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PDA Ireland: Delivering Value and Resilience Using Quality Risk Management (ICH Q9)

Sep 08, 2022
Dublin, Ireland

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Overview

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 riskbased decision making, formality, subjectivity and supply chain management.

PRST TUDublin and PDA Ireland are hosting a joint one-day seminar on Sept 8th 2022 at TUDublin, Ireland exploring advances in Risk Management theory and practice related to pharmaceutical manufacture and supply. Academic, regulatory and industry leaders will share experiences, current concepts, opportunities and challenges, thus advancing research and sustainable enhancements to QRM practices for the benefit of patients.

Learning Benefits

  • Gain a deeper understanding of research, interpretation and application of QRM from a Process, Quality, Operations and Supply Chain Perspective.
  • Explore the impact of ICH Q9 R1 on QRM approaches across the product lifecycle and supply chain
  • Compounding
  • Hear from public health, regulatory, academic and industry experts regarding Q9 R1 key changes.
  • Participate in working sessions with invited experts on application of Q9 (R1) to real world scenarios.

Who should attend?

The following individuals or disciplines will benefit from attending this event:
  • Quality Unit (QA & QC) personnel
  • Qualified Persons
  • Compounding
  • Operations personnel (Late Phase to Commercial)
  • Technical Services, Engineering & Pharmaceutical Scientists Quality Risk Management Experts Management with responsibility for risk management

Agenda

  • Session 1: Advancing Quality Risk Management for patient benefit through research, experience and ICH Q9 revision. Public Health, Regulatory Authority, Industry and Academic leaders will share experiences, current concepts, opportunities and challenges of risk management, drawing on experience during the pandemic and from 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.

TU Dublin Grangegorman

Travel

Grangegorman Lower, D07 H6K8 Dublin 7
Dublin, Ireland

Directions

Registration Fees

Regular Price
Registration Type Price
PDA Member €250.00
Non-member €300.00

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