A Medical Science Liaison Approach in connecting with Key Opinion Leaders Participant-Driven Educational Program: A novel approach to bring awareness to Fever Burden Reduction Abstract Successful, long-term thought leader relationships are forged through a pharmaceutical or medical device company’s ability to create mutually beneficial relationships with top … [Read more...]
Overview of Safe Harbors and Regulatory Compliance and the Impact on MSLs
Jennifer Williams PhD, JD, MBA, RN, MS This information is for educational purposes only and should not be construed as legal advice or a legal opinion from the author. This information is my own opinion and not that of past or present employers. Williams © 2016 During the past decade regulation has impacted the medical device and pharmaceutical industry; for better or … [Read more...]
Part Two: The First Amendment: Physician education using off-label indications to ensure that patients receive the most effective treatment.
Title Part Two: The First Amendment: Physician education using off-label indications to ensure that patients receive the most effective treatment. Authors Jennifer Williams PhD, JD, MBA, RN, MS Acknowledgements None Affiliations CR Bard Corresponding Author Jennifer Williams, PhD, JD, MBA, MS, RN Email: … [Read more...]
The First Amendment: Physician education using off-label indications to ensure that patients receive the most effective treatment.
Abstract: In today’s medical environment, a two-fold element of risk affects a medical device company. This risk is comprised of the risk of improper treatment through the agent’s lack of scientific disease-state knowledge, as well as the medical-device company’s fiduciary duty to ensure patient safety through facilitating proper education for the physician. The Food, Drug, and … [Read more...]