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(Eng) EMA: Detailed guidance on ICSRs in the context of COVID-19

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 detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal [...]

2020-04-26T17:41:52+00:0026.04.2020|Asuntos Regulatorios, Formación|

(Eng) EMA: Update to guidance on regulatory expectations in the context of COVID-19 pandemic

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 Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on [...]

2020-04-26T11:36:10+00:0026.04.2020|Asuntos Regulatorios, Formación|

(Eng) EMA: Guidance on regulatory requirements in the context of the COVID-19 pandemic

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 Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory [...]

2020-04-12T16:15:29+00:0012.04.2020|Asuntos Regulatorios, Formación|

(Eng) EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

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), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a [...]

2020-03-31T22:37:57+00:0031.03.2020|Asuntos Regulatorios, Formación|

(Eng) FDA Guidance: Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

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.FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the [...]

2020-03-25T17:39:05+00:0025.03.2020|Asuntos Regulatorios, Formación|

(Eng) UK MHRA guidance on Coronavirus (COVID-19)

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 is working closely with DHSC and other healthcare partners on COVID-19. We are prioritising work including: Supporting and authorising the development [...]

(Eng) EMA: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

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 Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to [...]

(Eng) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

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 or Agency) plays a critical role in protecting the United States from threats including emerging [...]

(Eng) FDA Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

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.Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living [...]

2020-02-04T21:07:00+00:0004.02.2020|Asuntos Regulatorios, Formación|

(Eng) FDA Guidance for Industry: Human Gene Therapy for Hemophilia

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 guidance provides recommendations to sponsors developing human gene therapy (GT) products for the treatment of hemophilia including clinical trial design [...]

(Eng) FDA Guidance for Industry: Human Gene Therapy for Rare Diseases

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 guidance provides recommendations to sponsors developing human gene therapy (GT)  products intended to treat a rare disease  in adult and/or [...]

(Eng) FDA Guidance for Industry: Human Gene Therapy for Retinal Disorders

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 guidance provides recommendations to sponsors developing human gene therapy (GT)  products for retinal disorders affecting adult and pediatric patients.  These [...]

(Eng) FDA Guidance for Industry: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions

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) has developed this document to describe relevant information that should be included in test report summaries, test [...]

2019-12-30T17:30:35+00:0030.12.2019|Asuntos Regulatorios, Formación|

(Eng) FDA Guidance for Industry: Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

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 technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for [...]

2019-12-30T17:25:47+00:0030.12.2019|Asuntos Regulatorios, Formación|

(Eng) FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics

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 document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications [...]

2019-12-07T11:23:08+00:0007.12.2019|Asuntos Regulatorios, Formación|

(Eng) FDA Guidance for Industry: Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

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 purpose of this guidance is to help sponsors design and conduct nonclinical studies during development of investigational enzyme replacement therapy [...]

2019-10-10T22:16:47+00:0010.10.2019|Asuntos Regulatorios, Formación|

(Eng) FDA Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

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) recognizes that the progression to digital health offers the potential for better, more efficient patient [...]

2019-10-03T21:27:05+00:0003.10.2019|Asuntos Regulatorios, Formación|

(Eng) EMA to provide guidance on avoiding nitrosamines in human medicines

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.EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in [...]