IQVIA™ Real-World Insights Bibliography

. Lessons learned on the design and the conduct of Post-Auhorization Safety Studies: Review of 3 years of Pharmacovigilance Risk Assessment Committee (PRAC) oversight.
Author(s): Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn, Dreyer NA.
Affiliations(s): 
Publication(s):  British Journal of Clinical Pharmacology
Document Type(s): Article,
Countries: 
C:
Y:
Risk Management & REMS,
2017
  L:
A:
English
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Evaluation of the effectiveness of risk minimisation measures: a survey among health care professionals to assess their knowledge and attitudes on prescribing conditions of Instanyl® in France and the Netherlands.
Author(s): Toussi M1, Garofano A1, Jouaville L1, Bardoulat I1, Mitrofan L1
Affiliations(s): 1 QuintilesIMS, La Défense, France
Publication(s):  33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 2017, August 26-30, Montreal, Canada
Document Type(s): Poster,
Countries: France, Netherlands,
C:
Y:
Drug safety, Pain, Risk Management & REMS,
2017
  L:
A:
English
Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Public Health, Survey research,
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Risk Management in Pharmacoepidemiology
Author(s): Blackburn SCF.
Affiliations(s): 
Publication(s):  Risk Management in Pharmacoepidemiology, 5th edition. Edited Strom, Kimmel & Hennessy 2012 Wiley Blackwell
Document Type(s): Book chapter,
Countries: 
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Y:
Risk Management & REMS,
2012
  L:
A:
English
RWLPR (Real-World Late Phase Research-quintiles,
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Risk minimisation activities of centrally authorised products in the european union: A descriptive study
Author(s): Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, Blackburn SCF, Sturkenboom MCJM, Straus SMJM
Affiliations(s): 
Publication(s):  Pharmacoepidemiology and Drug Saf. 2011; 20:S228-S9
Document Type(s): Abstract,
Countries: 
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Y:
Risk Management & REMS,
2011
  L:
A:
English
RWLPR (Real-World Late Phase Research-quintiles,
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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,
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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: 
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Risk Management & REMS,
2008
  L:
A:
English
RWLPR (Real-World Late Phase Research-quintiles,
  Add to report
 
 
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,
  Add to report
 
 
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,
  Add to report
 
 
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,
  Add to report