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Session 1B (CMC Track): Role of Quality Risk Management in Oligonucleotide Drug Development
Session Chair(s)
James V. McArdle, PhD
President
McArdle & Associates LLC, United States
Risk Management is the identification, assessment, prioritization, mitigation and communication of risk, which is defined as the probability of occurrence and severity of harm. Risk Management has recently become more widely adopted in the pharmaceutical industry, where it is now recognized as an integral component of an effective Quality System. Scientific advice regarding the application of Risk Management to the manufacture and use of pharmaceuticals is provided in ICH guideline: Quality Risk Management, Q9. This session will feature two presentations. The first presenter will summarize the general principles of Quality Risk Management delineated in Q9; the second presenter will discuss the specific application of some of the principles to oligonucleotide drug development. The presentations will be followed by a 30 minute panel discussion.
Speaker(s)
ICH Q9 Quality Risk Management: Perspective and Examples
H. Gregg Claycamp, PhD, MS
FDA, United States
Senior Scientist for Risk Analysis and Decision Analysis, ONADE, CVM
Applications of Risk Assessment in the Manufacturing Development Cycle
Paul Van Norman
NITTO DENKO Avecia, Inc., United States
Director, Manufacturing Operations
Paul Van Norman
NITTO DENKO Avecia, Inc., United States
Director, Manufacturing Operations
Panelist
H. Gregg Claycamp, PhD, MS
FDA, United States
Senior Scientist for Risk Analysis and Decision Analysis, ONADE, CVM
Panelist
Mohan K. Sapru, PhD, MS
FDA, United States
CMC Lead, Office of Pharmaceutical Quality, CDER
Panelist
Susann Rosmus
Biospring Gmbh, Germany
Head of QM
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