- 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
- 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
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
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
- 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?
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
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
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)
- 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