Voisin Consulting Life Sciences glossary icon
Glossary

Data lock point (DLP)

Loading..
Click a letter to view all its definitions

For a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.  

For a periodic benefit-risk evaluation report (PBRER), the date designated as the cut-off date for data to be included in a PBRER, based on the international birth date.  

For a development safety update report (DSUR), the date designated as the cut-off date for data to be included in a DSUR, based on the development international birth date.  

Other glossary definitions

A

Applicant for Clinical Trial Applications (CTA)

An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees. Applicant…

View definition
M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

View definition