Registration is Now Open!

8:00-8:15 A.M. 

Welcome Remarks & Award Presentation 

Scott Furness, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA 

Glen Murphy, Senior Director Regulatory Affairs, Kenvue and 2025 RSQ Conference Planning Committee Chair

Award Presentation: 

Glen Murphy, Senior Director Regulatory Affairs, Kenvue and 2025 RSQ Conference Planning Committee Chair

8:15-9:15 A.M. 

GENERAL SESSION: FDA Leadership Panel Discussion

Hear from the heads of CDER, CDRH, and HFP regarding an overview

of their staffing, perspectives on self-care, and more specifically, Agency priorities 

and projects related to over-the-counter (OTC) drugs.

9:15-10:00 A.M. 

GENERAL SESSION: The Impact of AI on the Pharmaceutical Industry 

AI experts will discuss the impact of AI on the pharmaceutical industry, highlighting its ability to automate manual tasks and improve product quality. They will explore how AI can analyze data to predict issues, detect patterns in real-time, and enhance patient safety and drug innovation. Attendees will learn about current AI applications in FDA-regulated industries, their benefits for quality management, R&D, and the challenges of implementation. 

10:00-10:15 A.M. 

Networking Break 

10:15-11:00 A.M. 

GENERAL SESSION: Executive Orders/Tariffs/Counterfeit/Illicit Trade

This session will examine recent Executive Orders addressing tariffs and reducing regulatory burdens. The panel will identify potential effects on industry and global supply chains, including how these changes may impact illicit trade in the consumer health space and how companies can respond. 

BREAKOUT #1: Exploring ACNU/Switch and Benefit-Risk 

(REGULATORY) FDA’s new ACNU (Additional Condition for Nonprescription Use) NDA pathway permits use of technology to transform medication access, offering a consumer-focused, equitable approach that meets diverse needs.  In December 2024, FDA finalized the ACNU NDA regulatory pathway, introducing an additional route for patient medication access.  This pathway offers a tailored approach, while aligning with individual medical needs and circumstances.  An ACNU drug may include validated technology interfaces, instead of healthcare provider prescriptions, to determine if self-directed consumer access to the drug is appropriate without a prescription.  

The ACNU pathway creates an opportunity for sponsors to develop novel mechanisms for medication access that are activated when a consumer completes a necessary ACNU "condition" that ensures only appropriate patients can access the medication, in the nonprescription setting.  Grounded in digital technology, potential solutions enable more personalized and flexible access, expanding options for consumers while ensuring safety and efficacy.  By reducing barriers, the ACNU framework has the potential to improve the consumer experience, health equity and public health. 

 

As sponsors navigate this new regulatory roadmap, it will be critically important to identify endpoints and targets appropriate for individual R&D programs.  One stop along this switch journey is to determine the benefit/risk profile of the drug product.  Dr. Eric Brass will provide insights for how to evaluate and memorialize the benefits unique to OTC drugs during the approval process. 

BREAKOUT #2: FDA GRAS Rule: What Would Changes Mean for Self-Care Products 

(DIETARY SUPPLEMENTS): The FDA's Generally Recognized as Safe (GRAS) rule allows ingredients added to the food supply to be considered safe, provided they meet certain safety standards. Companies can either submit a GRAS notice to the FDA or self-affirm their ingredients as GRAS through expert review. An ingredient that GRAS and in the food supply can be also added to dietary supplements and OTC drugs.  For years changes to the GRAS rule have been discussed among industry experts, policymakers, and consumer advocates. Recently, Robert F. Kennedy Jr. proposed eliminating the self-affirmed GRAS pathway to increase transparency and ensure all new food ingredients undergo FDA review. This proposal has sparked debate, with some advocating reform as a necessary step for consumer safety, while others arguing the current rule balances consumer access and safety. Join us to explore the history of the GRAS rule, examine alternative proposals, and debate their impacts on transparency, safety, and industry innovation. 

Moderator:

Ann M Begley, Attorney, Wiley Rein 

Speakers: 

Ricardo Carvajal, Hyman, Phelps, & McNamara 

Corey Hilmas, M.D., Ph.D., Chief Regulatory Officer, KGK Science, Inc. 

