Data protection to take centre stage in 2021
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no […]
Tamsyn Frost (IDEA Regulatory) and Xavier Gobert (MyData-Trust) New laws and regulations present challenges to all businesses, but the way they impact clinical trials is especially complex. When the GDPR was introduced in 2018, it was designed with broad data protection in mind, but these requirements don’t apply neatly to clinical trials. The GDPR states […]