PharmaQMtraining.eu

Links

European Commission
The Rules Governing Medicinal Products in the European Union


EMA
Scientific Guidelines for Human Medicinal Products

EU regulatory training
Pharmaqmtraining.eu


MHRA
Medicines and Healthcare products Regulatory Agency

ICH
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use


Heads of Medicines Agencies
Names and addresses of all the EU Agencies


ABPI
Association of the British Pharmaceutical Industry

BGMA
British Generic Manufacturers Association

EDQM
European Directorate for the Quality of Medicines and Healthcare

EGA
European Generic Medicines Association

EFPIA
European Federation of Pharmaceutical
Industries and Associations

European Pharmacopoeia

British Pharmacopoeia

US Pharmacopoeia

WHO

TOPRA
The Organisation for Professionals in Regulatory Affairs

The Proprietary Association of Great Britain

Package Leaflet (Patient Information Leaflet) User Testing

SMEs
User Guide for Micro, Small and Medium-sized Enterprises


eCTD
Electronic Common Technical Document


Hugh Delargy Associates Limited
EU regulatory consultancy


Pharmaceutical Quality Matters
EU regulatory consultancy



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