Time & Location
About The Event
Want to start a medical device company but don't know about the laws and regulations? Working on a novel technology that is going to change healthcare? Are you MedTech professional curious about the FDA?... The MIx Regulatory Roundtable is the perfect event to expand your personal understanding and growth in this area!
This jam-packed evening will feature round-table discussion and presentations with healthcare and medical device industry leaders. Experts and professionals in regulatory and FDA affairs will be offering practical and tangible advice to help MedTech professional avoid pitfalls and succeed in the FDA regulated industry. The night's discussions will be facilitated by industry leaders in healthcare regulatory law.
SPECIAL GUEST FACILITATORS:
Lee Rosebush has a background as a defense, regulatory, and registered patent attorney who has also worked as a registered pharmacist. Lee provides legal counsel related to the naming of drugs, clinical trials, marketing, promotions, or advertising. Lee has a background in the pharmaceutical industry as well as experience in biologics, medical devices, and healthcare companies. Lee holds post-graduate degrees in finance and business and frequently works on corporate deals involving healthcare entities. Lee is active with the Drug Quality and Security Act (DQSA), as well as the Federal Food and Drug Administration's (FDA) regulation of pharmacy compounding. Lee speaks and writes on both issues, and is passionate about orchestrating and advocating for pharmacists and pharmacies.
Lindsay focuses her law practice on regulatory and transactional matters primarily in the healthcare and life sciences industries. She has experience advising clients on Food and Drug Administration FDA) regulatory matters including drug, device, dietary supplement and cosmetic issues, as well as matters related to 503B outsourcing facilities and the Drug Quality and Security Act (DQSA). She also helps pharmacy clients navigate state licensing and pharmacy practice act issues. Additionally, Lindsay has experience counseling clients on data privacy and security matters, fraud and abuse, and Medicare Part D.
Facilitators will discuss how to meet the regulatory challenges in getting approval for a novel model technology, how to navigate the FDA’s most-stringent pre-market approval path, and establishing a relationship with the agency. They will advise on how to build a regulatory strategy for CE mark in Europe. Professionals will collaborate and discuss all things related to FDA, clinical trials, marketing, promotions, or advertising and pitfalls that can delay or derail the development process.
September 11th, 5:30-7:45 PM
5:30-6 PM- Meet and Mingle
6-6:35 PM First Presentation and Round-table #1
6:35-6:50 PM Break
6:50-7:25 Second Presentation and Round-table #2
7:25-7:45- Wrap Up and Meet The Community
- Early Bird$15$150$0