PDA Ireland: Delivering Value and Resilience Using Quality Risk Management (ICH Q9)
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The PDA Ireland Chapter proudly presents a joint seminar and workshop hosted by PDA Ireland and PRST TUDublin on Quality Risk Management (ICH Q9).
Delivering Value and Resilience using Quality Risk Management
The COVID Pandemic saw an unprecedented scale of risk management across public health and the pharmaceutical sector. In late 2021, the International Council for Harmonization of Technical Requirements for Pharmaceuticals, (ICH), released a draft revision to its guideline on Quality Risk Management (ICH Q9). Key areas addressed in the revision include risk-based decision making, formality, subjectivity, and supply chain management.
PRST TUDublin and PDA Ireland are hosting a joint one-day seminar on 08 September at TUDublin, Ireland to explore advances in Risk Management theory and practice related to pharmaceutical manufacturing and supply.
Academic, regulatory, and industry leaders will share experiences, current concepts, opportunities, and challenges in advancing research and sustainable enhancements to QRM practices for the benefit of patients.
Four concurrent workshops will take place where attendees will discuss the interpretation and application of the four new elements of ICH Q9 to real-world scenarios such as operation reliability, quality release and supply chain.
Event Location
Grangegorman Lower, D07 H6K8 Dublin 7, Dublin, Ireland Get DirectionsContact
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Membership Services
Standard Pricing
Standard Member Price
€250.00Non-Member
€300.00
Day 1
Session 1: Advancing Quality Risk Management for Patient Benefit through Research, Experience, and ICH Q9 Revision. Public health, regulatory, industry, and academic leaders will share experiences, current concepts, opportunities, and challenges in risk management, drawing on experience during the pandemic and from the Q9 revision.
Session 2: Current and Emerging Practices: Insights, Experiences, and Future State. Experts will share their insights on the areas of Q9 revision including formality, subjectivity, and supply chain during this session, and attendees will participate in Q&A exploring the open points of discussion.
Session 3: Four concurrent working sessions on interpretation and application to example scenarios. Attendees will discuss the interpretation and application of the four new elements to real-world scenarios such as operation reliability, quality release, and supply chain.
Session 4: Close out Cafe. The event will conclude with a networking session, collating the discussions and identifying areas of best practice and future research.
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.
TU Dublin Grangegorman