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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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Overview

More information coming soon.

Agenda

    • 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

Travel

The Crowne Plaza, Blanchardstown

Blanchardstown Town Centre
Dublin, IE

Directions

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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