Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products-Reference-Cited by-同舟云学术

Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

Published:2017-08-30 Issue:1 Volume:73 Page:64-76
ISSN:0105-4538
Container-title:Allergy
language:en
Short-container-title:Allergy

Author:

Bonertz A.¹^ORCID,Roberts G. C.²³⁴,Hoefnagel M.⁵,Timon M.⁶,Slater J. E.⁷,Rabin R. L.⁷,Bridgewater J.⁷,Pini C.⁸,Pfaar O.⁹¹⁰^ORCID,Akdis C.¹¹,Goldstein J.¹²,Poulsen L. K.¹³,van Ree R.¹⁴,Rhyner C.¹⁵,Barber D.¹⁶,Palomares O.¹⁷,Sheikh A.¹⁸,Pawankar R.¹⁹,Hamerlijnk D.²⁰,Klimek L.¹⁰,Agache I.²¹,Angier E.²²,Casale T.²³,Fernandez‐Rivas M.²⁴,Halken S.²⁵,Jutel M.²⁶,Lau S.²⁷,Pajno G.²⁸,Sturm G.²⁹³⁰,Varga E. M.³¹,Gerth van Wijk R.³²,Bonini S.³³,Muraro A.³⁴,Vieths S.¹

Affiliation:

1. Paul‐Ehrlich‐Institut Langen Germany

2. University of Southampton Southampton UK

3. University Hospital Southampton NHS Foundation Trust Southampton UK

4. David Hide Asthma and Allergy Research Centre Newport Isle of Wight UK

5. CBG‐MEB (Medicines Evaluation Board) Utrecht The Netherlands

6. Division of Biological Products, Advanced Therapies and Biotechnology Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Madrid Spain

7. US Food and Drug Administration Silver Spring MD USA

8. Istituto Superiore di Sanità Rome Italy

9. Department of Otorhinolaryngology, Head and Neck Surgery Medical Faculty Mannheim Universitätsmedizin Mannheim, Heidelberg University Mannheim Germany

10. Center for Rhinology and Allergology Wiesbaden Germany

11. Swiss Institute of Allergy and Asthma Research University Zurich Davos Switzerland

12. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda MD USA

13. Allergy Clinic Copenhagen University Hospital at Gentofte Copenhagen Denmark

14. Departments of Experimental Immunology and of Otorhinolaryngology Academic Medical Center University of Amsterdam Amsterdam The Netherlands

15. SIAF Davos Switzerland

16. Universidad CEU San Pablo Madrid Spain

17. Department of Biochemistry and Molecular Biology School of Chemistry Complutense University of Madrid (UCM) Madrid Spain

18. The University of Edinburgh Scotland UK

19. Nippon Medical School Tokyo Japan

20. Patient Advocacy Group Dutch Lung Foundation Amersfoort The Netherlands

21. Department of Allergy and Clinical Immunology Faculty of Medicine Transylvania University Brasov Brasov Romania

22. Sheffield Teaching Hospital Sheffield UK

23. University of South Florida Tampa FL USA

24. Allergy Department Hospital Clinico San Carlos, IdISSC Madrid Spain

25. Hans Christian Andersen Childrens Hospital Odense University Hospital Odense Denmark

26. Poland and ALL‐MED Medical Research Institute Wroclaw Medical University Wrocław Poland

27. Department for Pediatric Pneumology and Immunology Charité Universitätsmedizin Berlin Germany

28. Department of Pediatrics and Allergy Unit University of Messina Messina Italy

29. Department of Dermatology and Venerology Medical University of Graz Austria

30. Outpatient Allergy Clinic Reumannplatz Vienna Austria

31. Medical University of Graz Graz Austria

32. Erasmus MC Rotterdam The Netherlands

33. University of Campania Luigi Vanvitelli, IFT‐CNR Naples, Rome Italy

34. Padua University Hospital Padua Italy

Funder

European Academy of Allergy & Clinical Immunology

Publisher

Wiley

Subject

Immunology,Immunology and Allergy

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.13266

Reference41 articles.

1. The Council of the European Communities. COUNCIL DIRECTIVE of 3 May 1989 amending Directives 65/65/EEC 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law regulation or administrative action relating to proprietary medicinal products 1989: Official Journal of the European Communities.

2. The Council of the European Communities.Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines toxins or serums and allergens.1989: Official Journal of the European Communities.

3. The European Parliament and Council.Directive 2001/20/EC on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.2001: Official Journal of the European Union.

4. European Medicines Agency.EU Clinical Trials Register.https://www.clinicaltrialsregister.eu(Aug 18 2017).

5. U.S. National Institutes of Health.ClinicalTrials.gov.https://clinicaltrials.gov/(Aug 18 2017).

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