Good practices in computational methods

Italian representatives:
Paolo Roazzi, Istituto Superiore di Sanità, Health Technology Assessment Expert in IT Security and Good Laboratory Practices
Eugenio Carrani, Istituto Superiore di Sanità, Presidency Secretariat, Expert in IT Security and Good Laboratory Practices
Olga Tcheremenskaia, Istituto Superiore di Sanità, Environment and Health Department. Expert in Computational Methods

The OECD Secretariat, in the e-mail sent on 8 December 2020, asked the Heads of National Delegations to the Chemicals and Biotechnology Committee (CBC) to nominate the experts for a new ad hoc Group. The main role of this Group is to develop a new quality assurance document on Good Computational Methods Practices (GCMP) and to ensure alignment with the existing principles of Good Laboratory Practices (GLP) in the context the "Mutual Acceptance of Data" (MAD) system.

In response to this request, a multidisciplinary internal group of experts in the fields relevant for computational methods, GLP and MAD hasbeen created at the Istituto Superiore di Sanità (ISS). The group includes three experts listed above who will participate, in form of teleconference or face to face, in the meetings at the OECD and three supporting experts Environment and Health Department: Patrizia Pelosi, expert in GLP, Cecilia Bossa, expert in computational methods and Chiara Battistelli, expert in computational methods.

The key responsibility of GCMP Group is to define a strategy on how to extend the GLP principles, which are already recognized at OECD level for experimental methods, to the computational methods in the contest of the MAD system, and on how to keep MAD up to date and flexible.
 
During the first half of 2021, the Group has actively participated in the discussions on the application of the CGMP principles to the new OECD guideline "Defined Approach (DA) for skin sensitisation", which includes computational methods and fixed data interpretation procedure. The main topic of the discussion was how the results of the DA can be covered by the agreement on MAD for different possible scenarios.

The GCMP Group is currently waiting for the future mandates from the CBC and the OECD Secretariat   on the topics regarding Good Computational Methods Practices and Mutual Acceptance of Data.