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Interpretation of Guidances & Regulations

Rationale

Historically, pharmacovigilance has been viewed as a time-consuming challenge, suffering from confusion and misalignment on industry approaches regarding regulations, as well as divergence in regulations across global health authorities.

The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of pharmacovigilance requirements that seem ambiguous. The initial focus will be recent measures such as the IND safety reporting requirements, but over time the Initiative hopes to work proactively with health authorities toward modernized and internationally harmonized pharmacovigilance.

Benefits

This Initiative will benefit patients, sponsors, and regulators through:

  • Improved patient safety from a more reliable interpretation of regulations
  • Reduced sponsor compliance risks by better understanding of regulations
  • Increased efficiencies for regulators because of potential reductions in compliance issues

Available Assets

This Initiative will deliver the following assets and activities:

  • Interpretation and implementation best practices catalog for the IND Safety Reporting Regulations
  • Framework and process for interpreting and implementing regulations that promote collaboration with and across regulators
  • Outreach to regulators regarding initiative intent and interpretation of selected pharmacovigilance regulation

For more information about the Interpretation of Pharmacovigilance Guidances & Regulations Initiative, click here to access our overview.

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