Newsletter | March 9, 2023

03.09.23 -- FDA Vs. EMA: Comparing Cell & Gene Therapy Requirements

Regulatory & Compliance
How Do Cell And Gene Therapy Requirements Differ Between The FDA And EMA?

Let's examine the similarities and differences between how the FDA and the European Medicines Agency approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

Assessing Human Abuse Potential To Limit The Misuse And Abuse of Prescription Drugs

Gain insight into how the FDA has undertaken efforts to limit drug abuse by instating guidelines to better understand the abuse potential of new drugs.

A Tool Kit For Sponsors And CROs Shifting Institutional Sites To A Central IRB

Discover how having all sites use a central IRB can build efficiencies and results in significant resource savings for everyone involved in the research study and improves human subject protections.

Outsourcing Models
New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Biopharma And Medical Devices
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (NIS2) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs, CROs and CDMOs, and manufacturers of APIs, biopharmaceuticals, and medical devices.
How CROs Can Optimize Revenue For Clinical Trials

Tracking billing and expenditures with notepads and Excel spreadsheets isn’t enough to meet client needs or auditing regulations. Explore a new software solution CROs are using to be more proficient.

Tailoring Bioanalytical Testing In A New Era Of Drug Development

Learn why pharmaceutical companies have to perform a comprehensive battery of tests to ensure product quality, safety, efficacy, purity, and stability through qualitative and quantitative characterization.

Overcoming Inventory Challenges For A Complex, Global Study

A CRO customer and a clinical sponsor both lacked an unblinded supply management role to oversee interactive response technologies (IRT) platform supply strategies and monitor inventory levels.

Ancillary Supplies: Clinical Trial ‘Must-Haves’ That Require Early Planning

Janet Williams, senior director, global supply chain management, and Julie Hoffman, senior director of commercial strategy and execution, discuss why ancillaries are as essential as IMPs, and why sponsors should devote as much attention to early planning for ancillary supplies as they do for study drugs.

Choose Your Own Adventure

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

Learn more about our personalized newsletters here.