EMA Features eSignature Workshops
EMA webminars on eSignatures
The European Medicines Agency (EMA) has announced it is hosting a series of ‘webminars’ to assist users of its eSignature solution. The sessions start at 11 am and last up to 60 minutes, and will take place on January 22, February 5 and 19, and March 5.
The EMA has introduced capabilities to produce digitally signed electronic documents and to verify incoming digitally signed electronic documents from the areas of Scientific Advice, Orphan Medicines and Pediatric Medicines in portable document format (PDF). It provides specific PDF-certified electronic application forms that enable the pharmaceutical industry to digitally sign and submit using a PDF reader application. These capabilities are part of the strategy to increase electronic document-only exchanges with the pharmaceutical industry and regulatory bodies.
Industry will benefit by being able to exchange digitally signed documents, based upon specific acceptability criteria, according to EMA. The exchange of digitally signed electronic documents could bring cost savings to industry by removing the need to print documentation and incur courier charges. Electronic document exchanges also may increase efficiency and eliminate the requirement for archiving paper documents.
For further details about the webminars click here.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Ethical, Biosafety, and Scientific Review Considerations in Hematology and Oncology Clinical Trials
September 10th 2024The current oncology and hematology drug development pipeline features a wide array of large molecule therapeutics. As a result, clinical trial protocols have grown more complex, requiring sponsors, CROs, and research sites to tackle a variety of challenges that were less common with older, more traditional therapies.
