Objective and comprehensive signal work-ups and risk assessment reviews

Objective and comprehensive reviews of safety issues prior to and for presentation to FDA Advisory committees and the EMEA Pharmacovigilance Working Party.

Good Pharmacovigilance Practices (GPVP) – the conduct of intelligent and systematic pharmacovigilance, with technology enabling.

Good Postmarketing Surveillance Practices (GPMSP) – the organization and conduct of systematic postmarketing surveillance in compliance with global regulatory standards and requirements, including a Risk Management strategy.

The rational use of pharmacoepidemiology in GPMSP

Both Corporate and Public Health Risk Management Strategies and their Implementation.

Drug Safety Process re-engineering: RCN has led BPR efforts in major pharmaceutical companies, in association with some of the major global consulting firms.

Periodic Safety Update Report (PSUR) -centric postmarketing safety program management

Forensic and regulatory epidemiology

Drug Safety: Premarketing

Regulatory Affairs