Advised pharmaceutical company on all aspects of compliance with the European Union General Data Protection Regulation (GDPR), including gap analysis, policy and procedure development, and vendor and other third party contract revisions.
What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory...
Presented to senior executives and other management of a start-up pharmaceutical company on complying with U.S. Department of Food and Drug Administration (FDA) advertising and promotion requirements pre- and post-launch.
Acted as the go-to advisor for a pharmaceutical company for advice on CAN-SPAM and E-Sign Act.
Served as on-site, long-term legal counsel for various pharmaceutical and device companies during times of staffing shortage at the companies.
Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.
Advised various pharmaceutical companies on the implementation of international clinical trials and related U.S. and ex-U.S. legal issues, including under FDA regulations, Health Insurance Portability and Accountability Act of 1996 (HIPAA), the GDPR, and...