Romania
    11:30 12:00
  • Impact of the Covid-19 Pandemic upon the Clinical Research Community – Panel Discussion
    Chair:
    Dr. Marius Geanta – President and Co-Founder of Innomed- Center for Innovation in Medicine, Romania
    Speakers:
    Prof. Dr. Doina Draganescu – Dean Faculty of Pharmacy, “Carol Davila”University of Medicine and Pharmacy, Bucharest, Romania
    Assoc. Prof. Dr. Michael Schenker – The founder and head of “Saint Nectarie” Oncology Center, Romania
    Assoc. Prof. Dr. Vlad Vintila – “Carol Davila” University of Medicine, University Emergency Hospital Bucharest, Romania
    Dr. Ovidiu Palea – Founder Provita Medical Center, Romania
    Dr. Camelia Grigore – Manager of Clinical Paediatric Hospital of Sibiu, Romania
    12:00 12:45
  • Obstacles in Patient Enrollment and Continuation of Site Activities in Times of Covid-19 Pandemic: View from an Academic Site
    Chair:
    Dr. Catalina Sarbu – Head of the CRO Association in Romania (ASSCRC), Director Clinical Operations Parexel International Romania
    Speakers:
    Prof. Dr. Tudor Ciuleanu – “Iuliu Hateganu” University of Medicine and Pharmacy, National Institute of Oncology Cluj, Romania
    Prof. Dr. Dana Lucia Stanculeanu – “Carol Davila”University of Medicine and Pharmacy, Head of Medical Oncology “Prof.Dr.Alexandru Trestioreanu”Oncology Institute, Romania
    Dr. Kamen Doxev – Country Manager / Regional Director for Bulgaria, Greece, Turkey and Israel - PSI CRO
    David Rosenbaum – Managing Director of Rosenbaum Group, United Kingdom
    Dr. Nadia Cheaib – Chairwoman Clingroup, President Health Committee French Chamber Egypt, President Hope MCF, Lebanon
    Assoc. Prof. Dr. Adina Croitoru – Associate Professor at "Titu Maiorescu" University of Medicine, Fundeni Clinical Institute, Bucharest, Romania
    12:45 13:15
  • Q & A SESSION
    13:15 13:30
  • LUNCH BREAK
    13:30 14:30
  • Latest Updates Related to the Implementation of the European Clinical Trials Regulation (Eu) No 536/2014
    Chair:
    Dr. Martine Dehlinger Kremer - EUCROF President & VP Scientific Affairs, PRA Health Sciences, Germany
    Speakers:
    Vicki Iassonidou - Associate Director Global Regulatory Clinical Services, PRA Health Sciences, Germany
    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. Mirela Vita, National Agency for Medicines and Medical Devices of Romania
    Dr. Lina Gudima, Head of Clinical TrialS Department, Medicines and Medical Devices Agency, Republic of Moldova
    Katarina Kovacova, Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, Slovakia
    Mihaela David, Director of Regulatory Affairs - PSI Pharma Support Romania
    14:30 15:00
  • Study Planning and Outsourcing Strategies in 2021: Key Elements of Covid-19 Pandemic With Impact on Study Set-Up And Vendor Selection - Panel Discussion
    Chair:
    Dr. Aleksandra Pesic - President of CRA Academy, Serbia
    Speakers:
    Regis Pignol - Global Group Leader Clinical Pharmacology Operations, Sanofi Aventis, France
    Inge de Clercq, Head of Clinical Trials Leaders Phase 1, GALAPAGOS, Belgium
    Dr. Calin Galaseanu, Vice President & General Manager, Novo Nordisk Hungária Kft.
    15:00 15:30
  • BREAK
    15:30 15:45
  • PARADIGM - The multi-stakeholder governance framework for patient engagement in Europe
    Dr. Ingrid Klingmann, President of European Forum for Good Clinical Practice (EFGCP), Belgium
    15:45 16:15
  • 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 Discussion
    Moderator:
    Rozalina Lapadatu, President of Autoimmune Disease Patients Association, Romania
    Speakers:
    Radu Ganescu, The president of the Coalition of Organizations of Patients with Chronic Diseases in Romania
    Dr. Janusz Kabata, General Manager GP4Research, Poland
    Michaela Vancova, Clinical Operations Director, Slovak Research Center, Slovakia
    Alina Comanescu, Founder of Community Health Association, Romania
    16:15 16:45
  • CLOSING REMARKS
    16:45 17:00


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SPEAKERS

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

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

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