01
08:30 AM 09:30 AM
Registration Opens / Welcome coffee
09:30 AM 09:40 AM
Welcome / Catalin Stefanescu
09:40 AM 10:20 AM
01
Presentation Sessions:

  • 09:40 - 10:00 - Sandesc Dorel, MD, PhD, 'Opening Speech', Secretary of State - Romanian Ministry of Health


  • 10:00 - 10:20 - Mirela Vita, MD, 'Regulatory Framework for Clinical Trials in Romania', Clinical Trial Unit, National Agency of Medicines and Medical Devices - Romania
10:20 AM 10:45 AM - Coffee Break
 
10:45 AM 12:05 AM
01
Presentation Sessions:

  • 10:45 - 11:05 - Edward Jensen, PMP, 'Management of Strategic Partnerships in Clinical Trials', Consultant to Chief Medical Officer, Biogen – USA
  • 11:05 - 11:25 - Calin Galaseanu, MD, 'Clinical Trials - from Innovation to Patient Benefits', General Manager - Bristol-Myers Squibb Romania and President of ARPIM Pharma Association - Romania
  • 11:25 - 11:45 - Jens Dollerup, MSc, 'Clinical Trials in the Future, be on the Studies for Regulatory Purposes: What Could be the Role and Opportunities for CRO's/SMO's in the Future?' - Denmark
  • 11:45 - 12:05 - Sabina Marcu, MD, 'To Outsource or Not to Outsource Clinical Trials' Medical Director, Boehringer Ingelheim - Romania
12:05 AM 14:00 PM - Business Lunch
 
14:00 AM 15:50 AM
01
Presentation Sessions:

  • 14:00 - 14:20 - Teresa Diaz Garcia, RN, 'My Experience as Clinical Research Manager Working with CEE - Harnessing the Potential', Principal Clinical Research Manager, Europe II & Intercontinental Regional Clinical Operations, Merck Group - Spain
  • 14:20 - 14:40 - Eduard Prisacariu, MD, 'Challenges to the Operational Excellence in Clinical Studies. What about the Public Perception?' Medical Director, Sanofi Aventis - Romania
  • 14:40 - 15:00 - Ivan Georgiev, MD, 'Overview of Clinical Trials Market in Bulgaria', Managing Director of Quintiles Bulgaria and Chairman of the Bulgarian Association of Clinical Research - Bulgaria
  • 15:00 - 15:20 - Bujor Almasan, MD, Ph.D., 'Impact of Technology in Clinical Research', Country Manager, Quintiles Romania and President of the ACCSCR - Romania
  • 15:20 - 15:50 - Alexander Oscar, MD, PhD, 'Why to do Business in Bulgaria and the Role of the Ethics Committee?' Chairman of the Ethics Committee for Multicenter Clinical Trials - Bulgaria
15:50 AM 16:20 PM - Coffee Break
 
16:20 AM 18:00 AM
01
Presentation Sessions:

  • 16:20 – 16:40 Boyan Doganov, MD, 'Ethics Committees in EU Member States – Myths and Reality', Vice-Chairman of the Ethics Committee for Multicenter Trials - Bulgaria
  • 16:40 – 17:00 Simona Olaru, MD, 'Postmarketing Studies', Medical Director, Bristol-Myers Squibb - Romania
  • 17:00 – 17:20 Cristina Pentiuc, MD, 'Trends in Market Access Strategy and Benefits from Health Economics Studies', Market Access Director, Bristol-Myers Squibb, Leader of ARPIM Policy Group - Romania
  • 17:20 – 17:40 Joachim Linke, MD, MSc, 'Outsourcing in Drug Development, Market Access and Drug Marketing – Does it Make Sense to Use an External Service Provider?', Creative Clinical Research GmbH/IMETICS - Germany
  • 17:40 – 18:00 Alexandru Sirbu, MD, 'Clinical Trials in Moldova – Country Advantages', GCP Inspector National Agency of Medicine and Medical Devices - Republic of Moldova

