Module 5 Presentations

18/07/2024

Terminology

Randomisation

Blinding

IMP

Protocol

Informed Consent

NIMP

Placebo effect

The Organisation for Professionals in Regulatory Affairs

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Distribution Management

• On-time delivery with product quality maintained is a critical success factor • Clinical studies now routinely shipped to S. America, India, Asia Pacific, China • An increasing proportion of temperature-sensitive products – data loggers, validated shipping systems • Supply chain more frequently includes distribution hubs • Poor transport infrastructure can be a challenge with more frequent temperature excursions • Local regulatory/ logistics knowledge is key to success

The Organisation for Professionals in Regulatory Affairs

28

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