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ANSM : Commission de prévention des risques (produits de santé)

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.L’ANSM publie le compte rendu de la commission de prévention des risques liés à l’utilisation de catégories de produits de santé [...]

2016-12-11T18:40:34+00:00 25.07.2013|Farmacovigilancia|

EMA / PRAC: one year of public health promotion and protection

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.“In a busy, exciting and productive first year establishing the new Pharmacovigilance Risk Assessment Committee (PRAC), the Committee has proactively grasped the opportunities [...]

2016-12-11T18:40:35+00:00 22.07.2013|Farmacovigilancia, Asuntos Regulatorios|

FDA halts clinical trial of drug Revlimid (lenalidomide) for chronic lymphocytic leukemia due to safety concerns

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The U.S. Food and Drug Administration (FDA) halted a clinical trial of the anti-cancer drug Revlimid (lenalidomide) because of significant safety [...]

2016-12-11T18:40:35+00:00 19.07.2013|Farmacovigilancia, Asuntos Regulatorios|

EMA welcomes new Head of Legal Service

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The European Medicines Agency (EMA) welcomes Stefano Marino as new Head of Legal Service. An Italian national, Mr Marino holds a law [...]

2013-08-01T18:11:42+00:00 19.07.2013|Asuntos Regulatorios|

UK MHRA GLP quality assurance statements guidance document has been revised

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The MHRA GLP guidance document on the content of GLP quality assurance statements has been revised. During routine GLP compliance monitoring inspections, [...]

2013-08-01T18:10:22+00:00 18.07.2013|Asuntos Regulatorios|

FDA permits marketing of first brain wave test to help assess children and teens for ADHD

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess [...]

2013-08-01T18:08:45+00:00 16.07.2013|Asuntos Regulatorios, Recursos|

EMA: Meeting highlights from the PRAC of 8-11 July 2013

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The PRAC – one year of public health protection and promotionThe Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year [...]

2016-12-11T18:40:35+00:00 12.07.2013|Farmacovigilancia|

FDA approves new treatment for a type of late-stage lung cancer

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) [...]

2016-12-11T18:40:35+00:00 12.07.2013|Desarrollo Estratégico de Fármacos|

UK MHRA Drug Safety Update: July 2013 (Volume 6, Issue 12)

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The monthly newsletter (Volume 6, Issue 12 (July 2013) from the Medicines and Healthcare products Regulatory Agency and its independent advisor [...]

2016-12-11T18:40:35+00:00 12.07.2013|Farmacovigilancia, Asuntos Regulatorios|

Ventes de médicaments en France : le rapport d’analyse de l’année 2012

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.L’édition 2012 du rapport d’analyse des ventes de médicaments en France met en évidence une contraction du marché pharmaceutique en valeur [...]

2016-12-11T18:40:35+00:00 10.07.2013|Recursos|

EMA creates Healthcare Professionals’ Working Party

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The European Medicines Agency has established a formal Healthcare Professionals’ Working Party (HCPWP) to further involve this group of stakeholders in [...]

2016-12-11T18:40:35+00:00 10.07.2013|Farmacovigilancia|

FDA Draft Guidance: Medical Device Reporting for Manufacturers

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.This draft guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and [...]

2013-08-01T17:49:07+00:00 09.07.2013|Asuntos Regulatorios|

L’ANSM engage une consultation publique relative à la mise à jour du guide des BPDG

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.L’ANSM engage une consultation publique relative à la mise à jour du guide des bonnes pratiques de distribution en gros (BPDG) [...]

2016-12-11T18:40:35+00:00 08.07.2013|Asuntos Regulatorios|

UK MHRA: Updates to GMP section: Risk based escalation to manage poor compliance

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The GMDP Inspectorate has recently implemented a non-statutory process to take action in response to poor compliance which does not yet [...]

2013-08-01T17:42:08+00:00 05.07.2013|Asuntos Regulatorios|

Dr Ian Hudson appointed as the UK MHRA’s new Chief Executive

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The Medicines and Healthcare Products Regulatory Agency (MHRA) today announced the appointment of Dr Ian Hudson as its Chief Executive. He [...]

2013-08-01T17:34:18+00:00 04.07.2013|Asuntos Regulatorios|

ENCePP guide on methodological standards in pharmacoepidemiology is revised

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance  (ENCePP), coordinated by the European Medicines Agency, has completed the second revision of the ENCePP guide [...]

FDA partners internationally to protect consumers from fake online pharmacies

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The Food and Drug Administration (FDA) participated last week in an international effort that took action against thousands of websites that [...]

2016-12-11T18:40:36+00:00 03.07.2013|Farmacovigilancia|