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Tutorials & Workshops

Pre-conference Tutorials and Workshops take place on Monday, 8 October 2012.

For details please consult the Advance Programme.

09:00–12:30 Tutorial 1
CDISC STANDARDS: FROM PROTOCOL TO FDA SUBMISSION
Co-Instructors:
Pierre-Yves Lastic, Senior Director, Data Privacy and Healthcare Interoperability Standards, Sanofi, France
FDA Instructor invited

CANCELLED 09:00–12:30 Tutorial 2
PERSONAL DATA PROTECTION IN CLINICAL TRIALS AND PHARMACOVIGILANCE
Tutorial instructor
Anne Bahr, Deputy R&D Data Privacy Officer, Sanofi, France

09:00–12:30 Workshop 1
THE FUTURE OF THE REGULATORY CLINICAL TRIALS ENVIRONMENT
Workshop Co-Chairs:
Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium
Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany

09:00–12:30 Workshop 2
RISK-BASED MONITORING
Workshop Co-Chairs:
Heike Schön, Managing Director, CSG Clinische Studien GmbH, Germany
Julianne Hull, CEO, WenStar Enterprises, UK

09:00–12:30 Medical Information and Communications Pre-Conference Workshop
OPERATIONAL EXCELLENCE WORKSHOP

Victoria Dalensi, Associate Director International Medical Communications ADHD, Clinical Development and Medical Affairs, Shire AG, Switzerland

Workshops are part of your conference registration.

Tutorials require separate registration at additional cost.

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