Christine brings over 30 years of clinical pharmacy expertise and deep regulatory knowledge to CLINIGMA^®'s pharmacovigilance operations. As Pharmacovigilance Manager, she ensures that patient safety remains paramount while supporting sponsors in meeting Patient-Focused Drug Development initiatives and regulatory requirements across all regulatory jurisdictions.

Clinical Research and GCP Excellence

• Extensive experience as Investigational Drug Service pharmacist following GCP and FDA regulatory requirements
• Lead project manager for hospital site clinical research with proven track record in sponsor-investigator liaison roles
• Active Institutional Review Board (IRB) member since 2017, bringing ethics and patient protection perspective
• Completed Duke School of Medicine Regulatory Affairs Training Program

Pharmacovigilance Specialization

• Expert in clinical assessment support for potential pharmacovigilance events
• Proven ability to formalize PV agreements with sponsors while maintaining regulatory compliance
• Specialized training in adverse drug event monitoring and pharmacovigilance reporting requirements
• Deep understanding of international regulatory landscapes and safety reporting obligations

Quality Assurance Leadership

• Developer and leader of internal Quality Assurance & Performance Improvement programs
• Expert in creating standard operating procedures, policies, and protocols for multidisciplinary teams
• Healthcare Ethics Certification from National Catholic Bioethics Center

Educational and Training Excellence

• Creator of comprehensive education presentations for clinical research staff and interviewers
• Proven trainer in PV reporting requirements and GCP compliance
• Published author in peer-reviewed journals including Hospital Pharmacy and The Linacre Quarterly
• Regular presenter at national conferences and regulatory hearings

Advanced Clinical Background

• Doctor of Pharmacy with ASHP-accredited Ambulatory Care Residency
• 25+ years in hospital clinical pharmacy including ICU and specialized services
• Expert in pharmacokinetics, drug interactions, and therapeutic monitoring
• Active member of Pharmacy and Therapeutics Committee with formulary decision experience

Regulatory Training and Certification

• Current Good Clinical Practice (GCP) certification through CITI Program
• Human Subjects Research (HSR) certification with ongoing compliance
• Licensed pharmacist in Maryland with active clinical practice
• Continuous education in evolving regulatory requirements

Christine's unique combination of clinical pharmacy expertise, regulatory knowledge, and patient safety focus ensures that CLINIGMA^®'s pharmacovigilance operations meet the highest standards. Her ability to provide expert clinical assessment of potential safety events makes her an invaluable asset for any clinical development program requiring rigorous safety oversight.

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