CHPA’s Regulatory, Scientific & Quality Conference (RSQ) brings together leaders from industry, regulatory authorities, and academia across the consumer healthcare landscape to focus on the self-care space.
The RSQ agenda offers something for everyone with key legal, regulatory and scientific, and product quality sessions over the course of two days. Hear from FDA, USP, industry, and academia on some of the timeliest topics affecting the consumer healthcare marketplace.
Click on the Program tab for more information about the 2021 RSQ Program of Events. You may find additional information about the 2021 schedule of events here.
Embracing Change | Advancing Self-Care
Our industry and we as individuals are forever changed because of the pandemic.
Change has been a lifestyle over the last year. Worldwide interest in maintaining and managing health expanded rapidly, a trend driven by increased use of self-care products and technologies. What changes are here to stay? Are even more changes in store for our industry in the years ahead? This year's program will offer some ideas about this theme.
Program of Events (Last Updated July 22)
September 9-10, 2021
Barbara Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association (CHPA)
Julia Kim, Head Regulatory Health North America, Reckitt
Speaker: Janet Woodcock, M.D., Acting Commissioner, U.S. Food and Drug Administration
Dr. Woodcock will provide remarks on FDA priorities with an emphasis on self-care. She will also take questions from attendees.
General Session: The Consumerization of Health Care
Moderators: Evren Atillasoy, M.D., Senior Director, North America Medical/Clinical Affairs, Johnson & Johnson Consumer, Inc.; Mike Tringale, Vice President, Communications & Public Affairs, CHPA
Speaker: John Whyte, M.D., Chief Medical Officer, WebMD
The COVID pandemic has accelerated the changes that allow consumers to take control of their care. From the use telehealth to digital tools, including wearable, trackers, and sensors -- consumers are now empowered to help manage their own care. In order to do this effectively, credible useful information is key. The shift has begun from a physician-centric focus to a consumer-centric one.
- CBD - Regulatory, Legislative and Scientific Insights
Moderator: David Spangler, J.D., Senior Vice President, Legal, Government Affairs & Policy, CHPA
Speakers: Duffy MacKay, N.D., Senior Vice President, Scientific & Regulatory Affairs, CV Sciences, Inc.; Pete Meachum, Senior Director Government Affairs, Chronos Group; Rend Al-Mondhiry, J.D., Partner, Amin Talati Wasserman
Attendees will get the latest updates on the science behind CBD and related cannabinoids, proposed state and federal legislative efforts seeking to regulate CBD, and insights on how FDA is thinking regarding the use CBD and cannabinoids in food and dietary supplements.
- Advancing Product Quality
Moderator: Nelson Webb, Director, QA External Engagement, The Procter & Gamble Company
Speakers: Jennifer Maguire, Deputy Director, Office of Quality Surveillance, U.S. Food and Drug Administration (invited); Tami Frederick, Senior Director, Corporate Quality Systems & Cultural Excellence, Perrigo Company
This session will cover ISPE’s Advancing Pharmaceutical Quality Program developed to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System. The Advancing Pharmaceutical Quality (APQ) Program provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System using the new APQ Assess, Aspire, Act, and Advance Framework. FDA will provide updates on the FDA Quality Metrics programs (Site Visit and Feedback Programs) as well as the Quality Management Maturity Pilot program. Both speakers will share insights on the latest pharmaceutical industry operational excellence benchmarks, and practical strategies for building a corporate culture to support enhanced quality outcomes that go beyond compliance.
Considerations for the Future of Rx-to-OTC Switches
Speakers: Bernie Simone, Vice President of Client Strategy and Rx-to-OTC Switch, Pinney Associates; Clark Richardson, MPH, President & CEO, PEGUS Research, Inc.; Mary Alice Lawless, Founder and Chief Client Officer, Biograph Inc.; Francis Becker, M.D., FACP, Director, Division of Nonprescription Drugs II, Office of Nonprescription Drugs, U.S. Food and Drug Administration (invited)
This session will explore how changes in healthcare will influence future switches, learnings from decentralized consumer research and regulatory perspectives on successfully navigating future switch applications.
