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. Increased effectiveness and efficiencies in meeting the operational expectations of ambiguous regulations/guidances.
