Regulations & Compliance STREAM

1. Risk-Based Quality Review: Inside Out 8/29/2024

   Walk through how to manage and resolve the often conflicting internal and external directives to find the right path for you.

2. The Big Picture: Impact Of EU Disclosure On Small & Mid-Size Sponsors 5/6/2019

   With the new EU clinical trial registry portal expected to launch next year, it’s imperative that sponsors – particularly small and mid-size organizations – understand the complexities of EU disclosure. Thomas Wicks, an expert in clinical trial disclosure, and Karen Rutkowski, an expert in medical writing, share actionable insights on compliance.

3. Navigating Early Phase CNS-Active Drug Development 2/14/2023

   Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating the risk/benefit profile.

4. 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?

5. Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence 3/15/2024

   Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.

6. Plain Language Summaries Becoming A Mandate Worldwide 6/13/2024

   A growing number of countries are requiring clinical trial protocol and results disclosures to be written in plain language, influencing how these documents are authored.

7. Moving In Unison: Proprietary Scheduling Platform 6/18/2024

   Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.

8. TMF SUMMER SHORTS: House Of The Inspector 8/29/2024

   Discover key steps you can take to not just survive an inspection, but take the TMF Throne.

9. US And EU Regulatory Expectations For Combination Products 6/11/2024

   Explore the regulatory nuances in the US and EU for combination products in this on-demand webinar. Key topics include differing regulatory requirements, the influence of new guidelines, and more.

10. PLS Perspectives: Sponsor, Author & Regulatory Viewpoints 2/24/2020

    In this informative webinar, Jazz Pharmaceuticals will provide tips on launching a PLS program. A medical writer from ClaritiDox will give an overview of PLS best practices. And TrialScope’s chief strategy officer will share – and analyze – results from TrialScope’s recent PLS survey.