Pharmacovigilance and Drug Safety

Ensuring drug safety is a regulatory priority and pharmaceutical company’s overriding responsibility, both during the development of a product and during its lifetime in the marketplace. At the same time pharmaceutical companies struggle to ensure the quality of their products, regulators are crafting new requirements for manufacturers to provide strong assurances that their products are safe for patients.

Among the regulations confronting pharmaceutical companies are those issued by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the International Conference on Harmonization (ICH), and national governments including Australia, Japan and the United Kingdom.

Kaplan EduNeering works with global pharmaceutical companies to navigate the complex regulatory requirements needed to gain approval to bring a product to market and document its safety profile while on the market. Our clients rely on a library of Kaplan EduNeering courses co-written or reviewed with the FDA and powerful technologies that enable global compliance and cost-efficient program management.

Kaplan EduNeering has helped companies address clinical and post-marketing regulatory and performance requirements including:

Clinical Studies

  • Investigator and study staff training, testing, and confirmation of competency for all regulated job functions;
  • Real-time monitoring of training status to ensure compliance and proficiency;
  • Expandability for global deployment of compliance training, communications and management resources;
  • Part 11 validation and documentation required by relevant regulatory authorities;
  • Distribution, validation and audit-ready documentation of communications between study investigators, sponsors and Investigational Review Boards.

Post-Marketing

  • Training for collection, assessment and evaluation of adverse event reports;
  • System customization to enable identification of trends, development of accurate safety profiles, company-specific communications, and enterprise-wide program management;
  • Documentation compliant with relevant regulatory requirements including FDA’s Part 11 Validation;
  • Training and validation of qualification for subcontracted operations including call centers;
  • Learning materials available in more than 30 languages, enabling rapid deployment of compliance training resources across the globe;
  • Validated communications between clinical investigators, Investigational Review Boards, study sponsors and subcontractors.