- Improving Environmental Sustainability in Our Business
Moderator: Adi Dinge, R&D Project Management Allergy, Cough & Cold, Pain & Cardio, Bayer
Speakers: Jennifer Duran, Global Director Product Sustainability, Reckitt; Cheryl Baldwin, Ph.D., Vice President of Sustainability Consulting, Pure Strategies
This session provides a forum for discussions centered on environmental sustainability and offers an opportunity to hear about environmental sustainability goals. Attendees will hear from the industry about how to meet the challenges of communicating, studying, and manufacturing for the current landscape. GSK has announced ambitious new environmental sustainability goals in both climate and nature, aiming to have a net-zero impact on climate and a net positive impact on nature by 2030.
- Probiotics in 2021 - Science, Regulation, and Marketplace
Speakers: George Paraskevakos, Executive Director, IPA; Mary Ellen Sanders, Ph.D., Consultant, Dairy & Food Culture Technologies
Probiotic products are increasingly being used for a number of possible health benefits. In this session, experts in the field will cover the most recent science supporting the use of probiotics for a number of different conditions as well as discuss important aspects for the determination of probiotic quality.
Maximizing Your FDA Project Manager/Sponsor Interactions
Moderators: Marcia D. Howard, Ph.D., CAE, Vice President, Regulatory & Scientific Affairs, CHPA; Dan Brum, PharmD, MBA, BCPS, Chief, Project Management Staff, U.S. Food and Drug Administration (invited)
Speakers: Celia Peacock, MPH, RD, Director, Regulatory Project Manager Staff, U.S. Food and Drug Administration (invited); Elizabeth Thompson, MS, Chief, Project Management Staff, U.S. Food and Drug Administration (invited)
Companies marketing OTC medicines under an approved application (abbreviated new drug application or new drug application) know the importance of having an effective, professional relationship with their FDA project manager. The Agency has issued guidance outlining procedures for regulatory activities like submitting meeting requests and labeling changes. But operationalization of these procedures may vary from one company to the next. Join this session to hear ways designed to enhance regulatory interactions between FDA and industry.
- DSHEA 2.0
Moderator: Russell Michelson, Global Regulatory Head, VMS, Reckitt
Speakers: Liz Richardson, Project Director, Pew Charitable Trusts (invited); Diane McEnroe, J.D., Partner, Sidley Austin, LLP
As the use of dietary supplements increases amongst consumers, modernization of DSHEA has been a hot topic of discussion. Attendees of this session will get the latest updates from industry and other stakeholders at the forefront of legislative discussions regarding where these efforts may be headed.
- Innovation Opportunities in Consumer Self-Care
Moderator: Verna Mecadon, Director, Regulatory Affairs, Bayer
Speakers: Sonja Fulmer, Ph.D., Assistant Director for Digital Health Policy, Center for Devices and Radiological Health, U.S. Food and Drug Administration
In the fall of 2020, FDA established its new Digital Health Center of Excellence (DHCoE) with the goal of empowering stakeholders to their pursuit of advancements in digital health. The pandemic has highlighted the importance of innovative selfcare products as COVID-19 diagnostic test kits are now available OTC under FDA emergency use authorization (EUA). Innovations in in vitro diagnostic devices could expand how consumers manage their healthcare, either alone or as part of OTC switch programs. During this session, an overview of the market landscape from medical devices used in the selfcare setting will be provided. Manufacturers will learn how to integrate DHCoE resources into their R&D programs. Experts will also highlight the various regulatory pathways available to bring OTC medical devices to market, including De Novo classification for devices.
- Remote Quality Evaluations
Moderator: Catherine Vicente, Enterprise Regulatory Outreach Manager, J&J
Speakers: Brian Hasselbalch, Consumer Safety Officer, U.S. Food and Drug Administration (invited); Bryan Coleman, Senior Director, Pharmaceutical & Device Consulting Services, EAS Consulting Group, LLC; Tara Couch, Senior Director, Dietary Supplements and Tobacco, EAS Consulting Group, LLC
This session will consist of a discussion of experience with quality assessments conducted remotely, lessons learned, and some perspectives on the future assessment process and potential for hybrid evaluations. Speakers from industry will address issues applicable to CMO’s and external suppliers followed by a panel Q and A with representatives of FDA Office of Regulatory Affairs and FDA Office of Product Quality.
