EU-RMP Vs US REMS
1 6 th European Patients Rights Day The EMA Geriatric Medicines Strategy and the empowered aging patient Francesca Cerreta EMA (European Medicines Agency)
The management of adverse drug reactions I Ralph Edwards Diagnosis Procedures Management Therapy –Often no clear separation...
EU PV Modules - What are they?
GCP inspection findings andthe benefit risk balance-EMEA
bjr2
New Medicines: too early/too late? Thomas Lönngren EMEA Sweden, 3 July 2009.
Developing a RiskMAP Louis A. Morris, Ph.D. Pharmaceutical Education Associates December 10, 2004.
‘Taxonomy of Risks and Risk Assessment’ Ries de Visser (PRI – Wageningen UR) Partners: PRI, UCM, ATO, Dupont 6.5 person month Nov. ‘03 - May ‘04 BREW –
Developing a RiskMAP
OASIS-5
Francesca Cerreta EMA (European Medicines Agency)