EQAC

The composition of the European Quality Assurance Confederation (EQAC) is derived from National Quality Assurance Societies based in Europe with a focus on the European Union.

However, as the European legislation such as GCP Directives and also the OECD Guidance Documents apply across Europe representation has also been taken from Switzerland and other countries such as Croatia, Slovenia etc. where observers or contacts, having no national society, agree to pass relevant information on their countries to EQAC. These individuals have the ability to update quality assurance professionals with particular legislation relating to their country.

Whilst predominantly the confederation aims to become recognized with the European Union this confederation will also seek representation with other bodies such as; The Organisation of Economic Co-operation and Development (OECD), The World Health Organisation (WHO) and The Committee for Medicinal Products for Human Use (CHMP) etc. As legislation and guidance documents evolve it may be that the EQAC will seek representation with other governmental bodies.

The main objective is to make sure that all European countries and their quality representatives are aware of new legislation, changes in legislation, interpretations of various aspects by regulators and particularly changes in regulatory inspection status and attitude. The types of documentation that are likely to be of main interest are those that have a direct bearing on the QA operations in the good practices and, in particular, any Directives that will be forthcoming, guidance documents particularly in the clinical field and particular changes to local legislation and incorporation of documents into local law.

Whilst many of these activities may be totally specific to the country in which the documents have been generated, it will be of general interest to all European members to be aware of this situation and have the ability to make comments, or to obtain the documents accordingly.

Where applicable, it may become necessary to put together a consensus document from EQAC outlining concerns, positive and negative points relating to the documents and to have these passed to national inspectorates, national trade organisations or directly to OECD or the European Parliament as applicable.