EMA

Clinical Trials News and Regulations

Clinical Trials News and Regulations

As we reach the end of 2020, we release our final Industry Update of the year, compiled by Christina Hägglund, QA Manager, S-cubed Ltd. This quarter, we cover the latest COVID-19 Guidance and BREXIT news. You can download a pdf…
Clinical Trials News from around the Globe

Clinical Trials News from around the Globe

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 Updated Guidance on Nitrosamines Impurities

EMA Publishes Updated Guidance on Nitrosamines Impurities

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…
Marketing Authorisation Holder GMP-related Responsibilities

Marketing Authorisation Holder GMP-related Responsibilities

Our Regulatory Affairs team have produced this article with the aim of summarising the key elements of the EMA Reflection Paper and the GMP-related responsibilities that apply to Marketing Authorisation Holders. The article also aims to assist our clients in…
Clinical Development Practices & Regulations

Clinical Development Practices & Regulations

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…