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.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.