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FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward. “Like most organizations around the [...]

2021-05-06T20:40:57+00:0006.05.2021|Quality System and Audit, Regulatory Affairs|

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

The U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness. As part of our regulatory processes for reviewing all [...]

2021-04-26T20:32:08+00:0026.04.2021|Quality System and Audit, Regulatory Affairs|

Pharmacovigilance Specialist based in 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 [...]

Pharmacovigilance Specialist based in 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 [...]

Pharmacovigilance Specialist based in 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 [...]

EMA: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. New manufacturing site for AstraZeneca’s COVID-19 vaccine A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring [...]

2021-03-31T09:40:40+00:0031.03.2021|Quality System and Audit, Regulatory Affairs|

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. “Today’s [...]

Pharmacovigilance Specialist based in 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 [...]

Pharmacovigilance Specialist based in 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 [...]

Pharmacovigilance Specialist based in 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 [...]

Pharmacovigilance Specialist

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 [...]

Infarmed: Normas para logística, distribuição e utilização das vacinas contra a COVID-19

Tendo sido autorizada a introdução no mercado europeu da vacina Comirnaty, a 21 de dezembro de 2020, e podendo dar-se início à campanha de vacinação após a sua receção em território nacional, torna-se premente a divulgação das normas a serem aplicadas à logística, distribuição e utilização das referidas vacinas. As vacinas são recebidas em Portugal num [...]

2020-12-30T11:12:12+00:0030.12.2020|Quality System and Audit, Regulatory Affairs|

UK MHRA: Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC

The National Institute for Biological Standards and Control will carry out independent testing in the UK for any potential COVID-19 vaccines. As is the case for current, licensed vaccines, the quality of each batch of any potential COVID-19 vaccine will be evaluated by an independent laboratory. The independent laboratory will also carry out a thorough [...]

2020-12-29T10:37:53+00:0029.12.2020|Quality System and Audit, Regulatory Affairs|

FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D. For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of [...]

Infarmed: EMA publica orientações sobre flexibilização quanto à informação do medicamento (Folheto Informativo e Rotulagem) para as vacinas contra a COVID-19

No âmbito das medidas de flexibilidade quanto à rotulagem e embalagem das vacinas contra a COVID-19, o Infarmed informa que a Agência Europeia de Medicamentos (EMA na sigla em inglês) publicou o documento Questions and answers on labelling flexibilities for COVID19 vaccines , com orientações sobre a forma como poderá ser agilizado o desenvolvimento das vacinas no [...]

2020-12-09T20:39:51+00:0009.12.2020|Quality System and Audit, Regulatory Affairs|

FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities

Recently, leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) signed a Memorandum of Understanding (MOU) to stop harmful products that pose a threat to public health and attempt to enter the U.S. through International Mail Facilities (IMFs). [...]

2020-11-04T21:07:01+00:0004.11.2020|Quality System and Audit, Regulatory Affairs|

Infarmed: Novo Sistema de Informação para Dispositivos Médicos (SIDM)

Com o objetivo de garantir que os dispositivos médicos (DM) existentes no mercado nacional respeitam os requisitos regulamentares de qualidade, segurança e desempenho, assegurando assim os mais elevados níveis de segurança e proteção da Saúde Pública, o sistema de informação existente foi revisto de forma a otimizar a gestão de informação relacionada com DM, agilizando [...]

2020-10-24T16:21:35+00:0024.10.2020|Quality System and Audit, Regulatory Affairs|

(Cas) La AEMPS actualiza la información para los Titulares de Autorizaciones de Comercialización de medicamentos de uso humano, autorizados por procedimiento nacional (incluyendo PRM/PDC) en relación con el art. 5(3) del Reglamento (CE) N° 726/2004

Sorry, this entry is only available in European Spanish. 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. Con fecha 06 de agosto de 2020, la Agencia Europea de Medicamentos (en adelante, EMA) y el Grupo Europeo de Coordinación [...]

2020-09-25T13:23:15+00:0025.09.2020|Quality System and Audit, Regulatory Affairs|

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people [...]

2020-09-07T21:38:35+00:0007.09.2020|Quality System and Audit, Regulatory Affairs|