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The Renaissance Nashville Hotel   |   Nashville, Tennessee   |   November 18-21, 2024

Navigating the 510(k) Process for Menstrual Health Products

Wednesday, November 6th, 11:00 am EST

Chris Staab, QA/RA Consultant, Regulatory and Technical Associates

This presentation aims to demystify the 510(k) regulatory process for menstrual health products. It will provide comprehensive insights into special, traditional, and exempt categories, and the impact of material selection on product classification. Attendees will gain a deep understanding of Class I vs Class II devices, the integration of diagnostics in menstrual health, and the upcoming transition to ISO 13485 standards. We will also explore potential changes to the 510(k) process, ensuring manufacturers are well-prepared for future regulatory landscapes. The session will conclude with a Q&A segment, fostering an interactive environment for addressing specific regulatory concerns.

Industry Expert: Chris Staab

Chris Staab, a seasoned expert with over 20 years of experience in the medical device industry, will lead this presentation. Chris has a distinguished background in leading Quality and Regulatory teams, offering a wealth of knowledge and practical insights to help manufacturers effectively navigate the complex regulatory landscape.

Chris Staab

Harnessing AI to Enhance Transparency and Trust in Brand Sustainability

Wednesday, November 13th, 11:00 am EST

Ashish Chatterjee, Principal, INNOVATEGRN, and Pete Blackshaw, CEO and Founder, BrandRank.ai

As AI tools like ChatGPT, Google Gemini, and others become integral to daily search habits, consumers are increasingly turning to these platforms for reliable information about a brand's environmental efforts. Generative AI engines, diverse in their training and outputs, significantly impact consumer perceptions by providing instant answers to sustainability queries. A brand/company risks losing potential customers if its online content varies across different AI platforms, presenting conflicting information that may not fully reflect the brand's actual initiatives.

Using the coffee industry as an example, this presentation emphasizes why it is important for brands/companies to present their sustainability efforts clearly and consistently on all digital platforms. This ensures that AI systems can easily access and display this information, thus maintaining a brand's credibility and increasing consumer trust by aligning public claims with independently verifiable data through AI.

Additionally, brands can use AI-generated insights to compare their sustainability practices with those of competitors, identifying strengths and areas for improvement. The enhanced visibility provided by AI helps brands/companies better understand their position in the market and plan their long-term sustainability strategies.

In conclusion, generative AI not only boosts a brand's visibility but also ensures that its efforts in sustainability are communicated clearly and effectively. This is crucial for consumers making informed decisions, highlighting the vital role of AI in improving transparency and trust in brand sustainability.

Industry Expert: Ashish Chatterjee

Ashish is an accomplished global innovation executive and proven champion of open, connected, and collaborative innovation through 25+ years at Procter & Gamble. Ashish has a track record driving innovation breakthroughs and is an early AI adopter who has harnessed its power to uncover rich insights and dramatically accelerate speed to market.

He has extensive experience overseeing product innovation, sustainability, and supply chain programs worldwide. Ashish has delivered hundreds of millions of dollars in new sales revenue and cost savings, creating hyper-performant teams, using Gallup-strengths principles as a certified coach.

A passionate applied learner, Ashish empowers leaders and teams to achieve stretching innovation goals profitably, while reducing carbon footprint by use of cradle-to-grave life cycle analysis.

Ashish's work at Cintrifuse reinforces the benefit that small, focused teams have in learning and making faster decisions in a resource-constrained environment. Thus, Ashish seeks to blend this approach with his extensive innovative experience to support you on your journey to profitable sustainability.

Ashish Chatterjee

Industry Expert: Pete Blackshaw

A lifelong student of consumer feedback, brand promise, and technology, Pete is uniquely positioned to help companies navigate this change now underway. Most recently, Pete served as CEO of Cintrifuse, a Cincinnati-based startup catalyst and venture fund supported by major corporations such as P&G, Kroger, Scripps, and Western & Southern. In this capacity, Pete and his team served hundreds of startups.

Pete leads with two core beliefs: "Trust your inner consumer" and "Understand how startups work — how they think, design, exploit data, and iterate — and then apply that understanding to everything you do." These beliefs have been cornerstones of his career.

Before Cintrifuse, Pete served for eight years as Global Head of Digital for Nestlé, S.A. in Switzerland, partnering with hundreds of brands including Nescafé, KitKat, Purina, Nespresso, San Pellegrino. He created the industry-recognized Digital Acceleration Team (DAT), Silicon Valley Innovation Outpost (SVIO), and Open Innovation Platform.

Earlier, Pete held the title of CMO at NM Incite, a collaborative venture between Nielsen and McKinsey. His career trajectory began at Procter & Gamble, where he co-founded the first "Interactive Marketing" team and shortly thereafter, was recognized as "Interactive Marketer of the Year" by Ad Age. Following his tenure at P&G, Pete launched PlanetFeedback.com, a pioneering consumer feedback portal, which eventually became a part of Nielsen after several mergers.

Pete is the author of Satisfied Customers Tell Three Friends, Angry Customers Tell 3000, published by Random House, and is a frequent contributor to Ad Age. His contributions to the field have been acknowledged with numerous awards, including induction into the Word-of-Mouth Marketing Hall of Fame, MediaPost's "Online All Star," and the Advertising Research Foundation's "Great Minds" Award. He has also served as a juror for the Cannes Innovation Lions twice.

Driven by his commitment to fostering trust, Pete has served as National Chairman of the National Council of Better Business Bureaus and as a member of the National Advertising Review Board. At Nestlé, he championed the creation of the industry's inaugural "Consumer Engagement Principles," aligning top brands and retailers around shared values.

Pete holds an MBA from Harvard Business School and a Bachelor's degree from the University of California, Santa Cruz. He resides in Cincinnati, Ohio with his family.

Pete Blackshaw

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