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

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?

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.

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.

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.

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.

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.

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.

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.