ABPI Association of British Pharmaceutical Industry
ADME Absorption, Distribution, Metabolism and Excretion
ADR Adverse Drug Reaction
AE Adverse Event
CPMP Committee for Proprietary Medicinal Products
CRF Case Report Form
CSM Committee on Safety of Medicines
CTC Clinical Trial Certificate
CTX Clinical Trial Certificate of Exemption
DBDD Double Blind Double Dummy
EMEA European Medicines Evaluation Agency
FDA Food and Drug Administration
GCP Good Clinical Practice
GMP Good Manufacturing Practice
IDB Investigators’ Drug Brochure
IEC Independent Research Ethics Committee
MAA Marketing Authorisation Approval
MHRA Medicines and Healthcare Products Regulatory Agency
MREC Main Research Ethics Committee
NCE New Chemical Entity
NICE National Institute of Clinical Excellence
P Pharmacy Only Medicine
PIL Patient Information Leaflet
POM Prescription Only Medicine
PPRS Pharmaceutical Price Regulation Scheme
PMS Post Marketing Surveillance
QA Quality Assurance
QC Quality Control
SAE Serious Adverse Advent
SDV Source Data Verification
SOP Standard Operating Procedure
SAMM Safety Assessment of Marketed Medicines
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Reading
Berkshire
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+44 (0)118 9522 799
Pharmaceutical Physicians