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.
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.
As solutions are used throughout the R&D ecosystem, TransCelerate receives feedback related to solution implementation experiences. Anyone can submit an experience through the Engage with Us page and in select cases, we share the experiences on Our Impact page in a blinded way. Below is a featured example for this initiative:
The initiative addresses the following ambiguous pharmacovigilance regulations and guidances: