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Items: 1 to 20 of 85

1.

A 1-year cross-sectional analysis of non-interventional post-marketing study protocols submitted to the German Federal Institute for Drugs and Medical Devices (BfArM).

von Jeinsen BK, Sudhop T.

Eur J Clin Pharmacol. 2013 Jul;69(7):1453-66. doi: 10.1007/s00228-013-1482-z. Epub 2013 Mar 20.

2.
3.

[Procedures and methods of benefit assessments for medicines in Germany].

Bekkering GE, Kleijnen J.

Dtsch Med Wochenschr. 2008 Dec;133 Suppl 7:S225-46. doi: 10.1055/s-0028-1100954. Epub 2008 Nov 25. German.

PMID:
19034813
4.

Quality assurance in non-interventional studies.

Theobald K, Capan M, Herbold M, Schinzel S, Hundt F.

Ger Med Sci. 2009 Nov 9;7:Doc29. doi: 10.3205/000088. English, German.

5.

Results of a quality control on non-interventional studies.

Wörz K, Hundt F.

Ger Med Sci. 2011;9:Doc21. doi: 10.3205/000144. Epub 2011 Aug 15. English, German.

6.

Procedures and methods of benefit assessments for medicines in Germany.

Bekkering GE, Kleijnen J.

Eur J Health Econ. 2008 Nov;9 Suppl 1:5-29. doi: 10.1007/s10198-008-0122-5.

PMID:
18987905
7.
8.

Guidelines, editors, pharma and the biological paradigm shift.

Singh AR, Singh SA.

Mens Sana Monogr. 2007 Jan;5(1):27-30. doi: 10.4103/0973-1229.32176.

9.

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen D, Keil U; Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV..

BMJ. 2017 Feb 7;356:j337. doi: 10.1136/bmj.j337.

10.

[Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application].

Lauer W, Stößlein E, Brinker A, Broich K.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Dec;57(12):1355-61. doi: 10.1007/s00103-014-2058-5. German.

PMID:
25370170
11.

Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya.

Orwa JA, Keter LK, Ouko SP, Kibwage IO, Rukunga GM.

East Afr Med J. 2004 Jun;81(6):287-92.

PMID:
16167675
13.

Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

Ruppert T, Hahn M, Hundt F.

Ger Med Sci. 2012;10:Doc04. doi: 10.3205/000155. Epub 2012 Feb 7.

15.

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Regnstrom J, Koenig F, Aronsson B, Reimer T, Svendsen K, Tsigkos S, Flamion B, Eichler HG, Vamvakas S.

Eur J Clin Pharmacol. 2010 Jan;66(1):39-48. doi: 10.1007/s00228-009-0756-y. Epub 2009 Nov 20.

PMID:
19936724
17.

[Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

Renisch B, Lauer W.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Dec;57(12):1368-75. doi: 10.1007/s00103-014-2060-y. German.

PMID:
25376539
18.

Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until End 2007.

Siekmeier R, Halbauer J, Mientus W, Wetzel D.

Eur J Med Res. 2009 Dec 7;14 Suppl 4:216-26.

19.

[How to optimize the carrying out and the development of post-registration studies].

Borel T, Jouan-Flahault C; pour les membres du groupe Épidémiologie du Leem..

Therapie. 2011 Nov-Dec;66(6):469-72. doi: 10.2515/therapie/2011065. Epub 2011 Dec 21. French.

PMID:
22186071
20.

Provision of information on regulatory authorities' websites.

Vitry A, Lexchin J, Sasich L, Dupin-Spriet T, Reed T, Bertele V, Garattini S, Toop L, Hurley E.

Intern Med J. 2008 Jul;38(7):559-67. doi: 10.1111/j.1445-5994.2007.01588.x. Epub 2008 Mar 11.

PMID:
18336542

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