P1: Amer Alanazi, Assistant Professor of Pharmaceutical Biotechnology, King Saud University, Saudi Arabia
Antifungal efficacy of Amphotericin B loaded plasma beads in treatment of Cryptococcus neoformans infection in mice
P2: Romuald Braun, e-consulting, Uanotau Ltd, Switzerland
Selection of an EDMS/RIM/QMS solution considering on-premises and off-premises approach.
P3: Zsuzsanna Csutor, Director of Pharmacovigilance Services, B&C Consulting, Switzerland
The Silver Lining of the Psmf - Flow Chart Displaying Business and user requirements
P4: Melissa Esteban Soto, Cornelius Schep, Safety Science Leader, F Hoffman-La Roche, Switzerland
Merging three aggregate safety reports into one Integrated Drug Safety Master File
P5: Brian Godman, Senior Researcher, Karolinska Institute, Sweden
Essential to have new models to optimise the managed entry of new drugs in Europe
P6: Anna Kubik, Regulatory Manager, KCR.S.A, Poland
Registration of clinical trials in Serbia and Ukraine – submissions to CA and EC one day before European Union
P7: Sasha Lauks, Analyst, Quintiles Consulting, Inc, UK
The effect of Patient Reported Outcomes on Health Technology Assessment recommendations in Oncology in France, Germany and UK
P8: Michael Marx, Associate Medical Director, Icon Clinical Research, Germany
Improvement of 24/7 Medical Emergency Coverage for both regional and global studies by using a single, global approach
P9: Deirdre McCarthy, Director, Integrated Post-Marketing and QPPV Services, Customer Safety Services, Quintiles Ireland, Ireland
Advances in the understanding of depression and the safety profile of novel therapeutic strategies
P10: Toshinori Murayama, Deputy Director and Associate Professor, Kyoto University Hospital, Japan
Kyoto University Hospital Institute for Advancement of Clinical and Translational Science (iACT), aiming at a worldwide ARO
P11: Darshan Patel, Associate Director Regulatory Affairs, Sunovion Pharmaceuticals Inc., USA
Comparison of Clinical Trial Application Approval Rates for Global, Placebo-Controlled Versus Comparator-Controlled Studies
P12: Krista Payne, Executive Director and Principal Scientific Consultant, Dara Stein, Senior Research Scientist United Biosource Corporation (UBC), Canada
Retrospective chart review studies and safety reporting requirements: issues and considerations
P13: Ludivine Pennaneach, Solution Specialist, Thomson Reuters, France
30 Years of the Hatch Waxman Act of 1984: Will three decades of growth in small molecule generics be followed by biosimilars?
P14: Richard Preston, Professor Clinical Medicine, Director, Clinical Pharmacology Research, University of Miami, USA
Effects of Nebivolol versus Metoprolol on Sodium Sensitivity and Renal Sodium Handling in Hypertensive Postmenopausal Women
P15: Badri Rengarajan, Senior Medical Director, Evidera, USA
Using Virtual Population Simulation to Identify Possible Areas of Cardiovascular Safety Concern
P16: Hege Roenning, Managing Director Norway, Lindeq, Norway
Reporting of serious undesirable effects (SUEs) in compliance with Regulation No 1223/2009
Accepted Student Poster Abstracts
SP1: Ana Begic, Faculty of Pharmacy and Biochemistry, University of Zagreb, Croatia
Biomedical potential of Stevia - Stevia rebaudiana (Bert.) Bertoni
SP2: Charlotte Benoit, Samer Bounni, Université Claude Bernard Lyon 1, France
ACE-inhibitors for the prevention of sudden cardiac death: a meta-analysis of randomised
SP3: Pauline Blanchard, Vanessa Ville, Claude Bernard University, France,
Incidence of hypersensitivity reactions (HSR) to oxaliplatin (OP), identification and meta-analysis of potential risk factors.
SP4: Jessica Bonnefoy Isabelle Delfour, Gwenaelle Denis, Eudipharm, France
Designs for Phase I clinical trials in pediatrics. Comparison of methodologies to determine the efficacious dose.
SP5: Katarina Iric, Faculty of Pharmacy, Serbia
Testing the impact of modified reformatsky reaction on the synthesis of 3,3-bis-(4-chlorophenyl)-3-hydroxypropionic acid.
SP6: Monica Luca, University of Medicine and Pharmacy Carol Davila Bucharest, Romania
Evaluation of the non-clinical action of alpha-lipoic acid on Vincristine- and Paclitaxel-induced neuropathic pain.
SP7: Alexia Malriq, Hospices Civil De Lyon, University of Lyon, France,
Clinical Trial Data Sharing: Public access to clinical trials data on medicinal products is coming soon
SP8: Florence Margraff, Hospices Civil De Lyon, University of Lyon, France.
Adverse drug reaction reporting by patients in fifty countries.
SP9: Monika Mironiuk, Medical University of Gdansk, Poland.
Plasma non-targeted metabolic fingerprinting as a potential prognostic tool for drug-resistant hypertension.
SP10: Julie Mouchet, Lucile Penaud, Université Claude Bernard Lyon I, France
Is there a publication bias for studies assessing the benefit of fatty acids in attention deficit hyperactivity disorder?
SP11: Isabelle Rodrigues, University of Lisbon, Portugal
Ibuprofen promotes age-related bradikinin but not the acethylcholine - induced rat ileal contractility.
SP12: Maidah Sheikh, University of Vienna, Austria
The organic anion transporting polypeptide OATP4A1 may be a target for immunomodulation in early colorectal cancer.
SP13: Indre Šveikauskaite, Lithuanian University of Health Sciences, Lithuania
Differences of lead and nickel ions effects on total protein and metallothioneins synthesis in mice liver.
SP14: Birce Didar Tut, Istanbul University, Turkey
Assessment of risk management approaches in orphan drugs.