Pharmaceutical Industry Consulting
Pharmacovigilance, from pharmakon (Greek ‘medicine’) and vigilia (Latin ‘to keep watch’):
to monitor the safety of medicines and take steps to reduce their risks and increase their benefits.
Specialty: Pregnancy Registries
Development of pregnancy exposure registry programs
Registry design, operation, program evaluation
Data collection, data review, and communication
Independent Advisory Committee leadership, membership
Providing project and operational support in pharmacovigilance and drug safety surveillance, clinical risk management, aggregate reporting, and regulatory documentation.
Specialty: FDA Guidance on the Inclusion of Pregnant Women in Clinical Studies
Interpretation of the guidance
Information for IRBs