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Regs & Legs

 

article

Navigating pharmacovigilance complexity in the US and EU: notes for biotechs

15 June 2021 | By ,

Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…

article

Waiving COVID-19 vaccine intellectual property rights

11 June 2021 | By

South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…

webinar

Navigating the transition from IVDD to IVDR

9 June 2021 | By Tecan

This webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.