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In brief

In light of the extension of the emergency period until 31 January 2021, and in order to ensure – where possible – the continuity of trials while reducing contacts between clinical staff and patients, on September 17 the AIFA published an updated version of its Guidelines for the management of clinical trials during the COVID-19 emergency


In depth

These Guidelines, addressed to pharmaceutical companies, non-profit sponsors and CROs, introduced temporary exceptions to the in-force legal and regulatory framework, with specific regard to the following aspects:

  • submission of clinical trial applications and substantial amendments
  • methods for the adoption of opinions by Ethics Committees
  • management of clinical trial activities outside of the clinical site
  • management of investigational drugs
  • conduct of clinical analyses and/or checks that are essential for the safety of trial subjects
  • monitoring of clinical trials

Compared to the previous version dated 7 April, 2020, the new Guidelines provide further clarifications on the methods for submitting clinical trials applications and substantial amendments, introduce additional temporary means for the remote access to trial subjects’ documentation in order to ensure the monitoring of trials, and provide instructions on how to inform the competent authorities about the adoption of urgent measures involving amendments to the performance or management of clinical trials necessary to comply with COVID-related provisions.

The updated version of the Guidelines is available on the AIFA’s website.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

Author

Irene Carlet is a Law Clerk/Intern in Baker McKenzie's Rome office.