All the latest regulatory updates compiled for you by S-cubed.
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EMA Publishes Updated Guidance on Nitrosamines Impurities
Latest news from EMA regarding nitrosamines
Marketing Authorisation Holder GMP-related Responsibilities
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
Clinical Development Practices & Regulations
Our latest Industry Update for Q2 covers the latest regulatory information around COVID-19 and much more.
COVID-19: European Medicines Agency Updates
Latest updates from EMA in response to the COVID-19 pandemic.
Nitrosamine Risk Evaluation for Marketing Authorisation Holders
The deadline for Nitrosamine Risk Evaluation is looming. Are you ready?
Clinical Trial Regulation, ICH E6(R2) & Brexit
Our first Industry Update of 2020 focuses on Clinical Trial Regulation, Brexit and the latest from FDA & EMA.
MAH Nitrosamine Risk Evaluation update – 1 month to go
With just one month to go, have you completed your risk evaluations? Make sure you are ready!
Simultaneous National Scientific Advice (SNSA)
The EU Pilot for 2 Member States to gain simultaneous national scientific advice is launched on 1st February. Find out more here.
Nitrosamine MAH Risk Assessment – Two Months to Go
Two Months to Go – Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities
Nitrosamines, TOPRA, Drug Development News
Nitrosamines, TOPRA, & Drug Development News are the focus for our Q4 Industry Insights
Global Harmonisation of Clinical Trials
Global Harmonisation of Clinical Trials is the latest focus for our quarterly roundup of the regulatory landscape with news from EMA, FDA and ICH