Webinar: Enabling the use of regulatory reliance in the Americas

Webinar: Enabling the use of regulatory reliance in the Americas
Medicine warehouse

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.

Audience

PANDRH Members and related actors from the public and private sectors involved in advancing regulatory efficiencies through convergence, harmonization, and reliance.

Agenda


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.


SESSION 2: Challenges and Opportunities for Increasing 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)

VIDEOS


Regulatory Reliance Mechanism

Value of regulatory reliance in promoting a more efficient approach to regulation of medical products. Maria Baca Estrada, Manager, Clinical Evaluation Division: COVID, Center for Vaccines, Clinical Trials and Biostatistics, Health Canada. Date. Nov 17, 2022

WEBINAR RECORDING