Advanced Therapy Medicinal Products (ATMPs) in Clinical Trial Safety Services – Webinar.
Arriello presents Kieran O’Donnell and Esther Poole in Xtalks webinar on the topic of ATMPs in Clinical Trial Safety Services.
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. Taking a medicinal product through clinical development is already a long, complicated, and expensive exercise, but developing an ATMP is likely to be more complicated, more expensive, and presents particular challenges and opportunities for pharmacovigilance and drug safety.
These challenges often take the form of:
- Idiosyncratic protocol design;
- Proactive detection of risks;
- Risk mitigation and treatment frameworks;
- Long-term follow-up obligations.
This webinar explores those challenges and the means to address those opportunities to add real value in the management of ATMP clinical trials.