by Ursula Tschorn | Nov 20, 2017
eAF is short for Electronic Application Form. Since 1 January 2016 the eAF is mandatory to use for all new Marketing Authorisation Applications, Renewals and Variations within all procedures in Europe.
by Ursula Tschorn | Aug 6, 2015
Electronic Common Technical Document eCTD The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. It was developed...
by Ursula Tschorn | Sep 4, 2015
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussel-based trade association founded in 1978 representing the research-based pharmaceutical industry operating in Europe. Through its membership of 33 national associations and 40...
by Ursula Tschorn | Jul 31, 2015
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.
by Ursula Tschorn | Jul 13, 2015
European Product Assessment Reports (EPAR)
