Clinical Quality Compliance & Risk Management Conference: Speaker Interview
Christina N. DeLuca
Associate Director, GCP Inspections Lead
MERCK
Christina will be one of the distinguished speakers at the Pharmaceutical Clinical Quality Compliance & Risk Management Conference.
Why is the Clinical Quality Compliance & Risk Management Conference important for CQA executives?
This conference is important to all attendees as this industry is always evolving and it is important to stay up to date, learn from each other’s experiences, and take what we learn back to our daily responsibilities and enhance and evolve business processes accordingly. There is always something new to learn!
What is one thing you hope to learn or discuss with your peers at this conference?
I hope to discuss different inspection experiences and methods used by their companies during health authority inspections as we all have so much to share and learn from each other.
What clinical quality initiatives are on the horizon for your team in 2018?
If you were able to ask FDA one question regarding Clinical Quality, what would it be?
How has your team developed stronger partnerships with CROs?
My organization has developed a preferred partner model, in which we work with 2-3 specific CROs only, and this allows us to develop a stronger relationship and model for all clinical trials.
How do you see risk-based frameworks changing clinical quality practices in the future?
I believe it will :1) change the ways inspections are conducted by Health Authorities. 2) it will allow teams to focus on the areas of a clinical trial/program that require more attention and if utilized correctly it can effectively improve the quality of trials and data submitted for analyses.
