2 results match your criteria: "Clinical Studies and Manufacturing Task Force[Affiliation]"
Shaping EU medicines regulation in the post COVID-19 era.
Lancet Reg Health Eur
October 2021
European Medicines Agency, Head of Stakeholders and Communication Division, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands.
The EU Medicines Regulatory Network (EMRN), comprised of the European Medicines Agency (EMA), the medicines regulatory authorities of the Member States and the European Commission (EC), is operating amid a complex crisis that has positioned regulators centre stage due to their key role in the development, approval and safety monitoring of vaccines and treatments for COVID-19. Here we consider the EMA's and EMRN's response to the pandemic and some of the early learnings that will help reshape medicines regulation in the post COVID-19 era. We also reflect on how some of these learnings will be formally followed up under revised EU legislation to extend EMA's mandate, reinforcing its role in crisis preparedness and response.
View Article and Find Full Text PDFAntimicrobial multidrug resistance in the era of COVID-19: a forgotten plight?
Antimicrob Resist Infect Control
January 2021
Biological Health Threats and Vaccines Strategy, Clinical Studies and Manufacturing Task Force, European Medicines Agency, 1083 HS, Amsterdam, The Netherlands.
Background: Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID-19 pandemic may further contribute. With resources deployed away from antimicrobial stewardship, evidence of substantial pre-emptive antibiotic use in COVID-19 patients and indirectly, with deteriorating economic conditions fuelling poverty potentially impacting on levels of resistance, AMR threat remains significant.
Main Body: In this paper, main AMR countermeasures are revisited and priorities to tackle the issue are re-iterated.