Agenda & Venue | Clinical Trials Symposium

AGENDA

19^th of November, 2021 – 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

Innovative trials designs in a post pandemic era
Harmonization of Clinical Trials in EU: status Quo Romania
Efficient outsourcing strategies in clinical trials
Deep dive into decentralized clinical trials
Patient access to clinical trials
Ai technologies transforming clinical trials
Latest developments in anti-COVID therapies and vaccines
View on global COVID-19 vaccination status; status-quo Romania

More details are coming soon!

SPEAKERS

Dr. Martine Dehlinger Kremer President of European CRO Federation - EUCROF and & VP Scientific Affairs - PRA Health Sciences, Germany

Árpád Kiss, PharmD Pharmacist (MPh. - summa cum laude) Adept of Professional Diplomacy (cum laude) DIRECTOR GCO Hungary & Romania Janssen, Global Clinical Operations

Assoc. Prof. Diana Paun Presidential Advisor

Mihaela David Director of Regulatory Affairs - PSI Pharma Support 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 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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