The premier meeting-place for the Clinical Trials sector in Central & Eastern Europe

28-29 May 2019

Conference Agenda - Day 1

Day 1

09:00

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Registration and Morning Coffee
09:45

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Welcome speech from Adam Smith Conferences
09:50

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Session 1 The Latest Regulatory Changes Impacting Clinical Trials in CEE
  • The latest regulatory changes: how will they be applied in practice?
  • How far will the EU Clinical Trial Regulation No. 536/2014 streamline the regulatory process of CT in CEE? 
  • The Health Technology Assessment (HTA): An overview of the HTA and its role in clinical trials. What is the clinical effectiveness of the HTA? What's the future of HTA data?
  • The new European Data Privacy Regulation: what is the experience to date and the impact on implementing Clinical Trials?
  • Adherence to the GCP rules ICH GCP E6 (R2): How are the rules being enforced? How important are these rules for Clinical Trials?
  • EU Clinical Trial Regulation
Masha Komnenic
Information Security and Data Privacy Specialist | Certified Data Protection Officer (CIPP/E AND PECB DPO)
Axiom International
Francis Crawley
Executive Director
Good Clinical Practice Alliance - Europe (GCPA), Belgium
&
Strategic Initiative for Developing Capacity in Ethical Review
(SIDCER), Belgium
Vladimir Vujovic
Deputy Country Manager Serbia & Regulatory and Safety Manager
Optimapharm
10:50

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Session 2: Geographic Trends in Clinical Trials in CEE countries: a comparative analysis of challenges and opportunities across the region
  • CT in Poland, Czech Republic, Hungary, Bulgaria, Baltic countries, Romania, Ukraine and Belarus etc.
  • Analysis of the speed of patient enrolment in the CEE region: KPIs
  • Country selection for Clinical Trials – key factors and performance benchmarking: costs, quality, growth prospects
  • Current network status in CEE: development of platforms for facilitating partnerships in the region?
Beata Cecetkova
Clinical Research Director
TWMA Clinical Research and Pharmacovigilance, Czech Republic
Radu Costin Ganescu
President
National Coalition of organisations for patients with chronic conditions of Romania (COPAC)
&
Treasurer
European Patients Forum
Innovative strategies in investigator-initiated clinical research: the Hungarian experience
Gabor L. Kovacs
President
University of Pécs, Szentagothai Research Centre, Academy of Science Hungary
Maja Conkic
Vice President
Association for Advancement of Clinical Research of Serbia KLINIS
&
Managing Director
Axiom International
Roman Serguchev
Clinical Trial Manager
Avva Rus (AVVA Pharmaceuticals AG)
Michaela Vančová
Clinical Operations Director
Slovak Research Centre, Slovakia
12:35

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Coffee & Networking Break
13:00

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Keynote Presentation – Whether clinical development can be powered by RWE?
  • •       Real World Evidence (RWE) – what is it and what can it tell us?

    •       What are the obstacles to utilising RWE?

    •       RWE in CT planning: how to optimise clinical trial design and patient recruitment using RWE?

Deyan Mehandjiev
MD,PhD PVG Manager
PPD (former RWE Cluster Lead, Novartis)
13:20

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Lunch
14:30

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Session 2: Logistics and Supply Chain in Clinical Trials

How to develop better practices and implement new technologies for a clinical trial supply chain in CEE countries?

How to overcome potential operational challenges in clinical trials?

The ways Air Cargo industry can improve the handling of pharmaceutical shipments

 

 

Raffaele Laciti
Product Manager, Clinical Trial Supply
World Courier
Michaela Vančová
Clinical Operations Director
Slovak Research Centre, Slovakia
15:15

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Session 3: Panel Discussion: Innovations and New Technologies in Clinical Trials – How to leverage new technologies to advance clinical research?
  • The use of sensors, IoT and Big Data analytics in CT – what are the possibilities?
  • Enhancing information exchange between patients and clinical trials (mHealth,  mobile devices and wearable technologies in clinical trials) – the benefits and challenges of utilisation?
  • Risk-based management and monitoring: trends and technologies
  • Introduction of Remote Monitoring: pros and cons
  • Blockchain in CT
  • Machine-Learning & Artificial Intelligence in clinical trials – emerging applications to improve CT efficiency: experience of implementation to date
Eddie Guzdar
Medical Head - Neuroscience
Sanofi Genzyme UKIE
Alain Bindels
Head of Innovation Facilitation
Roche
Isabelle Naeije
Assoc. Global Trial Director
Novartis
Balázs Bende
M.D., Professional leader at Clinical Research Coordination Centre
University of Szeged
16:15

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Coffee & Networking Break
16:45

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1-to-1 meetings with Pharma Companies, Biotech and CROs

 

1-to-1 meetings offer an invaluable opportunity to meet and collaborate with pharma & biotech executives and CROs - in person. Leading companies will be represented by their clinical research specialists. Meetings will last 10 minutes, allowing you to introduce your company and service, align your offerings, and establish direct contact with top managers for future collaboration.

The number of meetings available is limited. Register your delegate place early for priority in booking meeting slots with Pharma, Biotech and CRO leaders!

 

18:15

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Cocktail & Networking Reception
For Speaker Opportunities Please Contact: Diana Koumi: Tel: +44 7507744603 D.koumi@adamsmithconferences.com