With COVID-19 dominating clinical trials news, our latest industry update includes coverage of the key guidance documents issued by the regulators and much more. Compiled by Christina Hägglund, QA Manager, S-cubed Ltd. You can download the pdf of this update…
EMA Publishes a New Question and Answer Document for Marketing Authorisation Holders on the CHMP Opinion for the Article 5(3) referral on Nitrosamine Impurities in Human Medicinal Products (EMA/409815/2020) The European Medicines Agency (EMA) have published a new ‘question and…
Clinical Development Practices and Regulations are the main focus for our Q2 Industry Update. We also include important information about COVID-19, expertly compiled by Christina Hägglund, QA Manager, S-cubed Ltd. Read all the latest regulatory news here. You can download…
S-cubed's Regulatory Affairs team compiles the latest updates from the European Medicines Agency to the COVID-19 pandemic. The European Medicines Agency (EMA) continues to update guidance and procedures in response to the COVID-19 pandemic, including measures being put in place…
UPDATE: Latest news from MHRA The deadline for provision of the step 1 responses has been extended for an additional 6 months to 1 October 2020. This deadline is subject to review in light of the ongoing Coronavirus (COVID-19) outbreak…