FDA Leadership General Session
Moderators: Jay Sirois, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA; Marcia D. Howard, Ph.D., CAE, Vice President, Regulatory & Scientific Affairs, CHPA; Kristin Davenport, J.D., Counsel, Covington & Burling
Speakers: Cara Welch, Ph.D., Acting Director, Office of Dietary Supplement Programs, U.S. Food and Drug Administration (invited); Jonette Foy, Ph.D., Deputy Office Director, Office of Policy, CDRH, U.S. Food and Drug Administration
During the COVID-19 pandemic, the importance of self-care was magnified. Consumers purchase products as part of their self-care regimen, often without awareness of whether they are purchasing an OTC medicine, dietary supplement, or medical device. CHPA’s 2020 vision expanded the association’s representation to include consumer medical devices as well as OTC medicines and dietary supplements. Leaders from FDA’s Center for Food Safety & Applied Nutrition (CFSAN) and Center for Devices and Radiological Health (CDRH) will update attendees on Center staffing, key accomplishments and challenges, and top priorities in the coming year for dietary supplements and medical devices, respectively.
- FTC Enforcement in a COVID-19 World & Beyond
Moderator: Meghan Leonardi, Regulatory Manager, Reckitt; Anne Marie Murphy, Deputy General Counsel, CHPA
Speakers: Renuka Singh, Senior Regulatory Counsel, Reckitt; Raqiyyah Pippins, J.D., Partner, Arnold & Porter
Manufacturers of healthcare products answered the call when the COVID-19 pandemic was at its height. Health claims on product packaging and ads were key to helping consumers select products appropriate for their needs, especially during the medical crisis. The Federal Trade Commission (FTC) played, and continues to play, an important role protecting consumers from misleading ads and false claims about products when they may be particularly vulnerable to unreliable information. Hear from leadership at the FTC about its staffing and priorities under the new administration, operational efficiencies implemented due to the pandemic, and targeted enforcement efforts for self-care products. As part of this session, regulatory counsel will use case studies to illustrate ways companies have run afoul of FTC regulations and share points to consider when developing regulatory compliance programs and to avoid challenges from competitors.
Moderator: John Brown, Senior Director of Quality, Perrigo
Speakers: David Light, Founder and CEO, Valisure; Amy Roe, Principal Scientist, The Procter & Gamble Company; Antonio Hernandez-Cardoso, Principal Scientist, USP
Impurities in a drug substance or a drug product can arise due to synthetic/manufacturing processes, degradation, storage conditions, container, excipients, or contamination. This session will cover three current topics in drug impurities; recent findings of contamination in consumer products, an industry wide approach to degradant qualification, and a new USP chapter that has been created to align with current scientific and regulatory approaches and to help ensure the appropriate control of organic impurities and degradation products in drug substances and drug products.
- Safety Standards for Dietary Ingredients
Moderator: Jay Sirois, Senior Director, Regulatory & Scientific Affairs, CHPA
Speakers: Claire Kruger, Ph.D., Managing Partner, Spherix Consulting; Scott Bass, J.D., Partner, Sidley Austin
Dietary ingredients added to dietary supplements must have evidence of safety before they can be marketed. Uncertainty with aspects of these safety substantiation processes has led to confusion. In this session, you will hear from industry and FDA experts on the standards underlying the New Dietary Ingredient Notification and the Generally Recognized as Safe (GRAS) pathways, how these are utilized, and suggestions to improve these processes.
- The "Why" & "How" Behind Selecting an OTC Drug Product Name
Speakers: Julie Aker, MT (ASCP) President & CEO, Concentrics Research; Danielle Harris, PharmD, BCPS, DMEPA Deputy Director, U.S. Food and Drug Administration (invited); Arjun Channi, Regulatory Affairs Director, Sanofi; Meghan Leonardi, Regulatory Manager, Reckitt
The product name on the principal display panel (PDP) of OTC drugs, along with other key information, helps consumers choose the appropriate products to treat their symptoms. In December 2020, FDA released draft guidance outlining best practices for developing a proprietary name for OTC drug products. During this session, audience members will learn about the role of the FDA CDER’s Division of Medication Error Prevention & Analysis (DMEPA) plays in OTC product naming as part of its regulatory oversight for drugs sold under an approved application. Industry experts will provide an overview of study techniques designed to enhance consumers’ ability to discern one OTC product from another.
