2021 RSQ Hero Banner

It's Not too Late to Register for RSQ 2021

Didn't attend RSQ live? You can still register to view recorded sessions until October 10th!

About RSQ

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.

Select 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 September 10)

September 9-10, 2021

Important Information!

Attendee Tutorial

The conference will begin at 10 am (EDT) sharp on Thursday, September 9th, so be sure to log in early to get acquainted with the virtual platform. Click here to view a quick tutorial. 

Sept. 9, 10:00 a.m.

Welcome Remarks

Barbara Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association (CHPA)

Julia Kim, Head Regulatory Health North America, Reckitt

Sept. 9, 10:05-10:45 a.m.

General Session

Moderators: Scott Melville, President and CEO, CHPA; Barbara Kochanowski, Senior Vice President, Regulatory & Scientific Affairs, CHPA

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.

Sept. 9, 10:45-11:00 a.m.

Morning Break

Sept. 9, 11:00-12:00 p.m.

General Session: The Consumerization of Health Care

Moderators: Evren Atillasoy, M.D., Senior Director, Head of U.S. Medical Affairs, Johnson & Johnson Consumer, Inc.; Mike Tringale, MSM, MSc., 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 of 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. 

Sept. 9, 12:00-1:00 p.m.

Lunch Break

Sept. 9, 1:00-2:30 p.m.

Breakouts

CBD - Regulatory, Legislative and Scientific Insights

Dietary Supplements

Moderator: Marc Schloss, Vice President, Federal Government Affairs, 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

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; 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.

 

Sept. 9, 1:00-3:00 p.m.

Considerations for the Future of Rx-to-OTC Switches

Regulatory

Moderator: David Spangler, J.D., Senior Vice President, Legal, Government Affairs & Policy, CHPA

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 E. Becker, M.D., FACP, Director, Division of Nonprescription Drugs II, Office of Nonprescription Drugs, U.S. Food and Drug Administration

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.

Sept. 9, 2:30-3:00 p.m.

Afternoon Break

Sept. 9, 3:00-4:00 p.m.

Breakouts

Improving Environmental Sustainability in Our Business

Quality

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. Reckitt has announced ambitious sustainability goals across products, packaging, the environment, and society and will speak about their journey to these 2030 targets.  Attendees will hear case studies of sustainability programs developed to drive leading environment and social performance with examples of sustainability strategies, meaningful sustainable supply chains, optimized products and sustainable packaging.

Probiotics in 2021 - Science, Regulation, and Marketplace

Dietary

Speakers: George Paraskevakos, Executive Director, International Probiotics Association; 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.

 

Sept. 9, 3:15-4:00 p.m.

Maximizing Your FDA Project Manager/Sponsor Interactions

Regulatory

Moderator: Celia Peacock, MPH, RD, Director, Regulatory Project Manager Staff, U.S. Food and Drug Administration

Speaker: CAPT. Dan Brum, PharmD, MBA, BCPS, Chief, Project Management Staff, U.S. Food and Drug Administration

Panelists: Elizabeth Thompson, MS, Chief, Project Management Staff, U.S. Food and Drug Administration; Trang Tran, PharmD, U.S. Food and Drug Administration; Anna Thai, PharmD, U.S. Food and Drug Administration

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.

Sept. 9, 4:00-5:30 p.m.

Breakouts

DSHEA 2.0 - This will be a LIVE session ONLY, and will not be available to view post-conference.

Dietary Supplements

Moderator: Russell Michelson, Global Regulatory Head, VMS, Reckitt

Speakers: Liz Richardson, Project Director, Pew Charitable Trusts; Diane McEnroe, J.D., Partner, Sidley Austin, LLP; Angela Wiles, Health Policy Director, U.S. Senator Richard Burr; Marc Schloss, Vice President, Federal Government Affairs, CHPA

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

Regulatory

Moderators: Verna Mecadon, Director, Regulatory Affairs, Bayer; Wade Ackerman, J.D. Partner, Covington & Burling

Speakers: Jenna Phillips, MSc., Principal Consultant, PA Consulting; Sonja Fulmer, Ph.D., Assistant Director for Digital Health Policy, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Peter J. Yang, Ph.D., Policy Analyst, De Novo Program Lead, 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

Quality

Moderator: Catherine Vicente, Enterprise Regulatory Outreach Manager, Johnson & Johnson Consumer, Inc.

Speakers: Tara Lin Couch, Senior Director, Dietary Supplements and Tobacco, EAS Consulting Group, LLC; Steven A. Greer, Senior Consultant and Business Development, Pharmaceutical & Medical Devices, ESi

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.

 

Sept. 9, 5:30-6:30 p.m.

Networking Event

Sept. 10, 9:30-10:30 a.m.

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, CFSAN, U.S. Food and Drug Administration; Jonette R. 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. 

Sept. 10, 10:30-12:00 p.m.

Breakouts

Can We Say That?...Lessons in Advertising During COVID-19

Regulatory

Moderator: Meghan Leonardi, Regulatory Manager, Reckitt

Speakers: Renuka Singh, J.D., Senior Legal Counsel, Regulatory, 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 particularly vulnerable to unreliable information. Two regulatory legal experts 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 in our post-pandemic world.     

Impurities

Quality

Moderator: John Brown, Senior Director of Quality, Perrigo Company

Speakers: David Light, Founder and CEO, Valisure; Amy L. Roe, Principal Scientist, The Procter & Gamble Company; Antonio Hernandez-Cardoso, Principal Scientist, The United States Pharmacopeial Convention, Inc.

