Skip to main content

Trinity College Dublin, The University of Dublin

Trinity Menu Trinity Search

QP Forum 2018 Programme

Thursday 12th April 2018

Time Activity
Morning Chair: Susan Neenan, Alexion
9.00am Welcome by Prof Anne Marie Healy, Head of School of Pharmacy & Pharmaceutical Sciences          

Quality Culture - from a company perspective & a regulators view
Neil Sheehan, Astellas
Ewan Norton, MHRA


Tech Talks - Led by Stan O'Neill, The Compliance Group/EUPS
Hugh McMahon
Susan Armijo

10.45am Tea/Coffee

Parallel Discussion Groups led by company experts
- Brexit - transition arrangements & QP status
- Virtual Company & Supply Chain - Challenges of CMO oversight
- Data Security & Business Continuity
- Combination Products - drug & device combinations
- Annex 1 changes & interpretations
- QP Decision Making: Scenarios from Barry Dodd, Brian Licken, Conor Fitzpatrick

12.45pm Light Lunch in Concourse

Chair: Brendan Griffin, UCC


Workshop feedback session - Key points from discussion groups


HPRA update - Regulation & Inspection
Greg McGurk
Paul Sexton


MAH Responsibilities & the Role of the QP
Introduced by Anne McGee, PharmaLex

4.30pm Reception in Concourse