CASE STUDY PV Audit 1-19

Clinical R&D CASE STUDY Pharmacovigilance System Audit Provides Roadmap for Growth Overview Proven Expertise Compliance Implementation Services (CIS) was retained CIS is a consulting firm specializing in compliance in 2009 by a specialty pharmaceutical company to strategies for pharmaceutical companies. Our experts conduct an audit of its Pharmacovigilance (PV) Systems can quickly identify your exposure to compliance risks, to ensure that key PV Systems remain fully compliant help you develop a strategic plan and ensure its with relevant ICH and U.S. regulatory requirements and implementation and ongoing adherence to regulatory guidance. The Audit was prompted by organizational requirements. changes within the company over the past 18 months, and by the company’s intent to expand clinical CIS has a deep understanding in the following Clinical development activities in the near future. The PV areas: System Audit is one of several projects that CIS has • FDA Regulations conducted for this company to ensure its business • EMEA Guidance processes are aligned with relevant and current • International Committee on Harmonization (ICH) government regulations and with the company’s • EU Clinical Trial Directive current strategic intent. • OIG Compliance Guidance Scope • Good Clinical Practice (GCP) • Drug Safety CIS concentrated its PV System Audit activity on review • Good Manufacturing Practice (GMP) of ...