Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 2: Clinical Trials Information System - This part of the series is about the Clinical...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 1: Transitional period and timeline Do you wonder when you need to apply the new rules...more
On May 19, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1),” updating 2010 guidance of the same name. The revised...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and Medical Devices (BfArM) and...more