Quality Risk Management is a process for identifying quality-related hazards associated with a product, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the control. Effective quality risk management ensures the high quality of drug product for the patient. The FDA has been particularly active in fostering this concept - FDA’s Quality by Design (QbD) initiative emphasises building quality into a product during development rather than attempting to “test” quality into a product retrospectively.
Quality by Design (QbD) and Quality Risk Management (QRM) have become established in areas such as manufacturing which are characterised by strong process dependency and precise quality specifications for deliverables. To date, in the pharmaceutical industry, there has been less application of these principles in activities such as clinical drug development which are based on data-driven, iterative decision-making processes, complex multifactorial internal and external influences, human experience and expert judgment.
More recently, however, the application of the QRM/QdD approach has been expanding to clinical drug development as a means of enhancing work in highly regulated areas such as GCP compliance, data integrity and patient safety and protection. The natural further evolution would be to examine the potential of such a systematic risk-based approach to support other activities of clinical drug development such as decision-making, planning and contingency planning, and proactive project de-risking, where there would be obvious advantages in optimising the efficiency of clinical drug development.
The purpose of this conference is to pull together the experience of industry and regulators in the application of QRM/QbD to the entire spectrum of clinical drug development with a view to increasing the accessibility of such experience and stimulating its wider use.


Target Audience:

This conference is of interest to people with experience who will apply Quality Risk Management principles in the following areas:

Clinical/medical science
Clinical trial management/clinical operations
Data management
Drug safety
Transitional medicine
Process development
Project management/functional excellence
Quality risk management/quality assurance
Regulatory affairs
Statistics
Systems development
Project management/functional excellence

Quality risk management/quality assurance
Regulatory affairs
Statistics
Systems development


Event Code:
11113