Reliance is a critical efficiency for regulatory systems that can be used across various regulatory functions in pre- and post-market stages. It helps reduce workload so that resources can be prioritized elsewhere in all regulatory systems, regardless of their size and/or existing resources. The practice of regulatory reliance is encouraged by PAHO and PANDRH, following current guidelines1 and principles. Despite the recent progress made by several National Regulatory Authorities (NRAs) in adopting reliance mechanisms, there are still opportunities for further strengthening this practice. This webinar aims to identify those opportunities, discuss major remaining obstacles, and recommend a path forward to expand the use of reliance. The PANDRH’s Technical Secretariat is pleased to host this event, seeking to promote the exchange of information and experiences towards greater regulatory convergence in the Region.
PANDRH Members and related actors from the public and private sectors involved in advancing regulatory efficiencies through convergence, harmonization, and reliance.
Opening remarks and PANDRH updates. James Fitzgerald, Director, Health Systems and Services, PAHO/WHO
SESSION 1: Adoption of Regulatory reliance mechanisms in the Region of the Americas
Objective: Discuss the context and value of regulatory reliance in promoting a more efficient approach to the regulation of medical products; review lessons learned from National Regulatory Authorities of Regional Reference and other organizations on inter-institutional collaboration towards the adoption and implementation of reliance mechanisms.
Principles of an effective regulatory reliance. Maria Luz Pombo. Advisor, Vaccines and Biotechnological Products, Health Systems and Services, PAHO/WHO
The role of NRAr in the advancement of reliance: Lessons learned. Patricia Oliveira Pereira Tagliari, Associate Director. ANVISA/Brazil
Promoting collaboration to enable information sharing between authorities. Richard Siggers, Acting Manager, Bacterial and Combination Vaccines, Health Canada
Case study: Reliance pilot to improve management of Post-approval Changes (PAC) during the lifecycle of a vaccine. Thierry Gastineau, Global Head, Quality Innovation, Culture Engagement, Vaccines, Sanofi
SESSION 2: Challenges and opportunities for increased use of reliance
Objective: Reflect on challenges and opportunities to enable the effective use of reliance throughout the product life cycle and the role that regulated parties and other stakeholders in the system can play in achieving an efficient regulatory environment.
Closing remarks: Main takeaways and next steps PANDRH Secretariat Host/s
More information about The Pan American Network for Drug Regulatory Harmonization (PANDRH)
Regulatory System Strengthening in the Americas. Lessons Learned from the National Regulatory Authorities of Regional Reference (2021)
Regulatory reliance principles: concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018). PANDRH 2019 (PAHO/HSS/19-003)
Value of regulatory reliance in promoting a more efficient approach to regulating medical products. Maria Baca Estrada, Manager, Clinical Evaluation Division: COVID, Center for Vaccines, Clinical Trials and Biostatistics, Health Canada. Date. Nov 17, 2022