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

Dietary Supplements

Moderator: Jay Sirois, Senior Director, Regulatory & Scientific Affairs, CHPA

Speakers: Claire Kruger, Ph.D., Managing Partner, Spherix Consulting Group, Inc.; Scott Bass, J.D., Partner, Head, Global Life Sciences, Sidley Austin; Sibyl Swift, Ph.D., Vice President, Scientific & Regulatory Affairs, cbdMD, Inc.

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.

 

Sept. 10, 12:00-12:30 p.m.

Lunch Break

Sept. 10, 12:30-2:00 p.m.

Breakouts

The "Why" & "How" Behind Selecting an OTC Drug Product Name

Regulatory

Moderators: Arjun Channi, Associate Director, Global Regulatory Affairs Team Lead, Sanofi Consumer Healthcare; Meghan Leonardi, Regulatory Manager, Reckitt

Speakers: Julie Aker, MT (ASCP) President & CEO, Concentrics Research; Danielle Harris, PharmD, BCPS, DMEPA Deputy Director, U.S. Food and Drug Administration; Arjun Channi, Regulatory Affairs Director, Sanofi Consumer Healthcare; 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.

Nitrosamines

Quality

Moderator: Neil Stiber, Associate Director for Science and Communication, CDER/OPQ/Office of Quality Surveillance, U.S. Food and Drug Administration

Speaker: Dongmei Lu, Ph.D., Senior Policy Lead, U.S. Food and Drug Administration; Jason Rodriguez, Ph.D., Director, Division of Complex Drugs, U.S. Food and Drug Administration; Jennifer Nette, Senior Manager, Analytical R&D, New Product Development, Perrigo Company

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 and 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)

Dietary Supplements

Moderator: Catherine Vicente, Enterprise Regulatory Outreach Manager, Johnson & Johnson Consumer, Inc.

Speakers: David Trosin, Managing Director, NSF International; Kyle Garner, General Manager, Naturals Portfolio, Bayer Consumer Health; Allyn Shultis, Executive Director, Global Retailer and Manufacturer Alliance, Inc.

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.

 

Sept. 10, 2:00-3:30 p.m.

Closing General Session: FDA and USP Leadership

Moderator: Barbara Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA

Speakers: Theresa Michele, M.D., Director, Office of Nonprescription Drugs, Office of New Drugs, CDER, U.S. Food and Drug Administration; Donald D. Ashley, J.D., Director, Office of Compliance, CDER, U.S. Food and Drug Administration; Jaap Venema, Ph.D., Executive Vice President & Chief Science Officer, The United States Pharmacopeial Convention, Inc.

FDA and USP leaders will provide updates on their organizations and priorities and will take questions from the attendees.

 

Sept. 10, 3:30-4:00 p.m.

Closing/Wrap Up

Speaker: Julia Kim, Head Regulatory Health North America, Reckitt

Available Sept. 3, 2021

On Demand Content

CHPA Academy

Speaker: Beth Allgaier, Senior Vice President, Business Development and Industry Relations, CHPA

CHPA Educational Foundation: Advancing Safe and Responsible Use

Speakers: Mary Leonard, Managing Director, CHPA Educational Foundation, CHPA; Kelsey Saylors, Senior Digital Content & Campaign Manager, CHPA Educational Foundation, CHPA

CHPA State Government Affairs Update

Speaker: Carlos Gutierrez, Vice President, State & Local Government Affairs, CHPA

CHPA Federal Government Affairs Update

Speaker: Marc Schloss, Vice President, Federal Government Affairs, CHPA

Consumer Medical Device Committee Chair Report

Speaker: Kathleen Blieszner, Ph. D., Global Product Stewardship, Regulatory Affairs, FemCare, The Procter & Gamble Company

Dietary Supplement Committee Chair Report

Speaker: Kathy Kramp, Senior Scientist - Regulatory Affairs, The Procter and Gamble Company

Product Quality and Manufacturing Committee Chair Report

Speaker: Catherine Vicente, Enterprise Regulatory Outreach Manager, Johnson & Johnson Consumer, Inc.

Regulatory & Scientific Affairs Chair Report

Speaker: Valerie Gallagher, Vice President, CSCA Regulatory Affairs, Perrigo Company

A Practical Process to Maximize your FDA Meetings

Speaker: Rachael Roehrig, Ph.D., Consultant, 3D Communications

A Snapshot of Supply Chains for Over-the-Counter (OTC) Monograph Drugs Products

Speaker: Mihir Jaiswal, Operations Research Analyst, Office of Quality Surveillance, U.S. Food and Drug Administration

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

International Updates (Canada)

Speaker: Kristin Willemsen, Vice President, Scientific & Regulatory Affairs Food, Food, Health & Consumer Products of Canada

OTC cGMP Inspection Trends

Speaker: Bryan Coleman, Senior Director, Pharmaceutical & Device Consulting Services, EAS Consulting Group, LLC

Titanium Dioxide (E171) - Developments in Europe and Potential Impact on Dietary Supplements, Pharmaceuticals and Cosmetics

Speaker: David R. Schoneker, President, Owner, Consultant, Black Diamond Regulatory Consulting, LLC

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 view all programming content (general sessions, breakouts, and on-demand) for 30 days post-conference.
  • Access to all on-demand content on September 3, 2021

$695 Member Registration Fee

$1295 Non-Member Registration Fee

$115 Government Registration Fee

$495 Nonprofit Registration Fee

$195 Full-time Student Registration Fee

Register Today

Online registration

  • 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. 

Save the Date for RSQ 2022

September 20-21, 2022
Hyatt Regency Bethesda

Staff Contact