The impact of real-world data in gaining access to the European orphan drugs market.
Europe presents a significant opportunity for international biotech’s developing and commercialising rare and orphan medicines.
With the EMA’s increasing focus on Real-World Data in its regulatory processes, there are several ways in which applying it can help speed up access to the European market.
This essential guide covers:
- What is Real-World Data and how it is used in the pharmaceutical industry
- How RWD can help to speed up access to European markets
- The importance of RWD in regulatory and HTA submissions
- RWD as a strategic tool for pricing and reimbursement negotiations
- The advantages of RWD over controlled clinical trial data
- The EMA’s recognition of RWD
Download this exclusive guide to discover how Real-World Data can improve your chance of success in this complex market.