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Regulatory Roadmap for the development of human medicinal Products (Europe focus)

Just click on the various stages below to reveal the information.


Idea

DESCRIPTION Formulation of an idea or thesis to investigate a particular disease area. For pharmaceutical development purposes this should be linked to potential means of treating disease / curing disease / reducing symptoms / maintaining quality of life associated with producing a medicinal treatment.
INPUTS None
PROCESSES "Non GxP" Research
REGULATIONS

Control of Substances Hazardous to Health (COSHH)
Intellectual Property Office : Patents

GUIDANCE

Joint Research Council Guidance for non-regulated research
National Institute for Health & Clinical Excellence
Medicines Research Council
NHS research support

OUTPUTS Target Drug / Hypothesis
RQA Courses/Seminars/eLearning

Implementing Quality Systems in Research Environments

eLearning

RQA Publications

Guidelines for Quality in Non-Regulated Scientific Research

Quality Systems Workbook