The Top 5 Questions to Ask When Developing a REMS
A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance.
The Essential Role of Real World Evidence Combating COVID-19
Are you prepared for potential accelerated approval requirements?
ISPE’s Position on Real World Evidence (RWE)
Read more about the February 2020 position on RWE from ISPE.
Lack of Label Alignment & Patient Safety Implications
Read the full article from UBC’s pharmacovigilance team in Drugs Real World Outcomes.
Risk Management Plan Development & Implementation
Listen to the full podcast from UBC with PharmaVOICE here.
Are You Ready For Sentinel? | New RWE Safety Initiative
With continued investment in the RWE space, find out how to meet the needs of regulators, payers, and prescribers.
Immunogenicity: Meeting the Safety Reporting Requirements
Discover why it is imperative to assess the potential of therapeutic proteins throughout the product lifecycle.
DIA 2019: Watch the Wrap-up of UBC’s Participation
See more of the developments UBC’s evidence development and safety & risk management teams discussed.
UBC Presents Observational & Investigational Studies
Watch Chief Scientific Officer Dr. Annette Stemhagen discuss in this video.
Clinical Trial Trends – OCT West Coast Conference Wrap-Up
Read the latest in the world of clinical trials out of this industry event.
