Regulatory Agencies across the world have quickly responded to the COVID-19 pandemic. Your approach to ongoing and new clinical trials and regulatory filing during COVID-19 requires adaptation and new strategies, such as following recommendations and using the fast-track COVID-19 programs recently instituted by Regulatory Agencies. In this white paper, we will focus on the reactions and programs put in place by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) and considerations for submissions to these Agencies.
At Certara, we accelerate medicines
to patients, partnering with life science innovators. Together with our
partners, we use biosimulation and technology-enabled services to transform
drug discovery and development. For more information visit www.certara.com or