| Evaluation of post-authorization safety studies in the first cohort of eu risk management plans at time of regulatory approval |
| Author(s): Giezen TJ, Mantel-Teeuwisse AK, Straus SMJM, Egberts TCG, Blackburn S, Persson I, et al |
| Affiliations(s): |
Publication(s): Drug Safety. 2009;32(12):1175-87
|
| Document Type(s): Article, |
| Countries: |
C:
Y: |
Risk Management & REMS,
2009 |
|
L:
A: |
English
RWLPR (Real-World Late Phase Research-quintiles, |
|
 |
| |
| |
| Changes in FDA?s Approach to Risk |
| Author(s): Gliklich RE, Bertagna Leavy M |
| Affiliations(s): |
Publication(s): Applied Clinical Trials 2008; 17(10):44-50
|
| Document Type(s): |
| Countries: |
C:
Y: |
Risk Management & REMS,
2008 |
|
L:
A: |
English
RWLPR (Real-World Late Phase Research-quintiles, |
|
|
| |
| |
| How will FDAAA change our approach to REMS? International Society of Pharmacoepidemiology |
| Author(s): Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M |
| Affiliations(s): |
Publication(s): Mid-Year Meeting Symposium, Boston, MA, May, 2008
|
| Document Type(s): Article, |
| Countries: |
C:
Y: |
Risk Management & REMS,
2008 |
|
L:
A: |
English
RWLPR (Real-World Late Phase Research-quintiles, |
|
|
| |
| |
| How will FDAAA change our approach to REMS? International Society of Pharmacoepidemiology |
| Author(s): Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M |
| Affiliations(s): |
Publication(s): Mid-Year Meeting Symposium, Boston, MA, May, 2008
|
| Document Type(s): Article, |
| Countries: |
C:
Y: |
Risk Management & REMS,
2008 |
|
L:
A: |
English
RWLPR (Real-World Late Phase Research-quintiles, |
|
|
| |
| |
| Risk Management in the European Union in Pharmacoepidemiology and Therapeutic Risk Management |
| Author(s): Blackburn SCF |
| Affiliations(s): |
Publication(s): 1st edition. Edited Hartzema, Tilson Chan 2008
|
| Document Type(s): Book chapter, |
| Countries: |
C:
Y: |
Risk Management & REMS,
2008 |
|
L:
A: |
English
RWLPR (Real-World Late Phase Research-quintiles, |
|
|
| |
| |
 2 of 2
|
