ECA Foundation added to EMA List of Stakeholder Organisations
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The ECA Foundation is now listed in the European Medicines Agency's (EMA) list of eligible industry stakeholder organisations. Pre-requisite for this entry is the listing in the EU's Transparency Register - where the ECA has been registered since January 2019.
The ECA Foundation is the leading European organisation with regard to pharmaceutical Quality Assurance and GMP compliance.
The ECA Foundation is a not for profit organisation. The ECA is headed by a Foundation Board and a Trustee. The legal status is a Sheltered Foundation which is controlled by a lawyer who acts as the Trustee of the Foundation. The Trustee is responsible for the supervision of the statutes (charter) of the organisation. The official representative of the organisation is the Chair (Dr Afshin Hosseiny). Please see the ECA Foundation website for more detailed information. The ECA Foundation is the legal entity and heads a number of Interest Groups. The largest Interest Group is the European QP Association which represents more than 3.000 Qualified Persons in Europe.
With the listing the EMA confirmed that the ECA fulfills the criteria and will now be contacted for involvement on all four levels defined by the agency:
1. Inform (to enable feedback e.g. news items, Q&As, information Day);
2. Consult (via written consultation e.g. guidelines development, public consultations on deliverables);
3. Consult & Involve (based on direct interactions e.g. focus groups) and,
4. Co-operate (jointly engaging towards a common technical goal e.g. technical expert groups).
The first 2 levels of stakeholder involvement are open to all external parties/stakeholders and do not require specific eligibility criteria to be applied. On these two levels the ECA and its European QP Association have already been registered for several years and have thus been receiving information and notice of written consultations in selective areas.
The eligibility criteria for levels 3 and 4 apply where an organisation seeks direct involvement in EMA activities, i.e. where the industry stakeholder is consulted and involved directly or co-operating with the Agency in specific areas - and requires to submit written declaration/confirmation that the eligibility criteria defined are fulfilled.