Rosemarie Corrigan

Rosemarie is an experienced global leader in Quality, Audit, Compliance, and Quality Risk Management and provides consultancy services to pharma and Biotech. Previously she held the position of EVP Global Quality at Worldwide Clinical trials where she directed and oversaw quality and compliance programs for all areas of the Worldwide organization encompassing QMS, quality risk management, audit, training, standards and controlled documents, data integrity, audit and inspection readiness, process improvement, and quality metrics. Previously Rosemarie was the Chief Quality Officer at Nordic Nanovector, where she established the QA strategy and operations for development of radiopharmaceutical products.

Rosemarie holds a Masters in Bioethics and Medical Law from St Mary's University, London, and a Batchelor of Science in Biochemistry from University College Galway. She is eligible to be an QP for IMPs. She is a Fellow of Research Quality Assurance and Fellow of Royal Society of Biology. She is the current chair of RQA GCP committee.

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Cathy Dove

Cathy Dove is a Quality & Risk Management Industry expert, providing risk and quality management consultancy along with GCP audits and bespoke training to a range of Pharma and Biotech clients. She is an RQA GCP Committee member and member of the EFGCP Quality Working Group, working within Clinical Quality Compliance and Risk Management.

Cathy has over 30 years Global Pharmaceutical Clinical Research expertise (Phase I-IV) both from Pharma and CRO and is also a pharmacist. During her career, Cathy has held various global senior leadership positions (including 2 years based in Singapore). Her responsibilities included project quality management, internal audits across all Clinical Research Services, preparation, hosting, and follow-up of inspections from all major regulatory inspectorates and sponsor audits.

As an independent consultant Cathy continues to support clients with inspection readiness, risk and quality management projects, sponsor oversight and vendor audits, complex system and for cause site audits and bespoke training courses.

Cathy has been a course tutor for the RQA GCP Auditing Course for over 20 years and is the course principle for the Risk Management in Clinical Trials course.

Julie Kelly

Susana Tavares

Experienced Director of Research Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Strong skills as a manager and in Auditing CROs, partners, sites, systems, documental audits along several regions in preclinical, clinical and pharmacovigilance field. Also high experienced as a trainer and in quality systems among Good Clinical Practice (GCP), Good Preclinical Practices (GLP), Pharmacovigilance, Medical Affairs and corporate quality systems. Hosted a high number of FDA, EMA, Infarmed inspection for GCP, GLP and pharmacovigilance.

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