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THE NEW PARADIGM IN CLINICAL RESEARCH: STAKEHOLDER PERSPECTIVES FOR A RATIONAL PROCESS

Track:
Innovation in Clinical Research

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
0606

Room Number:
F1

Type:
Session

Title:
THE NEW PARADIGM IN CLINICAL RESEARCH: STAKEHOLDER PERSPECTIVES FOR A RATIONAL PROCESS

Chair(s):
Peter G. Stokman, MSc
Head Global Data Management & Standards Oss
Merck Sharp and Dohme, Netherlands

Clara Heering
Vice President Clinical Risk Management
ICON Clinical Research, Netherlands

Description:
In the first part, the speakers focus on the rationale and applicability of prioritising limited resources to crucial sectors. Key regulatory documents are analysed and drivers such as ‘proportionality’ are reviewed. In the second part, ‘complicating factors’ are discussed in small groups. This is a challenge to the audience to think freely on how to break away from company culture and thinking, and to provide and justify ideas for reconfiguring the current process. The complicated factors covered are: the fragmentation of responsibilities linked to the specialization of service providers; risk aversion and the reluctance to change current practices; business practices which stifle innovation; misconstrued and over-interpreted regulatory requirements which lead to perverse results.

Presentation(s) & Speaker(s):
Current Pharma Solutions to Address Protocol Data Relevance
Stella Stergiopoulos
Senior Project Manager
Tufts Center for the Study of Drug Development, United States

Data driven clinical development: a means by which the pharmaceutical industry can improve its productivity and efficiency
Sarah Athey, MBA, MSc
Director, European Consulting
Quintiles, United Kingdom

Ana Rodriguez, PhD
Head of Clinical and Non-Clinical Compliance
European Medicines Agency, European Union, United Kingdom

Gabriele Schwarz
Head, GCP Inspection Services
BfArM, Germany