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Oncology Clinical Leaders Forum

Brussels, Belgium - May 11-12, 2015
Presentation

Multilateral recruitment approach for early phase oncology trials: Weights and balances

Related topics: Pharmaceutical/Biotech, Clinical, Global (non-specific), Oncology
Availability: FREE
  • Key challenges in early phase oncology recruitment.
  • Therapeutic, supportive and other compounds from trial management perspective.
  • Pros and cons of early phase trials for the investigator and for the cancer patient.
  • Role and potential of professional CPU (Clinical Pharmacology Unit) within indication.
  • Satellite Centre Concept for proper recruitment and controlled quality.
Speaker

Istvan Udvaros 
Medical Director, Project Director of Oncology
SGS LSS Clinical Research, Belgium

Presentation

Mass balance/ADME studies in oncology patients: Successful answers to the challenge in Central and Eastern Europe

Related topics: Pharmaceutical/Biotech, Europe, Clinical, Central Eastern Europe, Oncology
Availability: FREE
  • Patient pharmacology services: Concept and operational set up.
  • ADME concepts, incl. micro-dose and tracer-dose.
  • Underlying dossier requirements incl. preclinical safety package.
  • General design considerations incl. radiodose and radioburden calculation.
  • Devil is in the details: Operational challenges.
  • Selection of geographic region and patient population.
  • Ethical aspects.
Speaker

Agnes Rethy 
Associate Director of Clinical Operations
EDS Patient Pharmacology Services
PRA Health Services