(Eng) FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
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 following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices [...]
(Eng) EMA: Generating high-quality evidence from registry-based studies
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 has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of [...]
(Eng) FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs
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.Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA [...]
(Eng) FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials
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 following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of [...]
(Eng) FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
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 following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug [...]
(Eng) FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance
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 following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and [...]
(Eng) FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes
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 following quote is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health “As part [...]
Técnico de Farmacovigilancia en Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Técnico de Farmacovigilancia en Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Técnico de Farmacovigilancia en Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Técnico de Farmacovigilancia en Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Técnico de Farmacovigilancia en Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Técnico de Farmacovigilancia en Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Técnico de Farmacovigilancia
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
(Eng) FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
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.Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to [...]
(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 [...]
(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 [...]
(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 [...]