Compliance

 

TerSera Therapeutics LLC is committed to a corporate culture that promotes full compliance with the highest legal and ethical standards in the healthcare industry. This approach is essential to our mission of making a difference for patients. We expect all employees to adhere to this commitment by obeying all relevant laws and industry standards. This includes full compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals.

Additionally, in 2003, the Office of Inspector General (OIG), Department of Health and Human Services, developed the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. In acknowledgement of the OIG’s fundamental elements of an effective compliance program, we have implemented a Compliance Program that:

  • fosters a culture of compliance at all levels in every department, emphasizing open-door policies to facilitate communication;
  • establishes written policies and procedures, which reflects the highest standards in our industry;
  • designates a Compliance Officer and establishes a Compliance Committee;
  • requires effective training and education for all employees regarding applicable laws, company policies, and industry standards;
  • develops effective lines of communication to ensure internal reporting of misconduct or questionable activities to support timely investigation and resolution;
  • calls for continuous monitoring and auditing of compliance policies and procedures;
  • details specific disciplinary policies that may be warranted for noncompliance; and
  • ensures appropriate corrective action upon receipt of reasonable indications of noncompliance with applicable laws, policies, and standards.