Category Archives: compliance

Promotional Review Committees: Shire Sets the Standard on Achieving High Performing Teams

by Arthur Lazarus What does it take for internal Promotional Review Committees to function at their best and avoid costly mistakes to the company? A leading industry practitioner offers 15 tips for high performing teams. Arthur Lazarus, MD, MBA, Shire Pharmaceuticals 1. Find a common voice. Given the diverse training and background of individuals who […]
Also posted in E-Media, Legal, Marketing, Strategy | Tagged , , , , , , , | 2 Comments

The Curious Case Of AstraZeneca v. ACE

by Mike Kelly and Andrew Dupre Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned. From 2003 to 2012, AstraZeneca Plc was locked in one of the largest mass tort litigations in the United States, defending its blockbuster second generation atypical antipsychotic product Seroquel from allegations of failure-to-warn of […]
Also posted in Europe, Guest Blog, leadership, Legal, Marketing, Regulatory, Safety, Sales, Strategy | Tagged , , , , , , , , | Leave a comment

Compliance and Reporting: The Case for a Single System

by James Pierce Pharmaceutical companies are awash in a sea of compliance regulations that affect their business operations both inside and outside the US. This August, one more compliance wave will crest when the Physician Payments Sunshine Act (PPSA) begins requiring pharmaceutical companies to track and report virtually all payments to health care providers (HCPs). […]
Also posted in Corporate Responsibility, E-Media, Europe, FDA, Global, Guest Blog, Marketing, Regulatory, social media, Strategy, Technology | Tagged , , , , , , , | Leave a comment

Breaching the Great Wall: Major Pharma Changes Proposed in China

With a revision of China’s basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation. Dr. Wang Chenguang, Dean of Tsinghua Law School Behind the vaulting growth statistics that make China the centerfold in Big Pharma’s global playbook is a […]
Also posted in Emerging Markets, Global, IP, R&D, Regulatory | Tagged , , , , , , , , , , | 3 Comments

Lanham Act: Peer-Review on Trial

Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage? The dividing line between fact and fiction becomes increasingly blurry in the age of prolific […]
Also posted in Advertising, Legal, Marketing, Regulatory, Strategy | Tagged , , , , , , , , , | Leave a comment
  • Categories

  • Meta