Dr.
Sidney Kahn is President of Pharmacovigilance &
Risk Management Inc., a consulting company he established
in 2002. Sidney has been at the forefront of US and
international developments in pharmacovigilance, risk
assessment, and risk management for the past decade.
He holds a medical degree from the University of Cape
Town, a Ph.D. from the University of London, and specialist
certification in Chemical Pathology (Clinical Biochemistry)
by the Royal College of Pathologists, London. He is
a member of the Faculty of Pharmaceutical Medicine
of the Royal College of Physicians, U.K. After 17
years in academic laboratory medicine directing large
hospital laboratories and conducting basic research
in neuroimmunology in the UK and USA, he joined the
pharmaceutical industry in 1990 and began working
on safety assessment of medicinal products throughout
their life cycle.
In
addition to his quotidian pharmacovigilance responsibilities,
he participated actively in US and international pharmacovigilance
groups, including:
· chairing the Terminology Subcommittee of
the PhRMA Committee on Clinical Safety
· representing PhRMA on the ICH M1 Expert Working
Group on Medical Terminology, which developed MedDRA®
· representing PhRMA on the MedDRA® MSSO
evaluation panel
· representing PhRMA on the MedDRA® Term
Selection Points To Consider working group
· representing PhRMA on the ICH V1 EWG established
in February 2002
· representing PhRMA on the National Coordinating
Council for Medication Error Reporting and Prevention
· membership of the Leadership Team of the
PhRMA Safety, Epidemiology & Post-Marketing Surveillance
Technical Group (formerly Committee on Clinical Safety).
He is currently a member of the CIOMS VI working group
on clinical trial safety assessment and DIA SIACs
for Terminology Management, Clinical Safety and Pharmacovigilance,
and Labeling.
In
his last pharmaceutical industry position, he managed
a large group of physicians and scientists responsible
for the safety assessment of investigational and marketed
products and personally developed innovative approaches
to signal detection and evaluation and risk management
plans for developmental and newly marketed products.
He
has given many presentations on various aspects of
pharmacovigilance, including:
· implementation and application of MedDRA®,
including both medical and regulatory perspectives
· optimization of safety labeling
· implications for pharmaceutical companies
of evolving regulatory and other international developments
in pharmacovigilance and risk management.
