Page 65 - New Employee Glossary

Glossary 65

Summary of Clinical Efficacy (SCE)

A summary of how well a treatment works in a clinical trial.

Summary of Clinical Safety (SCS)

A summary of data relevant to safety in the intended patient population, integrating the
results of individual clinical study reports as well as other relevant reports.

Summary of Product Characteristics (SmPC or SPC)

Document required in the EU that provides a summary of the product in terms of its
properties: chemical, pharmacological, and pharmaceutical.

Supplemental Biologics License Application (sBLA)

An application to allow a company to make changes in a product that already has an
approved Biologics License Application (BLA).

Supplementals (SUPP)

Supplemental employees are future planned positions expected to be filled by a temporary
or contract hire

Supplier Lifecycle Management (SLM)

Corporate tool used to collect key information about all suppliers in use at Biogen.

Suppliers

Vendors

Suspected Unexpected Serious Adverse Reactions (SUSAR)

A type of SAE that is related to the study drug & unexpected.

Synapse

Internal website which provides news and information and shares documentation across the
Biogen community

T

Talent Acquisition (TA)