 

BREAKOUT #3: FDA Inspections 

FDA warning letters (WLs) are official notifications from the FDA to manufacturers that have violated federal regulations. These letters are important because they highlight significant compliance issues, such as poor manufacturing practices, misbranding, or adulteration, and provide an opportunity for the recipient to address these concerns. WLs are issued when the FDA identifies serious violations during inspections or reviews, and they typically request a response within a specified timeframe. This process ensures that the necessary corrective actions are taken to protect public health and maintain regulatory standards.

The FDA recently faced a significant reduction in force and is navigating new leadership and priorities set forth by the new presidential administration and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.  Experts from Eliquent Life Sciences will provide an overview of recent trends in warning letters related to drugs (including OTC medicines) and biologics to highlight key areas of focus and note any impacts attributable in part to the recent RIFs and change in administration.

 

Moderator: 

Fred Meadows, Ph.D., Senior Director, Quality Technical and Regulatory Affairs, CHPA

Speaker: 

Kalah Auchincloss, Principal & Deputy General Counsel, Eliquent Life Sciences 

 

12:15-1:15 P.M.      

LUNCH 

1:15-2:00 P.M. 

GENERAL SESSION: Disinformation Risks to Consumer Healthcare Brands

Disinformation campaigns and social media manipulation often originate or gain traction within fringe communities, but these conversations are increasingly reaching the mainstream. 

Information is being weaponized to directly target companies, their brand, and their employees. Various actors create false narratives, use cultural touchpoints, and feed off public distrust of corporations and information sources. 

Speaker: 

Lisa Kaplan, Founder and CEO, Alethea 

 2:15-3:15 P.M.

BREAKOUT #4: Intersecting Other Trade Associations 

(REGULATORY) Join this insightful session with representatives from PCPC, and American Cleaning Institute. Discover how these trade associations navigate their interactions with the FDA and address various industry challenges. The discussion will particularly focus on ingredient-specific issues and the strategies employed by each association to manage them effectively.

Speaker: 

James Kim, SVP Science & Regulatory Affair,  American Cleaning Institute 

BREAKOUT #5: TBA 

 

BREAKOUT #6: Patient Preferences for Access to OTC Medications for Allergic Eye Symptoms: A Discrete Choice Experiment

The University of California – San Francisco, School of Pharmacy, conducted research to better understand how individuals choose treatments for eye allergies. The findings will provide insight into consumer’s acceptable risk and benefit trade-off when self-selecting OTC medicine, pharmacy advised OTC medicine, and physician prescribed medicine.

3:15-3:30 P.M.

Networking Break 

3:30-4:15 P.M

GENERAL SESSION: States Leading the Way: Navigating New Frontiers in Consumer Healthcare Regulation

As federal lawmaking stalls, states are increasingly stepping into the regulatory vacuum - proactively acting on issues like chemical restrictions, counterfeiting, and packaging requirements for consumer healthcare products. For this session, CHPA staff will sit with a former Attorney General and explore how states are acting as "laboratories of democracy", highlighting trending legislation, emerging policies, and the challenges of implementing fragmented, state level regulations for the industry. The experts will offer insights into benefits and drawbacks of the shift, how Attorneys General are becoming more politically involved with the Legislature and political leaders, and what it means for industry, advocates, and consumers.

4:30-6:00 P.M.

Reception 

7:00 A.M.-12:30 P.M.

Registration 

8:00-8:45 A.M. 

GENERAL SESSION: New Approach Methodologies to Replace Animal Testing

FDA recently released a Roadmap outlining a transition from requiring animal testing for safety assessment of drug products to using New Approach Methodologies (NAMs), which can provide more timely and predictive information relevant to human exposures. Learn more about how these cutting-edge techniques can help improve predictive accuracy while reducing animal use and how the acceleration and validation of NAMs could be a significant win for the consumer product industry. 

Speaker: 

Nicole Kleinstreuer, Ph.D., Acting Deputy Director for Program Coordination, Planning, and Strategic Initiatives, NIH  

9:00-10:00 A.M.

BREAKOUT #7: OMUFA OMORs GRASE and the implications for the Industry

(REGULATORY) This session will provide an update on the progress and implications for the industry regarding OMUFA. With the upcoming reauthorization in September 2025, it promises to be a vital discussion point. This session will feature industry speakers, who will share insights on the successes of OMUFA I and outline expectations for OMUFA II.

