kreiley

In today’s highly regulated global environment, pharmaceutical, biotech and medical device companies are under increasing pressure to demonstrate compliance across their extended third-party networks. From anti-bribery enforcement to FDA debarment risk to global supply chain integrity, life sciences organizations need more than just spreadsheets and checklists to manage their third-party risk. 

A modern […]

After its passage in June 2022, Italy’s Sunshine Act (Law 62/2022) is finally moving toward implementation—marking a significant development in life sciences transparency. The law introduces mandatory reporting obligations for financial relationships between life sciences companies and healthcare professionals (HCPs) or healthcare organizations (HCOs), including transfers of value (ToVs), financial interests, and service agreements.

Key Milestones […]

This is Part 2 in our blog series exploring a recent government enforcement action. Haven’t read Part 1 which covers speaker program compliance risks? Be sure to check it out here.

Recently, the Department of Justice (DOJ) reached a settlement with a global pharmaceutical company, resolving allegations that one of its subsidiaries paid kickbacks to […]

Since the Office of the Inspector General (OIG) issued its Special Fraud Alert in November 2020, speaker programs have remained under intense regulatory scrutiny. Recently, the Department of Justice (DOJ) reached a settlement with a global pharmaceutical company, resolving allegations that one of its subsidiaries paid kickbacks to healthcare providers (HCPs) to drive prescriptions of […]

In September 2024, the Department of Justice (DOJ) released an updated version of its Evaluation of Corporate Compliance Programs (ECCP) Guidance. The ECCP serves as a framework for DOJ prosecutors to evaluate a company’s compliance program when considering the appropriate enforcement actions. While updates were made across multiple topics, the most notable changes focus on […]

Pharmaceutical and medical device companies operate in a highly regulated and competitive landscape where efficient, compliant event management is essential. From medical congresses and training workshops to key opinion leader (KOL) meetings, these events shape industry relationships and drive innovation. As companies evaluate event management systems, they look for solutions that streamline processes, deliver educational […]

In September 2024, the Department of Justice (DOJ) released an updated version of its Evaluation of Corporate Compliance Programs (ECCP) Guidance. The ECCP serves as a framework for DOJ prosecutors to evaluate a company’s compliance program when considering the appropriate enforcement actions. While updates were made across multiple topics, the most notable changes focus on […]