Bruno Speder, SGS Life Sciences, gives an overview of new EU regulation 536/2014, introduced to provide a single European submission and approval procedure for clinical trials, and discusses the effects it may have on early phase clinical trials
Dr Rajendra Wable, subject matter expert-medical writing and regulatory affairs at Sciformix Corporation, discusses how marketing authorisation applications across Europe, Australia and other countries can be supported with non-clinical overviews
Dr Prashanth BSB, head of safety and medical writing for ELC Group, talks to EPM about the ramifications Brexit may have on the pharmacovigilance landscape.
As pharma anticipates the forthcoming Brexit negotiations and future uncertainty, Stephie Castling, senior marketing executive from Denny Bros, examines the regulatory concerns coming to the fore in the industry.
A recently published report, sponsored by Novartis, has described the potential benefits of the NHS only paying for drugs that actually work as a new model to address affordability and reduce risks within the health system.
Narasimharaju SN, senior manager — regulatory affairs and Mac Kella, senior regulatory affairs executive at ELC Group assess whether biosimilars are really interchangeable in the EU.
Companies are putting themselves at risk by failing to appropriately prioritise and resource compliance. Here, specialist risk consultancy, Control Risks, discusses its annual research report into business attitudes towards legal and compliance risk.
The UK’s separation from the EU could have implications for regulatory harmonisation, and increase administrative workloads at a time when responsible teams are already overstretched and experienced talent is hard to find.
John Culkin, director of information management, Crown Records Management, reveals why pharma companies should still prepare for the EU GDPR regardless of Brexit.
We’ve created our very own 12 days of Christmas for the life science sector. Medical Plastics News, Digital Health Age and European Pharmaceutical Manufacturer put a festive feel on the news in 2016.
