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

Date
August 12, 2021
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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.

Session Chairs

Speaker Image for Daniela Manzoli Bravo
Bayer S.A. – Brazil
Speaker Image for Kavita Aiyer
Seagen Inc.
Speaker Image for Maria Cecilia Tami
Genentech, a Member of the Roche Group

Session Speakers

Speaker Image for Ihatanderson Alves da Silva
ANVISA-National Health Surveillance Agency
Speaker Image for Stephan Rönninger
Amgen (Europe) GMBH, Switzerland
Speaker Image for Rebecca Lumsden
Pfizer Limited, United Kingdom - representing FIFARMA

Panel Members

Speaker Image for Patriciá Aprea
ANMAT- National Administration of Medicines, Food and Medical Technology
Speaker Image for Iris Lorena Arreola Dominguez
COFEPRIS-Federal Commission for the Protections from Sanitary Risks
Speaker Image for Miguel Angel Sare Cruz
DIGEMID-General Directorate of Medicines, Supplies and Drugs