Pharmacovigilance and Safety Plans (REMS)

Kaplan EduNeering helps companies develop and manage cost-effective, post-marketing safety programs that involve both internal and external personnel including employees, affiliates, healthcare professionals, and distributors.

For employees, affiliates and distributors, training on safety reporting obligations are easily distributed, tracked and documented via Kaplan EduNeering’s global platform.

For product-specific programs that are need to comply with FDA-regulated risk evaluation and mitigation strategies (REMS), our solutions assure the knowledge and understanding of compliance requirements by healthcare professionals prior to authorizing the shipment of drug to the patient – resulting in utmost patient safety. Kaplan EduNeering’s pharmacovigilance solutions support:

REMS and RiskMAP programs with online distribution and documentation of compliance with healthcare professionals
Drug safety training for employees and external partners
Centralized management of safety surveillance programs
Tailored programs to meet global regulatory compliance