Delivering Value and Resilience using  Quality Risk Management

Delivering Value and Resilience using Quality Risk Management

Actions and Detail Panel

€200 – €300

Date and time

Location

TU Dublin Grangegorman

Grangegorman Lower

D07 H6K8 Dublin 7

Ireland

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A Joint Seminar and Workshop hosted by PDA Ireland and PRST TUDublin

About this event

The COVID Pandemic saw an unprecedented scale of risk management across public health and pharmaceutical sectors. The recent revision of ICH Q9 in 2021, focused on key areas n including 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.

  1. Risk management in the public health context – the COVID experience of risk-based decision-making during time of uncertainty and rapid research - Prof. Philip Nolan, Science Foundation Ireland
  2. ICH Q9: Background to Revision 1, key concepts and implementation - Kevin O’Donnell., HPRA
  3. Leveraging QRM to assure medicine supply during the pandemic - Barbara Allen, Industry Expert
  4. Clarifying the Diamonds - Decision Making in QRM and the PQS - Valerie Mulholland, PRST/GMP Services
  5. Panel Discussion and Q&A

During this afternoon session, experts will share their insights and experiences on topics such as formal versus informal risk management, QRM as an enabler to the PQS, subjectivity and knowledge management

  1. Quality Risk Management Formality - Not necessarily a Black-Tie Affair - Jim Cashman, Eli Lilly
  2. Subjectivity – The behavioural science of risk management - Nuala Calnan PRST TUDublin / QRM Institute
  3. The inter-relationship of Knowledge Management and Quality Risk Management - Marty Lipa Ph.D. PRST TUDublin/ MSD
  4. Risk management across manufacturing operations networks - Invited BMS
  5. Panel Discussion and Q&A

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 (under Add-ons).

  1. Integrating QRM & Reliability to enhance our P's - (Prevention, Prediction, Proactivity, imProvement, within Projects/Programs and oPerations) - Gary Power, MSD & Marcus O’Mahony, UL
  2. Batch Release Acceleration – Using Quality Risk Management to enable “warp speed” batch release - Richard Falcon, Pfizer & Brendan Griffin, UCC
  3. From Development to Commercialisation and during Accelerated conditions - How do we apply QRM? - Donna Leamy, Regeneron & Marty Lipa, MSD
  4. Quality Risk Management in Global Supply Chains - Ann McGee, MIAS Pharma & Nuala Calnan, TUDublin /QRM Institute

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 here:

https://www.pda.org/global-event-calendar/event-detail/pda-ireland-ich-q9#agenda

For any further information or questions, please contact: deirdre.tobin@merck.com

Thank you to our sponsors for supporting this event:

Pharmalex

SkillPad

Ecolab (Bioquell)

Elis

Novatek Europe

ERA Sciences

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