Regulatory Affairs & Quality

Mission Statement

AIPES Regulatory Affairs Expert Group represents the member companies on current, pending and proposed pharmaceutical legislation, regulations, specific guidelines, etc.
The Expert Group plays a significant role in permanently monitoring these pending and proposed documents on both national and EU level.

If there are issues which could have an impact on our business, the group may take proactive lobbying actions to the European Parliament, the European Commission, the national and the EU competent health authorities, as relevant. The group drafts position papers and aims to influence the decision making through its contacts with the key regulatory and legislative staff.

On a regular base, it provides members with news and relevant documents issued by EU institutions and affiliated committees concerning pharmaceutical legislation and market issues. The Expert Group discusses regulatory topics of mutual interest and aims to agree common positions for responses to authorities.

Since its creation, the Regulatory Affairs Expert Group, has known a continuous growing importance and has successfully completed important lobbying actions.