Regulations & Compliance STREAM

31. An Innovative Approach To Trial Results Summaries 12/3/2019

    See how sponsors are employing technology to replace outdated, paper-based patient communications about trial results. This innovative approach enables clinical trial sponsors to meet their ethical obligations to trial participants while simultaneously increasing patient engagement.

32. Quality Checks Vs. Quality Review 8/22/2023

    Watch this presentation where speakers share how teams can improve inspection readiness and reduce potential regulatory risks that could negatively impact operational activities.

33. Managing A Continually Evolving Disclosure Landscape 2/20/2024

    Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

34. Tackling The EU CTR Compliance Challenge 10/4/2018

    Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?

35. Beyond First Impressions: CTIS Lessons Learned In First 3 Months 5/19/2022

    Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to the portal.

36. How To Take Advantage Of Early Access Programs For The EU 6/12/2024

    Learn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.

37. How Standardized Terminology Can Accelerate Global Regulatory Performance 6/24/2022

    Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.

38. See How You Can Start Your Early Phase Program 6-9 Weeks Earlier In Canada 3/23/2023

    Vice President of Business Development Lisa Sanford explains whether you need an IND before starting your first-in-human trial in Canada.

39. The Journey From File To Trial: Automating Regulatory To TMF 2/9/2021

    In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions.  This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.

40. Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy 5/2/2025

    In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).