Navigating the EU regulatory landscape in 2022 and beyond: Accelerating drug development, treatment innovation and market access
Webinar series on demand
The EU legislative framework is currently undergoing a period of substantial change to react to a seismic shift in scientific and technological advancements. During this three-part webinar series, we will cover key areas sponsors must be mindful of during drug development in preparation for filing successful regulators submissions.
The future of decentralized clinical trials in an evolving EU regulatory landscape
The COVID-19 pandemic has demonstrated the feasibility of adapting clinical trials from site-based endeavors to fully decentralized or hybrid models and has increased global acceptance of decentralized trials as a safe and effective option for accelerating clinical research. Enabled by digital, technological, and logistical innovations, decentralized clinical trials offer advantages that will endure beyond the pandemic.
In this webinar, you will learn from our experts, Aruna Talapatra and Scott Emery, as they review the regulatory and geographic factors that can influence the adoption of DCTs, and it will provide a roadmap for implementing decentralized clinical trials within the current legal environment in Europe. Specifically, the presentation will address the critical importance of the following:
- A robust and secure technology architecture for trial related data acquisition, storage, and communication
- A drug distribution and management strategy that meets all stability, storage, and dosing access and administration requirements
- A high-level understanding of the evolving EU regulatory landscape to ensure compliance with good clinical practice (GCP) requirements and all relevant legislation
Entering first-in-human clinical trials: A five point strategy for building a robust CMC dossier
Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing regulatory CMC guidance and careful preparation of quality dossiers are integral to success from the very early stages and throughout clinical development.
This webinar discusses the five strategies to build a robust CMC package, help streamline the path to FIH trials for biologics and establish the quality foundation needed to support all of the development phases toward commercialization including :
- Regulatory CMC in early development teams
- Keeping patient and clinical experience in mind
- Building a phase-appropriate dossier
- Considering and conveying the basis for the strategy
- Obtaining regulatory advice at every opportunity
Flexible regulatory pathways and key CMC considerations to commercialize cell and gene therapy products
The rapid expansion of the cell and gene therapy pipelines in recent years offers significant potential to cure diseases with great unmet medical need. However, the unique nature of these therapies poses challenges to regulating them within traditional frameworks and regulatory expertise is not uniform across regions.
This webinar will provide key advice for determining and navigating the regulatory pathway for any cell and gene therapy, including the following:
- Early, proactive engagement with the established regulatory authorities that specialize in the evaluation of cell and gene therapies
- The key components of programs to accelerate application review within major regulatory jurisdictions
- Critical considerations for site selection and CMC development of viral vectors for cell and gene therapies