HAVE I GOT VIEWS FOR YOU | YOUR QUESTIONS ANSWERED
Highly Interactive Panel Discussion on Quality, Manufacturing, Regulatory, Patient Engagement and Clinical Considerations to Accelerate New Medicines to the Clinic.
You ask the drug development questions, and the panel will share their views. Join us for an engaging and experience-sharing session to discuss the questions that are on YOUR agenda – from the Trump administration to clinical trial diversity, artificial intelligence to EU pharma reform.
Key Topics Expected to Include
Innovator hot topics across drug development domains: Quality, CMC, Regulatory, Clinical Development & Patient engagement
Development pathways for new medicines with a spotlight on ATMPs and challenges encountered by innovators.
Early development challenges for innovators
How organisations should interact with regulators to gain successful outcomes for therapies in rare diseases in US, EU and UK
Patient engagement & recruitment for trials in rare diseases
Learning Objectives
Greater understanding of the hot topics facing innovators in today’s environment
Understand regulatory challenges developing therapies in rare diseases
Appreciate key challenges for cutting-edge therapies like ATMPs which include manufacturing and controls, cost, accessibility & other ethical considerations
Understand common regulatory challenges facing SME companies & how they may differ to established biotech and pharma
Know where to find suitable supportive resources
