Exhibitor + Presentation: Regina Freunscht, Head of Quality Assurance - "Regulatory Requirements for the Conduct of Clinical Trials in Europe"; Bärbel Fingerhut, Head of Study Operations - "Practical Experience in Pediatric Trials"
Presentation: Regina Freunscht, Head of Quality Assurance - "Qualitätskontrolle und Audits von Prüfzentren – Auswahlkriterien, häufige Mängel, Gegenmaßnahmen"
Presentation: "Writing Global Clinical Submission Dossiers using the Common Technical Document" - Stephen de Looze, PhD, ELS, Head of Medical Writing and Document Management
Exhibitor + Presentation: Regina Freunscht, Head of Quality Assurance - "European Regulatory Requirements for the Conduct of Clinical Trials"; Session Chair: "Successful Implementation of a Quality Management System"
Presentation: "Writing global clinical submission dossiers using the common technical document" - Stephen de Looze, PhD, ELS, Head of Medical Writing and Document Management; "Subject narratives for clinical study reports" - Gail Gerhartz, PhD, Senior Medical Writer
09. - 10.05.2007
Seminar: Die Projektassistenz in der klinischen Forschung
Presentation: Regina Freunscht, Head of Quality Assurance - "Around the World: A Global View on Subject Protection"; "The Clinical Research Team of the Future"; "European Regulatory Inspections"
10. - 12.04.2007
Partnerships with CROs
Location:
Orlando, FL, USA - Rosen Shingle Creek Resort Spa and Golf Course
Exhibitor + Presentation: Wilhelm Horn, PhD, Managing Director; Regina Freunscht, Head of Quality Assurance - "Regulatory Requirements on Subject Information and Consent Procedures"
Booth No.:
316
22.03.2007
Seminar: Konzeption und Design von klinischen Prüfungen
Presentation: Validierung von SAS-Programmen für die Auswertung und Dokumentation klinischer Daten; Prozess, Umfang und Dokumentation der Validierung - Claudia Meurer, Senior Statistical Programmer
27. - 28.02.2007
Seminar: Statistische Grundlagen der Planung und Auswertung klinischer Prüfungen
Presentation: Kurt Löffler, PhD, MSc, Managing Director, Head of Biostatistics, Data Management & IT; Herbert Noack, PhD, Head of Clinical Data Management & Senior Statistician
Presentation: Kurt Löffler, PhD, MSc, Managing Director, Head of Biostatistics, Data Management & IT; Herbert Noack, PhD, Head of Clinical Data Management & Senior Statistician
20.09.2006
The Medical Writing Value Chain: Maximizing Document Power & Update on EU Pharmacovigilance 2005/2006
Presentation: "Subject Information & Consent requirements in Europe"; "Update on EU Clinical Trials Legislation"; "Around the World - Global View on Subject Protection" - Regina Freunscht, Head of Quality Assurance
Exhibitor + Presentation: "From Safe Habor to Open Sea - from in-house CDM to CDM Provider" - Herbert Noack, PhD, Head of Clinical Data Management & Senior Statistician
Presentation: Kurt Löffler, PhD, MSc, Managing Director, Head of Biostatistics, Data Management & IT; Herbert Noack, PhD, Head of Clinical Data Management & Senior Statistician
10.02.2006
Workshop: Medical Writing for Clinical Trial Authorization Applications to the European Union