Advertisement

Drug Safety

, Volume 42, Issue 11, pp 1353–1353 | Cite as

Correction to: Patient Registries: An Underused Resource for Medicines Evaluation

Operational proposals for increasing the use of patient registries in regulatory assessments
  • Patricia McGettiganEmail author
  • Carla Alonso Olmo
  • Kelly Plueschke
  • Mireia Castillon
  • Daniel Nogueras Zondag
  • Priya Bahri
  • Xavier Kurz
  • Peter G. M. Mol
Correction

1 Correction to: Drug Safety  https://doi.org/10.1007/s40264-019-00848-9

The fourth sentence under the heading “1.1 Use of Patient Registries for Supporting Regulatory Assessments” in “1 Introduction” section should read as below:

For certain products, registry studies may provide post-authorisation data to fulfil regulator-imposed obligations to confirm safety and/or effectiveness, as is the case with the recently authorised chimeric antigen receptor (CAR) T-cell products, tisagenlecleucel and axicabtagene ciloleucel [8, 9].

In addition, reference 5 should read as below:

5. European Medicines Agency. Patient Registries. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries. Accessed 25 Aug 2019.

The citation of reference “[6]” should read as “[5]” in Sects. 3, 4 and 6.

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.William Harvey Research InstituteQueen Mary University of LondonLondonUnited Kingdom
  2. 2.Pharmacovigilance and Epidemiology DepartmentEuropean Medicines AgencyAmsterdamNetherlands
  3. 3.Department of Clinical Pharmacy and Pharmacology, University Medical Centre GroningenUniversity of GroningenGroningenThe Netherlands
  4. 4.Dutch Medicines Evaluation BoardUtrechtThe Netherlands

Personalised recommendations