Gain a deeper understanding of regulatory readiness and its critical role in life sciences investments at this focused seminar. Focused predominantly on the particular requirements related to medical and wellness devices, the session will clarify US FDA regulatory pathways and their intersection with intellectual property and business law. The discussion will concentrate on medical devices, with clear distinctions from pharmaceutical and combination products, emphasizing their impact on market access, risk assessment, and investment outcomes.
A panel of experts in regulatory strategy, intellectual property, and corporate law will illustrate how regulatory preparedness directly influences valuation, due diligence, and return on investment. Attendees will leave with actionable insights into the alignment of legal, regulatory, and business considerations within the commercialization process.
Who Should Attend:
- Investors and Due Diligence Teams: To assess regulatory risk and investment opportunities
- Entrepreneurs and Innovators: To prepare for regulatory milestones that drive commercialization
- University Affiliates and Aspiring Innovators: To translate discoveries into market-ready ventures
Key Topics Include:
- Differences between device classifications and their individual regulatory requirements
- Regulatory misconceptions that affect market timelines and valuations
- The relationship between regulatory strategy, intellectual property, and business law
- How regulatory readiness informs due diligence and reduces investment risk
This event, hosted by Keiretsu Forum, is open to members, portfolio companies, and partner universities. Participants will gain a comprehensive understanding of how regulatory preparedness shapes life sciences investment success.