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European Union pharmacovigilance capabilities: potential for the new legislation.
Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802.
Ther Adv Drug Saf. 2015.
PMID: 26301067
Free PMC article.
Review.
Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
Borg JJ, Aislaitner G, Pirozynski M, Mifsud S.
Borg JJ, et al. Among authors: aislaitner g.
Drug Saf. 2011 Mar 1;34(3):187-97. doi: 10.2165/11586620-000000000-00000.
Drug Saf. 2011.
PMID: 21332243
Review.
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Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.
Borg JJ, Tomasi P, Pani L, Aislaitner G, Pirozynski M, Leufkens H, Melchiorri D.
Borg JJ, et al. Among authors: aislaitner g.
Sci Pharm. 2014 May 22;82(4):847-56. doi: 10.3797/scipharm.1312-10. Print 2014 Oct-Dec.
Sci Pharm. 2014.
PMID: 26171329
Free PMC article.
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Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.
Borg JJ, Robert JL, Wade G, Aislaitner G, Pirozynski M, Abadie E, Salmonson T, Vella Bonanno P.
Borg JJ, et al. Among authors: aislaitner g.
J Pharm Pharm Sci. 2009;12(2):181-98. doi: 10.18433/j3fw2q.
J Pharm Pharm Sci. 2009.
PMID: 19732496
Free article.
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