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.
Served as on-site, long-term legal counsel for various pharmaceutical and device companies during times of staffing shortage at the companies.
Informed Consent Form Templates
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.
European Union GDPR—Pharmaceutical Company
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.
Acted as the go-to advisor for a pharmaceutical company for advice on CAN-SPAM and E-Sign Act.
International Clinical Trials
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 foreign research and privacy laws.