Pharmaceutical And Medical Device Compliance Manual PDF Download

Now more than ever, doctors are being targeted by government prosecutors and whistleblowers challenging the legality of their relationships with drug and device companies. With reputations at stake and the risk of civil and criminal liability, it is incumbent upon doctors to protect themselves. Managing Relationships with Industry: A Physician’s Compliance Manual is an indispensable resource for doctors, professional societies, academic medical centers, community hospitals, and group practices struggling to understand the ever changing law and ethical standards on interactions with pharmaceutical and device companies. It is the first comprehensive summary of the law and ethics on physician relationships with industry written for the physician. Authored by a former state Attorney General, Harvard Medical School Professor, health care lawyer and professor of ethics, Managing Relationships approaches the topic from a balanced and reasoned perspective adding to the on-going national dialogue and debate on the proper limits to medicine’s relationship with industry. The first complete and up-to-date summary and analysis of the law and ethics on physician-industry relationships Focuses on major enforcement actions and whistleblower lawsuits and the lessons learned for physicians Provides options and guidance for maintaining compliant relationships and avoiding traps for the unwary Covers both drug and device company relationships Summarizes the types of industry relationships that are necessary and productive and those that are harmful and abusive Details the law and ethics for each type of relationship including gifts, off-label uses and marketing, CME, speaker’s bureaus, free samples, grants, consulting arrangements, etc. Includes sample contracts for permissible consulting and CME speaker engagements