Fundamentals of EU Regulatory Affairs%2C Fifth Edition Comparative Matrix
Marketing authorization procedures in eu
wyeth 1st Quarter Earnings Presentation
PSURs-Volume9b
EU Pharmacovigilance Legislation (EU NL) Regulatory Implementation status Overview and industry challenges April-2014 QPPV Office Global Pharmacovigilance.
Ketek, FDA Hearing, Dec. 2006 ÖM Ketek (telithromycin) Decisions and procedures in the European Union Örjan Mortimer, MD, Senior Expert, Delegate EMEA/CHMP-PhVWP.
EU Pharmacovigilance Legislation (EU NL)