The discussion will cover Insights into trends and predictions as well as growth drivers that attract business to the region; global factors that will affect clinical trials in the CEE and measures to strengthen its competitive advantage. Experts will also raise issues of the latest regulatory initiatives and compliance updates impacting clinical trials in Europe today; results from the impact of Brexit on European trials and insight into the preparations for the implementation of the European data protection law. The 2018 Forum Regulatory Highlights Include: • The Global Landscape of Clinical Trials • The impact of GDPR enforcement on trials in the CEE • Updates of the RODO confidentiality law affecting patient recruitment and data collection • Implementation of ISO141155 clinical investigation of medical devices • A review of the Clinical Data Interchange Standards Consortium (CDISC) regulation 536/2014 EU • Implementing ICH GCP E6 (R2) effectively The agenda will also focus on a number of practical issues including the following: • Practical Patient Recruitment Strategies Revealed • Cost and Financial Planning for Trials • Electronic Solutions for Slow Recruitment in Clinical Trials • Optimising Clinical Performance by Investing in CRO Relationships • Experiences Using Real-Time EHR Based Patient Search/Identification to Accelerate Trials • Optimising Clinical Trials Design for Paediatrics The Forum agenda is available to download: http://www.clinicaltrialscee.com/1146MMOTESZen >> Clinical Trials in Central & Eastern Europe Forum attracts over 120 professionals from more than 20 countries. Its audience includes international and local pharmaceutical companies, biotech companies, CROs, SMOs, investigators and other parties operating or interested in conducting clinical trials in the CEE region. Among the speaker confirmations: • Vladimir Misik, Board Member, SanaClis, Founder & Partner, LongTaal • Ingrid Klingmann, MD, PhD, Chairman, The European Forum for Good Clinical Practice (EFGCP) • Tamás Bereczky, European Patients' Academy for Therapeutic Innovation (EUPATI), EUPATI Germany • Jennifer Preston, Patient and Public Involvement Priority Lead, NIHR Clinical Research Network, UK • Sammy Ainsworth, Parent and Patient Research Ambassador, UK • Michaela Vančová, Clinical Operations Director, Slovak Research Centre, Slovakia • Dr Filip Rybakowski, Head of Child and Adolescent Psychiatry Department, Institute of Psychiatry and Neurology (Poland) • Vesna Popovska, Director Research, Pediatric Neurology & Neurosurgery, UBC Adult Neurosurgery, Canada • Piotr Drobek, Deputy Director of the Social Education and International Department, GIODO, Poland • Ottó Skorán, MD, President of Board, MCRN Hungary and Chief Executive Officer, Svabhegy Paediatric Hospital • Karol Szczukiewicz, Regional Study Manager, Roche, Poland • Oleksii Mikheiev, MD, Verum.de GmbH, Germany • Ramón López, Clinical Research Manager, Thrombotargets Europe • Horea Borogan, Country Manager, Synexus Romania, Romania • Barış Erdoğan, PhD, Head of EEMEA Region, Clinerion Ltd. • Lucie Špatenková, Clinical Operations Manager, CRC s.r.o. Czech Republic You can register online here: http://www.clinicaltrialscee.com/1146MMOTESZren >> VIP Code for a 15% discount: 1146MMOTESZ If you have any queries, please contact Ms Irina Shakhmuratova, i.shakhmuratova@adamsmithconferences.com More details: http://www.clinicaltrialscee.com/?xtssot=0 >>
