PDA Ireland: ICH Q12 Webinar - A Review of ICH Q12 from a Process, Quality, Compliance and Regulatory Perspective

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On behalf of the PDA Ireland, we would like to invite you to a ICH Q12 conversation on, 14 April!

A review of ICH Q12 from a Process, Quality, Compliance & Regulatory Perspective, with a focus on existing commercial operations.

ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, is a transformative document that will shape global regulatory submissions and practices. Adopted in November 2019, it has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the definition of a pharmaceutical or biological product, as well as both new molecular entities and authorized products.

Learning Benefits

  • Gain a deeper understanding of ICH Q12 from a Process, Quality, Compliance and Regulatory Perspective
  • This event will focus on the impact of ICH Q12 on current commercial products and operations
  • Hear from HPRA regarding effectiveness of the PQS, especially in relation to change management
  • Case study on the FDA Pilot program –a global Pharma company will discuss the Impact and benefits
  • Participate in a panel discussion with the invited experts via Q&A

Who should attend

The following individuals or disciplines will benefit from attending this Webinar:

  • QA & QC personnel
  • Qualified Persons
  • Quality Compliance
  • Regulatory Affairs Professionals & CMC personnel
  • Late Phase to Commercial operations personnel
  • Manufacturing personnel
  • Technical Services & Pharmaceutical Scientists

Contact

Chapter Inquiries
Membership Services

Standard Pricing

Standard Member Price

€200.00+ €Plus Fee

Non-Member

€250.00+ € Plus Fee

See Qualifying Criteria for Member Types.

Day 1

  • 14:00 (GMT) | Welcome and Introduction
    Moderator: Connie Leech, Global Director Quality, Compliance & Regulatory Service, CAI
  • 14:02 (GMT) | Welcome from PDA Ireland Chapter President
    Aidan Harrington, President, PDA Ireland Chapter
  • 14:05 (GMT) | Setting the Scene: Where are we with ICH Q12?
    Graham Cook, Sr. Director, Pricess Knowledge/Quality by Design, Pfizer
  • 14:30 (GMT) | Quality Focus: One Voice of Quality Initiative: Using ICHQ12 to Streamline Post Approval Change Processes
    Niraj Mehta, Executive Director of Post-Approval Change (PAC) Management Strategy & Global Quality Lead for Strategic Programs and Regulatory Intelligence team, Merck & Co.
  • 15:00 (GMT) | Sponsor Message, CAI Ask the Expert
    ICH Q12: Current Experience, and Outlook
    Alice Redmond, Chief Strategy Officer
  • 15:05 (GMT) | An ICHQ12 Case Study ICHQ12 FDA Pilot program – The Impact and Benefits of this Journey
    Alexia Gonnot Hoeffler, Consultant Scientist Regulatory Affairs, Eli Lilly
  • 15:25 (GMT) | Regulatory Focus
    Kevin O'Donnell, Market Compliance Manager, HPRA
  • 15:45 (GMT) | Q&A with Connie Leech and all speakers
  • 16:05 (GMT) | Closing by Moderator
    Connie Leech, Global Director Quality, Compliance & Regulatory Service, CAI
  • 16:10 (GMT) | Closing Comments by PDA Ireland Chapter President
    Aidan Harrington, President, PDA Ireland Chapter
  • 16:45 (GMT) | Close of Webinar
Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


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