About this Event
The COVID Pandemic saw an unprecedented scale of risk management across public health and pharmaceutical sectors. 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. In the morning session, 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.
QRM has been an integral enabling element of the pharmaceutical quality system (PQS) since the adoption of ICH Q9. Despite it now being widely used, many uncertainties remain regarding QRM, for example, formal versus informal, enabler or QS tool. During this afternoon session, experts will share their insights and experiences on these topics and attendees will participate in a Q&A exploring the open points of discussion.
In our mid-afternoon workshops, 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. As each workshop will be run simultaneously, attendees are invited to select one workshop of their choice during the booking process. Information from all workshops will be shared in a closing networking event and also post the event.
We look forward to welcoming you.
Refer to full agenda below
For any further information or questions, please contact: [email protected]
Event Venue & Nearby Stays
TU Dublin Grangegorman, Grangegorman Lower, Dublin 7, Ireland
EUR 0.00 to EUR 300.00