As more companies implement regulatory information management systems and get a handle on their regulatory data, they are looking to enhance the regulatory intelligence capabilities and leverage their data to further optimize regulatory strategy and submissions planning to reduce the time it takes to get new therapies to patients. In this webinar, we will explore what companies are doing in the regulatory intelligence space and how they’re leveraging artificial intelligence and all the information they have from health authority interactions to optimize decision making. Additionally we will examine how regulatory intelligence teams are evolving and how they are measuring success.
Regulators have made it abundantly clear - through recent guidance and inspection findings - that demonstrating sponsor oversight of an outsourced study is a critical requirement for TMF health and inspection-readiness. Join this webinar to discover how global biopharmaceutical company Chiesi and its CRO partners collaborate to ensure ongoing oversight compliance, in the face of increasing documentation requirements and trial complexity.
Following last year’s well-received “Clinical Trials 101 and the TMF” series, Phlexglobal is pleased to announce a new learning series to help elevate your knowledge of clinical trials and the Trial Master File: “TMF Management in Clinical Trials.”
Join industry expert Rob Jones, Phexglobal’s Director of Professional Services, as he leads us through three critical topics:
We’ll be taking the same knowledge-sharing and interactive Q&A format as before, since we all learned pragmatic tips and tricks from you and your peers. In between our online events Rob and his team will author a series of in-depth webinars on the topics.
| WEBINAR: Increasing Value from Health Authority Interactions and Regulatory Intelligence - What's Next? | 
Cary Smithson
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| ASK AN EXPERT: Clinical Trials and TMF101 Learning Series Q&A | 
Rob Jones
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| WEBINAR: Clinical Trials and TMF 101 Learning Series |
Rob Jones |
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| ASK AN EXPERT: TMF Reference Model Q&A - Round 2 |
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WEBINAR: How Standardized Terminology Can Accelerate Global Regulatory Performance |
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ASK AN EXPERT: Examining the "Why" and "How" of Integrating Your eTMF and CTMS |
Jim Horstmann
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WEBINAR: The Next Phase of Intelligent Regulatory Business Process Automation is Here |
VP Solutions Consulting |
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ASK AN EXPERT: TMF Reference Model Q&A - Round 1 |
 Lisa MulcahyPrincipal Consultant, Mulcahy Consulting  Karen RoyChief Strategy Officer |
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WEBINAR: Benchmarking Survey Launch: Are EU CTR and CTIS Driving Tighter Clinical & Regulatory Integration? |
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WEBINAR: Do You Know Your TMF Health Score? |
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ASK AN EXPERT: How to Ensure TMF Inspection Readiness & Compliance for a Recently Acquired Product |
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Steve Gens
Eldin Rammell
Cary Smithson
John Stanek - Johnson & Johnson
Peter Terbeek - Astellas
Aaron Grant
Jim Nichols
Marc Webb
Sarah Tucker