ACRP is organizing an online teaching session about regulatory inspections, to be held on May 14, 2014.
The Association of Clinical Research Professionals (ACRP) is organizing an online teaching session about regulatory inspections, to be held on May 14, 2014.
The event will examine common findings from inspections by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). The plan is to use a “lessons learned” approach to help identify and prevent common inspection findings related to essential document collection and retention.
According to a statement from the organizers, “This Webinar delves into essential document collection and retention by first identifying what essential documents are and why they are necessary. The presenter will then cover essential document requirements and responsibilities in clinical research, followed by essential document retention requirements.”
Also, the program will cover any differences between ICH/GCP, FDA, and the EU Clinical Trials Directive in the requirements and retention of essential documents.
The event is designed for experienced research nurses, investigators, research assistants, research associates, project managers and all other staff who are directly involved in performing clinical research who are familiar with the terminology. The presenter will be Judith van Heel, who formerly worked for Bristol Myers-Squibb and Novartis and CROs Kendle International and JCR).
The event will take place from 12 noon to 1.30 pm US Eastern Time. The cost of registration is $99 for members and $149 for non-members.
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
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.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
July 7th 2025How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.