This Workshop was a follow-on from that held in 2017 in Sao Paulo entitled “Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be utilised to achieve an effective use of resources?”. The programme was reviewed and developed in discussion with the South African Health Products Regulatory Authority.
Workshop objectives
- Discuss when reliance models can and should be used (by design or default) as well as the frameworks, data and trust that need to be in place to enable effective and efficient utilisation of reliance models.
- Understand how to practically implement reliance models for decision making in the review of medicines, variations and generics and how agencies/consortia can overcome the implementation hurdles and focus on the benefits of utilising these approaches.
- Recommend practical and acceptable reliance models for evaluating new medicines, generics and variations and how to ensure the success of these as approaches to decision making that allow agencies to focus on value-added activities and provide timely patient availability to safe, effective good-quality
medicines.
