Taking a Stand for Quality: Advancing Pharmaceutical Quality Leadership and Quality Risk Management

Join us for a free webinar presented by NIBRT in collaboration with TU Dublin, the Pharmaceutical Regulatory Science Team (PRST) and Quality Business Administration (QBA).

This event, chaired by Professor Anne Greene, explores how advancing Quality Business Leadership and QRM as critical capabilities can effectively deliver medicines today, tomorrow, and beyond.

This insightful webinar will commence with Dr. Janet Woodcock, Former Acting FDA Commissioner, sharing her perspective on why we must take a stand for pharmaceutical quality.

This will be followed by:

• Dr. Anders Vinther who will describe a new academic-industry initiative designed to kickstart a transition from compliance-focused quality management to Quality Business Leadership as a strategic cornerstone for pharmaceutical quality and business growth.
• Professor Kevin O’Donnell, Rapporteur for ICH Q9(R1) who will outline how the revised Q9 guidance advocates for integrating knowledge with risk in decision making
• Dr. Marty Lipa who will present the RKI cycle, a practical approach to connect Knowledge Management and Quality Risk Management

Key webinar topics:

• Developing Quality Business Leaders
• Linking Knowledge & Risk in Support of ICH Q9(R1)

Learning outcomes:

• An awareness of the need to transition from compliance-based quality to Quality Business Leadership
• An understanding of the 6 traits of QBL
• An awareness of the need to connect quality risk management and knowledge management
• An understanding of the RKI Cycle as a means to connect QRM and KM

Who should attend this webinar?

Industry, Regulatory and Academic thought leaders in the pharmaceutical sector.

Register