Programme

October 22 download agenda
8:30 - 09:30
Registration
09:30 - 11:00
Session 1: Conducting clinical trials across multiple regions: factors influencing regional differences and attractiveness
  • Analytical review of the global clinical trials markets: prospects of the development, their specific characteristics, as well as an in-depth analysis of the regional markets and emerging trends.
  • What are the challenges and opportunities that multiregional clinical trials (MRCT) face at present? What makes a country a prime destination for clinical trials?
  • Benchmarking the performance of individual countries against compliance metrics, patient and investigator satisfaction globally. Leveraging access to a larger and more diverse patient base: recruitment, retention in non-European countries. 

Chair: Vladimir Misik, Managing Partner, Longtaal

09:30 – 09:50 Vladimir Misik, Managing Partner, Longtaal

09:50 – 10:10 Piotr Iwanowski, National Board Member of Polish Association for Good Clinical Practice (GCPpl), Warsaw, Poland; Associate Vice President Clinical Research Europe at Wockhardt Bio AG

10:10 – 10:30 Istvan Udvaros, Chief Medical Officer, Cristal Therapeutics

10:30 – 10:50 Rudi Ladenius, Regional Site Advocate (Central Europe and the Middle East), Vertex Pharmaceuticals

10:50 – 11:00 Q&A

11:00 - 11:20
Keynote Presentation and Q&A: Streamlining the regulatory process
  • Embracing expected international regulations – how will the new European laws affect the clinical trials landscape globally?

Lucie Kravackova, Chief of Clinical Department, State Institute for Drug Control, SUKL

11:20 - 11:50
Coffee and Networking Break
11:50 - 12:35
Spotlight session “Beyond the Borders Projects.”

Chair: Sarah Doherty-Fallon, Life-Sciences Industry Delivery Lead, NIHR Clinical Research Network

11:50 – 12:10 Ron de Winter, Programme Manager European Projects, UMC Utrecht

12:10 – 12:30 Sarah Doherty-Fallon, Life-Sciences Industry Delivery Lead, NIHR Clinical Research Network

12:30 – 12:35 Q&A

12:35 - 13:30
Lunch
13:30 - 14:40
Spotlight presentations

Chair: Khushnoor Dastoor, Executive Director & Head of Quality Assurance, PPCE

13.30 – 13:50 Do you need a local partner to speak the local language?

  • Eugene Selivra, Chief Executive Officer, Global Clinical Trials

13.50 – 14:10 Achieving excellence through effective partnerships

  • Maria Russeva-Vitanova, Operations Director, August Research

14.10 – 14:30 How inefficient data reviews at the Data Management end affect the analysis of outcomes on clinical studies. The role of AI

  • Khushnoor Dastoor, Executive Director & Head of Quality

14-30 – 14:40 Q&A

14:40 - 15:10
Coffee and networking break
15:10 - 16:10
Discussion: Risk-Based Monitoring for MRCTs
  • How far along the road is RBM from when the concept was first introduced and how has it evolved?
  • What are the common stumbling blocks in the identification of risks?
  • Where are the communication gaps in a robust RBM methodology and how can we circumvent these?
  • The role of FDA, EMA and other regulatory bodies in the endorsement of RBM methodologies
  • Are there any case studies that could demonstrate the effectiveness of RBM/that could be used as benchmarks by other companies looking to implement RBM?
16:10 - 17:40
Session 7: Spotlight on EAEU & Ukraine

Chair: Vladimir Popov, Professor   Department of pharmacy, Institute of Medical and social technologies, Moscow State University of Food Production, Сlinical  trial Unit  NGHCI “Scientific Clinical Centre”, JSC  Russian Railways (Russia)

16:10 – 16:30 Serhiy Rasputniak, Deputy Department Director, Head, Clinical Audit Unit, Pre-Clinical and Clinical Trial Materials Expert Evaluation Department, The State Expert Centre Ministry of Health of Ukraine (Ukraine)

16:30 – 16:50 Philip la Fleur, Assistant Professor of Practice, Director of Centre for Clinical Trials, Nazarbayev University School of Medicine (Kazakhstan)

16:50 – 17:10 Naia Abshilava, Senior Specialist Of Division Of Permissions, Regulation Agency For Medical Activities, Ministry Of Labour, Health And Social Affairs (Georgia)

17:10 – 17:30 Vladimir Popov, Professor  Department of pharmacy, Institute of Medical and social technologies, Moscow State University of Food Production,  Сlinical  trial Unit NGHCI “Scientific Clinical Centre”, JSC  Russian Railways (Russia)

17:30 – 17:40 Q&A

17:45
One-2-One Meetings & Cocktail Reception

 

 

 

 

October 23 download agenda
09:30 - 10:30
Session 5: Spotlight on CEE & South Europe

Chair: Beata Cecetkova, Clinical Research Director, TWMA

09:30 – 09:45 Jakub Dvořáček, Executive Director of the Association of Innovative Pharmaceutical Industry (AIFP)

09:45 – 10:00 Beata Cecetkova, Clinical Research Director, TWMA

10:00 – 10:20 Darina Hrdličková, Director of Clinical Management, PPD

10:20 -10:30 Q&A

10:30 - 11:00
Coffee and Networking
11:00 - 12:10
Session 6: Spotlight on Turkey & MENA

Chair: Hamdi Akan, Ankara University Medical School, Dept. of Haematology

11:00 – 11:20 Betül Erdoğan, Clinical Research Director, GCTO Turkey, Middle East, Egypt, MSD

11:20 – 11:40 Nihal El Habachi,Executive Director, Alexandria Clinical Research Centre

11:40 – 12:00 Ahmad Al-Ghzawi,President & CEO, TRIUMPHARMA (Jordan)

12:00-12:10 Q&A

12:10 - 13:10
Lunch
13:10 - 15:30
Session 7: Site Management
  • Do sites in different regions require different levels of site management? What support do investigators and the sites require from sponsors and CROs?
  • With the innovative solutions advancing and study procedures becoming more complex – would new sites and emerging clinical trials players be able to meet new expectations standards?
  • Reducing expenditures in site management – what are the cost-saving monitoring models and cost optimising solutions that being used? Role of risk-based monitoring (RBM) for improving site management
  • Working with complex protocols: how could the changing role of a clinical monitor affect a site’s ability to manage complex studies?
  • Liaison with the local ethics committees – how significant is the problem for established and new markets?

Chair: Rudi Ladenius, Regional Site Advocate (Central Europe and the Middle East), Vertex Pharmaceuticals

13:10 – 13:30 Igor Bondarenko, Head of Oncology & Medical Radiology Dpt, Dnipropetrovsk Medical Academy (Ukraine)13:30 -13:50

13:30 – 13:50 David Strhan, Manager Site Network, International Research Network and Clinical Operations Manager, FindMeCure

13:50 – 14:10 Michaela Vančová, Clinical Operations Director, Slovak Research Center S.R.O.

14:10 – 14:30 Mehmet Yildiz, Owner, MEDEX SMO

14:30 – 14:50 Hamdi Akan, Ankara University Medical School, Dept. of Haematology (Turkey)

14:50 – 15:10 Bartosz Kozak, Clinical Research Director, EMC SA / PENTA HOSPITALS INTERNATIONAL (with a Spotlight Presentation: Budgets, Contracts & Payments Management)

15:10 – 15:30 Q&A