KEYNOTE | PMTA Module 5 & 6 Regulatory Expectations & Business Objectives

7th Annual Next Generation Nicotine Delivery USA Conference

KEYNOTE | PMTA Module 5 & 6 Regulatory Expectations & Business Objectives

Dr. Jessica Zdinak, our CEO and Chief Research Officer, gave a keynote presentation focused on bridging the gap between product development and market success in the tobacco and nicotine industry, particularly in light of regulatory expectations and consumer behavior. Zdinak emphasized the importance of understanding consumer needs and market dynamics to inform product innovation and regulatory strategies.

Overall, the presentation underscored the critical role of comprehensive research and consumer understanding in navigating the complexities of the tobacco and nicotine market, ultimately aiming to enhance public health outcomes while achieving business objectives.

WATCH BELOW > PRESENTATION REPLAY CLICK HERE for PRESENTATION SLIDES

KEY TAKEAWAYS:

• CONSUMER-CENTRIC APPROACH: Understanding consumer wants, needs, and behaviors is crucial for successful product development. This involves conducting thorough needs assessments and feasibility studies before launching products.

• REGULATORY LANDSCAPE: The evolving regulatory environment, including state-level flavor bans and FDA guidelines, requires companies to stay informed and adaptable. Companies must ensure compliance to avoid legal ramifications.

• DATA-DRIVEN INSIGHTS: The importance of robust, reliable data in informing product development and regulatory submissions was highlighted. This includes utilizing both behavioral and clinical data to support claims about product safety and efficacy.

• RISK-BENEFIT ANALYSIS: A nuanced understanding of the risk-benefit ratio is essential. The presentation discussed the need to consider both individual and population-level impacts of tobacco products.

• BRIDGING MODULES: The speaker discussed the integration of findings from different regulatory modules (Module 5 and Module 6) to streamline the application process and reduce costs for clients.

• REAL-WORLD IMPLICATIONS: The presentation included hypothetical scenarios illustrating the consequences of inadequate market research, underscoring the financial and strategic risks of launching products without proper consumer insights.

• TESTIMONIALS: Personal anecdotes from study participants were shared to highlight the real-life implications of tobacco product use and the importance of addressing consumer perceptions and misperceptions.

• REGULATORY COLLABORATION: Building relationships with regulatory agencies like the FDA is vital for gaining insights and improving the likelihood of successful product approvals.