18:00 PM 18:05 PM

Chair Closing Remarks & End Of Day One
18:05 AM 20:00 PM - Networking
 
20: 00 PM - Dinner
02
08:30 AM 09:30 AM
Registration Opens / Welcome coffee
09:30 AM 09:40 AM
Welcome / Catalin Stefanescu
09:40 AM 10:20 AM
01
Presentation Sessions:

  • 09:40 – 10:00 - Tausif Monif, Ph.D., 'Sponsor Expectations on Outsourced Human PK Studies in Context of Global Regulatory Requirements', Vice-President Clinical Pharmacology & Pharmacokinetics, Sun Pharma - India
  • 10:00 - 10:20 - Florina Prundaru, MD, 'Conducting Clinical Research in Eastern Europe. From Challenges to Success', Clinical Research Director Romania & Bulgaria, Merck Sharpe & Dome - Romania
10:20 AM 10:45 AM - Coffee Break
 
10:45 AM 12:00 AM
01
Presentation Sessions:

  • 10:45 - 11:05 - Daniel Da Costa, PhD, 'Physiological Intermolecular Modulation Spectroscopy (PIMS), an Innovative Technology for Prediction of Treatment Outcomes Prior to Clinical Trials', Business Developer Manager, Inoviem Scientific - France

  • 11:05 - 11:30 - Marika Pecena, MD, 'Local Clinical Studies in Russia and Registration of Generics', Clinical Research Consultant - Czech Republic

  • 11:30 - 12:00 - Cornelia Preda, MD, 'Ethics – an Old and New Dimension of Clinical Research', Regional Ethics and Compliance Manager for Romania, Bulgaria and Baltic States AbbVie
12:00 AM 14:00 PM - Business Lunch
 
14:00 AM 16:00 AM
01
Presentation Sessions:

  • 14:00 – 14:30 Adrian Udrea, MD, 'Medisprof - Clinical Trials Site Presentation', Chief Medical Officer, Medisprof - Romania


  • 14:30 – 14:50 Mihai Manolache, MSc 'Clinical Research Emerging Markets & Trends in the Global Economy Context', Chief Executive Officer, CEBIS International

  • 14:50 – 15:15 Pavel Tverdochleb, MD 'The Advantages and Challenges of Conducting Clinical Trials in Georgia', Clinical Development Consultant - Russia
  • 15:15 – 15:40 Cristian Ducu, PhD, 'Ethical Assessment of Clinical Trials in Romanian Medical Environment', General Manager, Centre In Advanced Research Management and Applied Ethics - Romania
  • 15:40 – 16:00 Julian V. Platon, MD, PhD, 'Critical Clinical Operations Factors: Why "Go East"?', Global Medical Director, GastroIntestinal & Liver Health Established Pharmaceuticals, Abbott - Switzerland
16:00 AM 16:30 PM - Coffee Break
 
16:30 AM 18:00 AM
01
Presentation Sessions:

  • 16:30 – 17:00 Acad. Constantin Mircioiu, PhD, 'Avoid the Use of Excessive or Inadequate Numbers of Research Subjects in CT', National Bioethics Committee - Romania and Professor at the University of Medicine & Pharmacy, Carol Davila, Bucharest
  • 17:00 – 17:30 Javier Llop Ruperez, MD, 'Sponsor's Expectations Related to Outsourcing Clinical Trials on Medical Devices', Medical Director, Noventure - Spain

  • 17:30 – 18:00 Marius Marusteri, Pharm.D, MSc, PhD, 'Pay Attention to your Data! The Misuse of Statistics in Clinical Trials', Head of Medical Informatics and Biostatistics Dept., Chairman of Academic Management & European Integration Dept., University of Medicine and Pharmacy Tirgu Mureş - Romania

17:45 PM 18:00 PM

Chair Closing Remarks & End Of Day Two