To Validate SaaS or Not to Validate SaaS? That is the Question…
Webinar Date/Time: Wednesday, September 13th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Join IQVIA Technologies’ expert, Lou Pasquale, to learn about the future reality of Computer Systems Validation (CSV) with SaaS.
Register Free: https://www.appliedclinicaltrialsonline.com/act_w/saas-validation
Event Overview:
Systems used to support clinical development have been, and still are, heavily impacted by FDA CFR 21 Part 11, ICH GCP E6 (R2) and the EMA. But are these regulations and their interpretations evolving with the changing landscape of SaaS solutions? And, as more clinical development systems are deployed via SaaS, how do the hundreds of thousands of global users, all accessing the same version of the same software, change the validation journey? Multiple software version releases each year, when held to the historical standards for Computer Systems Validation (CSV), may put the industry on a trajectory for staggering increases in the costs associated with validating a software solution.
Join IQVIA Technologies as we explore how the industry can adapt to this changing reality.
Three key take-aways
In this session, you’ll learn:
- The history of Computer Systems Validation (CSV): How did we get here?
- Current approaches to SaaS validation and managing the related costs and efforts: What’s working and what’s not?
- A future prediction: How can we take action now to effectively manage validation in the future?
Speaker:
Lou Pasquale
Director, eTMF Technology Solutions
IQVIA Technologies
Lou Pasquale leads the Client Services organization supporting IQVIA’s eTMF SaaS application and related technologies. Lou’s team performs new client implementations, provides migration and integration services, and delivers a variety of Professional and Managed Services for IQVIA’s eTMF customers. Lou has 30+ years of experience delivering software solutions and professional services to clients in Life Sciences and is a frequent speaker at industry conferences clinical quality, compliance, and related technologies.
Register Free: https://www.appliedclinicaltrialsonline.com/act_w/saas-validation
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 to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
What Can ClinOps Learn from Pre-Clinical?
August 10th 2021Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.
