Page 31 - New Employee Glossary

Glossary 31

Global Engineering & Facilities (GEF)

Function that globally provides and maintains facilities including services to support
Biogen's growth, profitability, workplace environment, and culture in a safe, secure, and
environmentally sound manner.

Global Expanded Access Program (GEAP)

Program that works to provide patients with early access to new therapies outside a clinical
trial for registration purposes or the commercial setting.

Global Medical Affairs (GMA)

Generates data by conducting Phase IV trials at a regional level, coordinating sponsored
research agreements (SRAs), and supporting investigator-initiated trials (IITs) for our
marketed products; analyzes trial data via biostatistics work and discussions with
investigators. Disseminates the data via publications and congresses (poster sessions).
Gathers insights from our prescribers and key opinion leaders primarily through our field
force, known as the Medical Science Liaisons (or MSLs).

Good Clinical Practices (GCP)

Standards on how clinical trials should be conducted; define roles and responsibilities of
clinical trial sponsors, clinical research investigators, and monitors

Good Laboratory Practices (GLP)

Framework within which laboratory studies are planned, performed, monitored, recorded,
reported and archived

Good Manufacturing Practices (GMP)

Standards for the control and management of manufacturing and quality control testing of
foods, pharmaceutical products, and medical devices

Gross Direct Operating Expense

Operating expenses before reflecting the impact of Accounting Adjustments for Capitalized
Inventory and Labor as well as Collaboration cost sharing.

Gross Margin