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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          
9.10am

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

10.10am

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

10.45am Tea/Coffee
11.15am

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
Afternoon

Chair: Brendan Griffin, UCC

1.30pm

Workshop feedback session - Key points from discussion groups

2.00pm

HPRA update - Regulation & Inspection
Greg McGurk
Paul Sexton

3.15pm

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

4.30pm Reception in Concourse