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Name Role Member state or<br />

affiliation<br />

Outcome<br />

restriction<br />

following<br />

evaluation of e-DoI<br />

Topics on agenda<br />

for which<br />

restrictions apply<br />

Andrew Ruddick Expert -<br />

via<br />

telephone*<br />

United Kingdom No restrictions<br />

applicable to this<br />

meeting<br />

A representative from the European Commission attended the meeting<br />

Meeting run with support from relevant EMA staff<br />

* Experts were only evaluated against the product(s) they have been invited to talk about.<br />

Full involvement<br />

Pharmacovigilance Risk Assessment Committee (PRAC)<br />

EMA/PRAC/257790/2015 Page 89/89

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