BREAKOUT #8: Nutrition and Brain Health: Preventing Cognitive Decline

(SCIENCE) In this comprehensive session, we will explore the connections between our diet, supplements and  brain health. Emphasizing the role of food, nutrients and specific bioactive compounds  on brain function and the risk of cognitive decline and dementia. Key topics include the impact of various nutrients and bioactive compounds on cognitive functions, key nutritional biomarkers, dietary patterns associated with improved brain health, metabolic processes influencing brain activity, and preventative strategies through nutrition. 

Participants will gain an understanding of the significance of nutrition in brain health, identify key nutrients and biomarkers related to cognitive function. Join us to see how nutrition science plays a larger role in the future of brain health research. 

Moderator: 

Caitlin Ondracek, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA 

Speaker: 

Gene Bowman, N.D. MPH Harvard Medical School, Investigator, Instructor, Mass General Research Institute. 

BREAKOUT #9:  Offshoring-Onshoring-Why, Where, What’s Next?

Tariffs and other strategic business decisions are leading manufacturers to consider the risks and benefits of offshoring, nearshoring, and onshoring. Several factors should be considered before making critical decisions, including logistics, regulations, labor costs, workforce skills, taxes, material availability, price, quality, time requirements, and global supply chain complexities. As the need and push for onshoring increases in the United States, one of CHPA’s expert members, Thomas Cook, CEO and Managing Director of Blue Tiger International, will be covering all details manufacturers of OTC medicines, OTC medical devices, and dietary supplements should consider in planning to onshore production at the upcoming Regulatory, Scientific and Quality (RSQ) conference.

Gain an understanding of the considerations for offshoring, nearshoring, and onshoring, the challenges faced by US over-the-counter, dietary supplements, and medical device manufacturers, and the implications of tariffs. The session will also provide insights into how global supply chains work, risk management strategies, vendor management, supply chain challenges, sourcing strategies, and other considerations.

Speaker: 

Tom Cook, Managing Director & CEO, Blue Tiger International 

10:00-10:15 A.M. 

Networking BREAK - 

10:15-11:15 A.M.

BREAKOUT #10: Innovative Approaches to E-Labeling for Medical Devices & OTC Drugs

(REGULATORY) Join us for an engaging session focused on the forward-thinking concept of e-labeling for medical devices. We will delve into how the FDA can adopt various forms of labeling beyond traditional print and discuss the advantages of implementing e-labeling systems. Discover the latest medical research highlighting the benefits of personalized labels and learn strategies for effectively messaging and designing products to facilitate the transition to e-labeling. This session aims to provide valuable insights and practical guidance to help advance this innovative approach in the medical device industry.

BREAKOUT #11: Oral Health and Self-Care: Exploring the Significance of Oral Health in Overall Well-Being

(SCIENCE) Join us as we delve into the critical importance of oral health as a cornerstone of self-care and full-body health. This session will feature distinguished speakers from renowned organizations, including the National Dental Association, and esteemed academicians specializing in holistic health. Representatives will discuss the latest initiatives and research on oral health and its impact on overall wellness.

BREAKOUT #12: TBA

 

11:30 A.M.-12:15 P.M. 

GENERAL SESSION: Dyes/Flavors/Additives 

Join us for a timely and insightful panel discussion, where we will delve into the  announcement by Health Secretary RFK Jr. and FDA Commissioner Dr. Marty Makary regarding the voluntary phase-out of FD&C colors from the food supply by the end of 2026. This session will explore the implications of this announcement, which does not equate to a ban, as the FDA has not provided new scientific evidence or taken any legal or regulatory actions to make such a limitation mandatory. We will also address the conflicting statements about the FDA's intent for drugs, with Dr. Makary initially including medicines in the phase-out, while later clarifications and the FDA website only mention food. Join our expert panel to discuss the current and future status of FD&C colors in food and medicine.

Speakers: 

Lisa Navarro, Ph.D., DABT ER, Principal, Health Sciences, Product Safety & Stewardship Business Development, Americas

Anthony T. Pavel, Partner, Keller and Heckman LLP

12:00-12:15 P.M. 

Closing remarks