Cathy Dove is a trusted Quality & Risk Management Industry expert, an RQA GCP Committee member and Course Tutor working within Clinical Quality Compliance and Risk Management. Cathy Dove has a wealth of Pharmaceutical Clinical Research expertise and proven track record in driving awareness and visibility of quality through quality and risk management solutions in adherence to ICH GCP E6 R2.
Cathy has over 25 years Global Pharmaceutical Clinical Research expertise (Phase I-IV) both from a large International CRO as well as a blue-chip Pharma Company. She is also a Pharmacist and a member of the Royal Pharmaceutical Society GB. During her career, Cathy has held the positions of Global Head of Project Quality Management, Head of APAC Quality (based Singapore) and through her extensive auditing experience, Global Head of Quality Assurance.
So, what are Cathy’s credentials with regard to Risk Management?
- Cathy has Conceptualised, Designed and Implemented proactive Quality Management models that provide Quality and Risk visualisation at the study level.
- Defined Risk Management Strategies via Data Evaluation from 1500+ Sponsor audit and Inspections.
- Evaluated Risk Based Monitoring activity compliance against ICH GCP E6 R2 for Inspection Readiness.
- Hosted / Conducted / Trained Staff in Sponsor Audits & Inspection on Global stage
Other Areas Cathy Consults in:
- Vendor Oversight and CRO / Pharma Collaboration & Risk Management Strategy
- Regulatory Inspections & Sponsor Audits
- Complex System Audits and For Cause Audits / Investigations