FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance
The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health: “Today, the FDA issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices. When final, these guidance documents will [...]
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 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 [...]
EMA organises a second public meeting about the new COVID-19 vaccines
EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. Together with the EU medicines regulatory network, EMA has been working around the clock to bring much needed COVID-19 vaccines to EU citizens as quickly as possible, while keeping the same rigorous [...]
(Cas) La AEMPS lanza una campaña sobre las garantías de las vacunas frente a la COVID-19
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. Bajo el lema «Vacunas con garantías», el objetivo consiste en explicar a la ciudadanía por qué se ha acelerado tanto el [...]
EMA organises public meeting on COVID-19 vaccines
EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring. The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are [...]
EMA: Court of Justice upholds EMA’s approach to transparency
EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and unambiguous terms, the right of citizens for access to clinical study and toxicology reports submitted to EMA for the purpose of the granting of a marketing authorisation for human and veterinary medicinal products. “Transparency is an important feature of the Agency's operations. [...]
Infarmed: Transparência no preço dos medicamentos
Discutidas em Valletta novas formas de melhorar a transparência no mercado de medicamentos. Durante os dois últimos dias, na capital de Malta, decorreu a 8.ª reunião do Comitê Técnico de Valletta, paralelamente à Reunião Ministerial da Declaração de Valletta, onde esteve presente o Secretário de Estado Adjunto e da Saúde português, Francisco Ramos. Estes eventos [...]
EMA: Involving young people in EMA activities
New principles give a voice to patients and consumers under age 18 The European Medicines Agency (EMA) has agreed on principles for involving patients and consumers under the age of 18 in the activities of its scientific committees and working parties. Young patients and consumers can make an important contribution to EMA’s committee discussions on medicines [...]