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REGULATORY SIMPLIFICATION: VISION, OXYMORON, OR ‘MISSION IMPOSSIBLE’?

Track:
Globalisation/Inspections

Day & Time:
March 27, 4:00PM - 5:30PM (Central European Standard Time)

Session Number:
1008

Room Number:
Room LM

Level:
Intermediate

Type:
Session

Title:
REGULATORY SIMPLIFICATION: VISION, OXYMORON, OR ‘MISSION IMPOSSIBLE’?

Chair(s):
Markus Hartmann, DrSc, RAC
Principal Consultant
European Consulting & Contracting in Oncology, Germany

Description:
Regulatory simplification is more than a buzz-word: it reflects concerns from many stakeholders that future global R&D will face serious problems if no adequate equilibrium between necessary public supervision and self-regulation can be established.

Learning Objective(s):
- Attendees should recognize the fundamental normative dimension of self-regulation. - The audience shall interpret the possibilities and pitfalls for high-level initiatives aiming to simplify today’s clinical research environment. - Participants will identify the potential that streamlined, standardized and shared clinical research processes can bear to the overall R&D process.

Presentation(s) & Speaker(s):
Heteronomy versus Autonomy: The normative context for regulatory simplification
Nicola Stingelin
Ethicist
Institute For Biomedical Ethics - Basel University, Switzerland

Self-Regulation in the Clinical Development Process: Pros and cons. An industry perspective
Nick Sykes, MS
Senior Director, Worldwide Safety & Regulatory
Pfizer Inc., United Kingdom

Alliance for Clinical Research Excellence and Safety (ACRES): An initiative to build a globally-shared system infrastructure for clinical research based on standardised operating policies
Brian Edwards, MD, MRCP
Principal Consultant, Pharmacovigilance and Drug Safety
NDA Regulatory Science Ltd, United Kingdom