Ressources



GXP quality resources  

American Society for Quality (ASQ)

http://asq.org/index.aspx


Food and Drug Agency (FDA)

http://www.fda.gov/


EU Eudravigilance

http://eudravigilance.ema.europa.eu/highres.htm


EU Medical Devices Guidelines (MEDDEV)

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm


European Forum for Good Clinical Practices (EFGCP)

http://www.efgcp.be/

 

European Medicines Agency (EMA)

http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp&jsenabled=true


European Pharmacopeia

http://www.edqm.eu/en/Work-Programme-607.html


Health Canada – Drugs and Health Products

http://hc-sc.gc.ca/dhp-mps/index-eng.php


International Conference of Harmonisation (ICH)

http://www.ich.org/


International Organization for Standardization (ISO)

http://www.iso.org/iso/home.html


Regulatory Affairs Professionals Society (RAPS)

http://www.raps.org/

 

Society of Quality Assurance (SQA)

http://www.sqa.org/


US Pharmacopeia

http://www.usp.org/


World Health Organization

http://www.who.int/en/