Interpretation of Pharmacovigilance Guidances & Regulations

The Interpretation of Pharmacovigilance Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulations/guidances and Health Authority operational expectations around the world. Secondarily, the initiative will take opportunities to raise Health Authority awareness of the real-life impact of ambiguous regulations/guidelines. While addressing these aims, the initiative will consider the highest priority to be continued enhancement of patient safety.

Rationale

Historically, there have been challenges addressing ambiguous regulations/guidances and Health Authority operational expectations. Specific challenges have included one or more of the following elements:

  • Substantive ambiguities in text of regulation/guidance, which may result in, among other things, challenges in interpreting regulations/guidances
  • Divergence in regulatory requirements and expectations across global Health Authorities
  • Real world impediments to operationalizing Health Authority expectations

Benefits

Addressing these challenges will bring value to patients, sponsors and regulators. Examples of this value include:

  • Patients: Enhanced patient outcomes/safety through a better understanding and exploration of operational best practices to meet ambiguous regulations/guidances
  • Regulators: Clarification of ambiguous regulations/guidances through proactive sharing of feedback, observations, consequences, and proposed best practices with Health Authorities
  • Sponsors: Reduced compliance risks through better understanding of regulations/guidances
  • Sponsors: Increased effectiveness and efficiencies in meeting the operational expectations of ambiguous regulations/guidances

Available Solutions