How can Real World Evidence support Early Access to Medicine Schemes.

How can Real World Evidence support Early Access to Medicine Schemes. My presentation at the Conference of the International Society of Pharmacovigilance (ISOP 2025) in Cairo. Early access to medicines schemes (EAMS) allow patients with unmet medical needs to get innovative medicines quickly. EAMS shrink the drug development process which usually takes 12-15 years and a costs about $2.5 billion to be much shorter time and less expensive. Demonstrating the unmet need, the efficacy and safety of the products for EAMS is complex. The evidence is based on pharmacological and clinical evidence. However, in addition, real world data and evidence have key roles. Drug utilisation studies can identify the unmet medical need and identify patients who can be enrolled in clinical trials. Real world observational studies can shorten the development time by many years. They provide evidence for safety and effectiveness in real world usage which is complementary to clinical trials. Intensive monitoring by RWS after conditional approvals supports implementing any necessary modifications to the emerging benefit/risk balance and ultimately the conversion of the conditional authorisation to full approval. I will be glad to discuss this issue further, please contact me. Best wishes Professor Saad Shakir Consultant Pharmacovigilance Physician and Pharmacoepidemiologist