The leading event for all parties involved in the clinical trials market in CEE

17 - 18 April 2018

Venue to be confirmed

Conference Agenda - Day 1

Day 1

08:30

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Registration and morning coffee
09:25

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Welcome note by the organiser
09:30

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Session 1: The analytical outlook for the clinical trials in Central & Eastern Europe

Title: Latest geographic trends in industry clinical trials - are emerging markets losing their allure?

Vladimir Misik
Founder & Managing Partner
LongTaal
09:50

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Session 2: Update on regulation, compliance, legal & ethical legislative developments
  • Keynote presentation: How a regulatory agency can support earlier access to medical products - agencies in a new role

  • Planning for the Impact of the New EU Clinical Trials Regulation No 536/2014 

  • Advancing Paediatric Clinical Trials in CEE Countries and the Review/Revision of the EU Paediatric Regulation

 

Csilla Pozsgay
Director General
National Institute of Pharmacy and Nutrition (Hungary)
Martine Dehlinger-Kremer
EUCROF President & Vice-President, Global Medical and Regulatory Affairs
SynteractHCR & EFGCP Board Member
Francis Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA) & Ethics Working Group, European Academy of Paediatrics (EAP), Belgium
11:10

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Coffee and networking
11:40

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Session 3: Patients – the cornerstone of the clinical trials
  • Role of patients and patients’ organisations in the clinical trials 

  • Social media campaign in clinical study subject recruitment

  • Real time electronic feasibility for realistic site selection and patient recruitment

  • Accelerating enrolment by a network of referring physicians

Tunde Koltai
Head / President
BEMOSZ (Association of Patients' Organisations in Hungary) /Hungarian Coeliac Society
István Balla
MD, Country Head, Hungary, Site Management & Monitoring, EMEA, R&D, Clinical Operations
AbbVie
Barış Erdoğan
PhD, Head of EEMEA Region
Clinerion Ltd.
Márta Kovácsné Gyulai
Business Development Manager
Spicy Analytics
13:20

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Lunch
14:20

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Effective monitoring of clinical investigations and management of clinical trials: Case studies and practical exchange
  • Achieving Best Practices with Regards to Risk-Based Monitoring

  • Build bridges for stronger relationship

  • Empowering Research with Risk-Based Analytics and Mobile Engagement

Francis Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA) & Ethics Working Group, European Academy of Paediatrics (EAP), Belgium
Zoltan Koleszar
Site Relationship Operational Lead (Hungary, Slovakia, Czech Republic and Ukraine)
Merck
Fotis Stathopoulos
Chief Executive Officer
Infoset
15:30

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Coffee and networking
16:00

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Session 5: Investigators’ panel: What does it take to increase the speed and maintain the high quality research? What would improve on the quality of the CI process?
  • Role of paediatric clinical research networks in improving research quality and standards
  • Do we really have to hire CT managers at sites?
  • Clinical studies at the University of Debrecen, Role of the Coordinator Center for Drug Development
Ottó Skorán
MD, President of Board, MCRN Hungary and Chief Executive Officer
Svabhegy Paediatric Hospital
Katarzyna Juszczyńska
MD, MPH, Organisation and Management of Clinical Trials, Programme Director
Lazarski University (Poland)
Dénes Páll
MD, PhD, DSci, Director of Coordinator Center for Drug Development and Vice-Director
Department of Medicine, University of Debrecen (Hungary)
17:20

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Spotlight presentation: The role of the COMBACTE public-private consortium in antibiotic - and antibacterial drug development
Ron de Winter
Program Coordinator European Projects
Julius Center for Health Sciences and Primary Care/University Medical Center Utrecht
17:45

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Evening reception & networking