Focus on Latin America: Building quality submission and review processes and practices – Overcoming challenges and meeting expectations
23-24 January 2014, Lima, Peru
This workshop was held to discuss how agencies are building quality into their review process and to identify the challenges involved in moving from a guidance document to the use of good review practice (GRevP) in the daily workings of an agency and how this can help underpin good regulatory decisions, performance measurement, and quality. The themes of this workshop carry forward a discussion begun in 2011 by CIRS amongst agencies at a workshop in Kuala Lumpur, Malaysia and revisited this past January 2013 at a workshop in Beijing, China.
Workshop objectives
- Identify current initiatives/approaches being used by agencies in building quality review systems and the role of GRevP in decision making
- Discuss the challenges of aligning knowledge of, attitude toward and practice of GRevP within agencies as they evolve their processes and procedures
- Recommend approaches to build quality and efficiency into agency review processes and practices
- Understand the challenges faced by the pharmaceutical industry in meeting diverse agency requirements and multiple requests for information during dossier reviews