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 that could help to speed the regulatory review 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 be asked to discuss the most important strategic aspects before embarking on a particular pathway.
Who Should Attend
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.
At the conclusion of this tutorial, attendees will be able to:
- 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