Moderator: Neil Stiber, Associate Director, CDER, OPQ, U.S. Food and Drug Administration (invited)
Speakers: Aloka Srinivasan, Principal & Managing Partner, RAAHALLC; Sue Zuk, Branch Chief, U.S. Food and Drug Administration (invited)
The discovery of nitrosamine impurities in some drug products is a recent concern, and the FDA along with health authorities around the world have been taking proactive efforts to help ensure drugs can be free from unsafe levels of these impurities. The industry is actively assessing the risk of nitrosamine impurities in APIs, marketed products. Where a manufacturer has determined an API or drug product is at risk, they have been conducting confirmatory testing for the presence of nitrosamine impurities. Developing accurate risk assessments of exposures and the determination of hazards continues to be challenging. This session brings together industry and FDA to share current thinking for risk assessment.
- Dietary Supplements Retailer Quality Programs (GRMA, NSF, UL)
Moderator: Catherine Vicente, Enterprise Regulatory Outreach Manager, J&J
Speakers: David Trosin, Managing Director, NSF; Kyle Garner, VP and General Manager NA, Naturals Portfolio, Bayer
A number of retailers are requiring dietary supplement manufacturers to submit products for third-party testing prior to being allowed on the shelf. Hear from expert stakeholders from industry, retail, and lab testing facilities on the standards that must be met as well as potential challenges associated with different requirements.
Closing General Session: FDA Leadership
Moderator: Barbara Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA
Speakers: Theresa Michele, Director, Division of Nonprescription Drug Products, Office of Drug Evaluation IV, CDER, U.S. Food and Drug Administration (invited); Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (invited); Jaap Venema, Ph.D., Executive Vice President & Chief Science Officer, USP
FDA leadership will provide updates on their organizations and priorities and will take questions from the attendees.
Speaker: Julia Kim, Head Regulatory Health North America, Reckitt
On Demand Content
International Updates (Canada)
Speaker: Kristin Willemsen, Vice President, Scientific & Regulatory Affairs Food, Health & Consumer Products of Canada
RSAC Chair Report
Speaker: Valerie Gallagher, Vice President Consumer Self-Care Americas, Regulatory Affairs, Perrigo Company
PQMC Chair Report
Speaker: Catherine Vicente, Enterprise Regulatory Outreach Manager, J&J
CMD Chair Report
Speaker: Kathleen Blieszner, Ph. D., Global Product Stewardship, Regulatory Affairs, FemCare, The Procter & Gamble Company
CHPA Education Foundation
Speakers: Mary Leonard, Managing Director, CHPA Educational Foundation, CHPA; Kelsey Saylors, Senior Digital Content & Campaign Manager, CHPA Educational Foundation, CHPA
Speaker: David Schoneker, President, Owner, Consultant, Black Diamond Regulatory Consulting, LLC
A Practical Process to Maximize your FDA Meetings
Speaker: Rachel Roehrig, Ph.D., Consultant, 3D Communications
CHPA Federal Government Affairs Update
Speaker: Carlos Gutierrez, Vice President, State & Local Government Affairs, CHPA
CHPA State Government Affairs Update
Speaker: Marc Schloss, Vice President, Federal Government Affairs, CHPA
Speaker: Beth Allgaier, Senior Vice President, Business Development and Industry Relations, CHPA
OTC cGMP Inspection Trends
Speaker: Bryan Coleman, Senior Director, Pharmaceutical & Device Consulting Services, EAS Consulting Group, LLC
CDC/PROTECT Initiatives Update
Speakers: Dan Budnitz, M.D., Director, Medication Safety Program, Division of Healthcare Quality Promotion, U.S. Centers for Disease Control and Prevention
A Snapshot of Supply Chains for Over-the-Counter (OTC) Monograph Drugs Products
Speaker: Mihir Jaiswal, Visiting Associate, U.S. Food and Drug Administration (invited)
How to Register for the 2021 Regulatory, Science & Quality Virtual Conference
Registration for the CHPA 2021 RSQ is only available online and includes:
- Virtual Participation in the September 9-10, 2021 Virtual Conference.
- Access to all on-demand content on September 8, 2021
$695 Member Registration Fee
$1295 Non-Member Registration Fee
$115 Government Registration Fee
$495 Nonprofit Registration Fee
$195 Student Registration Fee
- A login and password are required to register online
- New to CHPA? You must create an account first
Registration & Logistics Questions
Cancellation Policy: There are no refunds for cancellations, but substitutions are allowed through Friday, September 2, 2021.