31 Mar Guidance to the pharmaceutical industry during the COVID-19 pandemic_updated news
Due to the current epidemiological situation, the issue of developing and implementing additional measures to ensure the safety of participants in current and planned clinical trials, as well as consumers of medical products within the framework of post-marketing surveillance has become more relevant for the pharmaceutical industry.
In order to support pharmaceutical, biotechnological companies and CROs in the new reality, the regulatory sector and leading agencies have already published a number of guidelines of a methodological nature, such as:
– FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.
– FDA Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.
– EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic.
– ICH M1 Points to Consider Working Group and MedDRA MSSO provide Communication on Coronavirus (01-APR-2020)
ZM CRO GROUP team has reviewed and acted on the above recommendations as part of our activities and continues to monitor the publications of regulatory authorities in other interested countries and regions on a daily basis. We will keep you updated!
With respect and good health to You and your loved ones,
ZM CRO GROUP team