Tutorial 09: EARLY ACCESS SCHEMES: CONSIDERATIONS FOR DEVELOPING REGULATORY STRATEGIESDay & Time:
March 25, 9:00AM - 12:30PM (Central European Standard Time)Room Number:
Patients are waiting to obtain access to novel medicines. Regulatory processes exist that may aid faster access for patients. However, not every approach is applicable for all circumstances. Additionally, other approaches are being developed such as Adaptive Licensing that could help to speed the development process while maintaining the robust assessment of benefits and risk. Strategic considerations need to be taken into account when determining which approach to follow. The different processes will be outlined and, using different situations, participants will discuss the most important strategic aspects before embarking on a particular pathway and the future impact of proposed new pathways.Learning Objective(s):
• Distinguish and compare the options available for faster regulatory approval in the major global regions
• Assess the merits of each option to evaluate the best strategic course of action
Medical affairs, regulatory and all other industry experts who want to understand how different regulatory approaches can help contribute to getting innovative medicines to patients faster.