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PDA Ireland Chapter: ATMPs: Cell, Gene and Tissue Therapies

Sep 18, 2020
Dublin, IE

Quality Concerns, Manufacturing Challenges and Regulatory Landscape

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    • 08:00 am Registration and Complimentary Breakfast
    • 08:30 am Welcome and Introduction Ann McGee, President Ireland PDA Chapter
    • 08:40 am Keynote Address Matt Moran, Director, BioPharmaChem Ireland
    • Session I: ATMPs – A new Horizon Moderator: Valerie Mulholland, GMP Services
    • 09:00 am ATMPs: Impact on Patients and our Industry, Thurloch O’Criodain, Principal Consultant, TOC Consulting
    • 09:40 am ATMPs: A Regulatory Perspective Andrew Hopkins, Director of Compliance, Abbvie (former MHRA Inspector)
    • 10:20 am Coffee Break and Visit Exhibitors
    • 10:35 am Getting Novel Therapies to Patients, Paula Salmikangas, Director of Biopharmaceuticals and ATMP, NDA Group AB (Formerly worked with the EMA for 10 yrs)
    • 11:15 am Challenges and opportunities (with a CMC focus) in the development of an ATMP, Zabin Younes, Director Regulatory Affairs, PharmaLex UK Services Ltd.
    • 11:45 am Q&A for Session I
    • 12:05 pm Round Table Discussions
    • 12:45 pm Lunch Break and Visit Exhibitors
    • Session II: ATMPs Quality and Operations Moderator: Valerie Mulholland, GMP Services
    • 13:45 pm Meeting the Quality Challenges for ATMPs, Frank Hallinan, Biopharmaceutical & Advanced Therapies Consultant
    • 14:20 pm ATMPs: From Facility Design to Commercialisation, Hugh McMahon, Principal Consultant/QP, Commissioning Agents Inc.
    • 14:50 pm Coffee Break and Visit Exhibitors
    • 15:10 pm Key Learnings in Introducing ATMPs at a Contractor Facility, Donna McKenna, Consultant, Orphan Drug Consulting Ltd.
    • 15:50 pm Q&A for Session II
    • 16:10 pm Closing Comments Ann McGee, President Ireland PDA Chapters


The Crowne Plaza, Blanchardstown

Blanchardstown Town Centre
Dublin, IE


Registration Fees

Regular Price
Registration Type Price By Sept 18th
PDA Member €250.00 (plus booking fee)
PDA Non-Member €300.00 (plus booking fee)

Optional Complimentary Networking Event: There will also be a complimentary networking event the previous evening, Sept 18th 7:30 pm - 9:00 pm

To register your attendance for the networking event please email Elizabeth Hunt.


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