PDA Ireland: ICH Q12 Webinar - A Review of ICH Q12 from a Process, Quality, Compliance and Regulatory Perspective
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Individual Registration
Group Registration
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
Agenda
Discover What's Happening Each Day
- 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
Location and Travel
Venue Details and Accommodations
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.
Registration
Pricing Options
Standard Registration
Member Price
€200.00+ €Plus FeeNon-Member
€250.00+ € Plus Fee
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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