Unlock faster global development by integrating EU and UK regulatory strategy early. Proactive planning and effective implementation can accelerate approvals, avoid delays, and maximise ROI for US biotech and pharma companies. We will explore paediatric requirements, navigating clinical trial applications and authoring of effective clinical and regulatory documents.
Topics
- Clinical Trial Applications in the EU including CTIS Platform
- EU Paediatric Investigation Plans (PIPs)
- Medical Writing Essentials for EU Submissions
