Newsletter | October 10, 2024

10.10.24 -- Compassionate Use Program (CUP) Benefits & Strategies In Rare Disease

SPONSOR

With ICH M11 expected to be adopted by the end of the year, the next Clinical Leader Live digital event will host a panel discussion on the advantages of improving and simplifying the dataflow of clinical trials but also the challenges associated with creating a connected digital dataflow, including digital health channels, that spans from protocol to data collection to CSR. Register today and join us on 10/31 at 1 pm ET (10 am PT).

REGULATORY & COMPLIANCE

Compassionate Use Program (CUP) Benefits & Strategies In Rare Disease

Guest Column | By Davelyn Eaves Hood, Rezolute and Ana Tediosi, WEP Clinical

In part two of this series, Rezolute discusses the benefits of continuing patient care with a compassionate use program (CUP) and shares best practices for implementing one.

Navigating New EU Trials Regulation Requirements For Clinical Supplies

Article | Catalent

Better understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategy that adhere to the new requirements.

Achieving Success With Regulatory Intelligence In PV

Article | ProPharma

Review what pharmacovigilance (PV) entails and the regulatory intelligence services that could help your company monitor external regulatory changes and ensure compliance through customizable services.

OUTSOURCING MODELS

The Value Of A High-Performing Regulatory Function Within A CRO

Guest Column | By Pete Embley, BSc. (Hons), FTOPRA, INSTEAD, Sunshine Reg Services Ltd.

Consultant Pete Embley discusses the value a regulatory expert brings to both CROs and sponsors alike.

Weighing FSP Model Suitability For Clinical Trials

Article | Veristat, Inc.

Consider several key points outlined in this article when deciding if a functional service approach could better serve a clinical team and its drug development study.

How To Establish Effective, Scalable Drug Safety Ops Across Vendors

Article | By Rosa Lee Smith and Raul P. Lima, inSeption Group and Elizabeth Delmaestro, Independent Consultant 

Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

Autoinjectors: A Revolutionary Leap In Drug Delivery

Article | By Bill Welch, PCI Pharma Services

Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

Biorasi India Is Your Guide To Successful APAC Trials

Video | Biorasi

Learn how Biorasi’s India office has developed into a team of top performers with expertise across all vital components of clinical trial execution.

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  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
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