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QP Forum 2016 Programme

Thursday 21st April 2016

Time Activity
Chairperson: Mr Paul Blunnie
9.00am Welcome by Professor Mary Meegan
School of Pharmacy & Pharmaceutical Sciences
9.05am

HPRA - Overview of Strategy 2016-2020
Dr Lorraine Nolan, Chief Executive, HPRA

9.15am GMP Manufacture of Mesenchymal Stem Cells: Therapeutic Potential
Prof. Timothy O'Brien, Director of the Regenerative Medicine Institute, NUI Galway
10.00am

Revision of Annex 16 - Introduction by Mr Paul Sexton HPRA
Implications for industry - speakers from Eli Lilly, Astellas & Alexion

11.15am Tea/Coffee
11.45am

Parallel Discussion Groups:
Qualification and Validation Workshop
Visual Inspection Workshop
Risk Assessment Workshop
CMO Supervision Discussion

1.15pm Light Lunch in Concourse
Chairperson: Mr Andrew Hall
2.00pm

Introduction to the Irish Chapter of PDA
Mr Declan Quinlan, Operations Director, MSD (Carlow)

2.05pm Data Integrity - From an Industry Perspective
Mr Bob Bulhmann, Director, Corporate Quality Assurance, Amgen USA
3.05pm Overview of recent GMP incidents, 483s and warning letters: What have we learned?
Introduced by Dr Brendan Griffin, School of Pharmacy, University College Cork
3.35pm Brief Regulatory Update by Mr Paul Sexton
Q&A with HPRA Inspectors panel
4.30pm Reception in Concourse

Click here for a printable pdf version of the programme


Last updated 11 April 2017 by School of Pharmacy & Pharmaceutical Sciences (Email).