Clinical Trials. Changes in submission process. Quality management during COVID-19 pandemic
On 27th of October, 2020 we have attended a virtual conference "Clinical Trials. Changes in submission process. Quality management during COVID-19 pandemic", organised by Media Biznes.
Director of Registration Office for Medicinal Products, Medical Devices and Biocidal Products, Mrs Ewa Ołdak, presented new requirements for studies submission according to act 536/2014. Also new approach for registration during COVID-19 was discussed.
After an interesting lecture, Mr Michał Gryz had an opportunity to present risk quality approach to study monitoring and threats during pandemic.