CMC Strategy Forum Latin America 2021 - ENGLISH

Aug 11, 2021 10:30am ‐ Aug 11, 2021 2:00pm

CMC Strategy Forum Latin America 2021 - SPANISH

Aug 11, 2021 10:30am ‐ Aug 11, 2021 2:00pm

Business Continuity During and After the Pandemic: What Lessons Can Be Taken to the Future? - ENGLISH

Aug 12, 2021 10:30am ‐ Aug 12, 2021 1:40pm

The ongoing COVID-19 pandemic poses challenges to all National Regulatory Authorities (NRAs) and industry in the short, medium and long term. In LATAM, where there are differing capacities, resources and infrastructure across NRAs, several potential challenges and issues impact regulatory processes in different levels. Many solutions were already applied by some NRAs to minimize the pandemic impacts, avoid shortages and maintain business continuity, as the use of expedited pathways, reliance procedures, local quality control exemption for imported products and different digital solutions, such as virtual meetings, virtual inspections, e-CPP, e-GMP, e-labeling and electronic submissions. Some important lessons can be taken by this unprecedented situation, which may provide an opportunity for Regulators and Industry to strengthen their regulatory systems and implement the Best Regulatory Practices in a long term.


Business Continuity During and After the Pandemic: What Lessons Can Be Taken to the Future? - SPANISH

Aug 12, 2021 10:30am ‐ Aug 12, 2021 1:40pm