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Consumer Healthcare 101

Registration is Open!

April 9-10, 2024
CHPA Headquarters
1625 Eye Street, NW, Suite 700
Washington, DC 20006

CH101 Seminar

 

Are you brand new to the Consumer Healthcare Industry and want to understand how the industry works? An industry professional looking for a refresher on the basics of Consumer Healthcare? A service provider who wants to better understand the Consumer Healthcare industry to effectively work with your clients?

CHPA’s Consumer Healthcare 101 (CH101) will equip you with the facts and tools you need to better understand the Consumer Healthcare industry in order to succeed. Whether you are brand new to the industry or interested in going “back to basics”, this seminar will cover:

  • The State of the Industry: Commercial Update 2023
  • FDA Oversight in Cosmetics & Update on MOCRA
  • OTC Drug Labeling Regulations
  • OTC Monograph Reform 
  • Rx-to-OTC Switch
  • Advertising 101 for Consumer Healthcare Products 
  • Medical Devices
  • Cosmetics & Dietary Supplements
  • Manufacturing & Product Quality 
  • and much more!

Inside CH101

 

Who should attend?

This course is is open to all CHPA members and nonmembers. Both entry-level and seasoned professionals are invited to attend. The course is suited for all job functions, including Business Development, Communications, Government Affairs, Legal, Marketing/Sales, Operations, Public Affairs, Quality, Regulatory, and R&D.

2024 Program (*Subject to Change)

April 9-10, 2024

April 9

Day 1

 

7:00-8:00 a.m.

Networking Breakfast

8:00-8:15 a.m.

Welcome & Overview

Beth Allgaier, SVP of Business Development, CHPA

8:15-9:15 a.m.

The State of the Industry: Commercial Update 2023

Circana will outline the sales size, key brands, manufacturers & marketers, retailers, consumer behavior and key trends for the industry in 2023. OTCs, medical devices, as well as supplements will be covered.

Speaker

Dennis Permar, Client Insights Consultant, Circana

9:15-9:45 a.m.

Health In Hand Foundation

Learn about the Foundation’s mission to empower consumers to make safe, informed decisions when choosing and using self-care products.

Speaker

Mary Leonard, Executive Director, Health in Hand Foundation

9:45-10:00 a.m.

Networking Break

10:00 a.m.-12:00 p.m.

FDA Oversight of Nonprescription Drug Products

The presentation will cover OTC Drug labeling requirements per 21 CFR 201.66. The importance of drug monographs will also be covered as well as some things that may change under the new OTC Drug Safety, Innovation & Reform Act.

Speaker 

Doug Bierer, President, Douglas Bierer Consulting, LLC

12:00 -1:00 p.m.

Networking Lunch

1:00 -2:00 p.m.

OTC Drug Labeling Regulations

The presentation will cover OTC Drug labeling requirements per 21 CFR 201.66. The importance of drug monographs will also be covered as well as some things that may change under the new OTC Drug Safety, Innovation & Reform Act.

Speaker

Daniel Keravich, Principal, Chesapeake OTC Regulatory Strategies, LLC

2:00-3:00 p.m.

OTC Monograph Reform

On March 27, 2020, Congress included landmark legislation to reform the OTC Monograph system in the COVID-19 response bill, the CARES Act. In this session, attendees will learn why reform was necessary, the key elements of policy reform covered by the legislation and FDA goals letter and how user fees will be assessed and fund reform activities at FDA.

Speaker

Jay Sirois, Vice President, Regulatory & Scientific Affairs, CHPA 

3:00-3:15 p.m.

Networking Break

3:15-4:45 p.m.

Rx-to-OTC Switch

An introduction to the commercial, scientific and regulatory considerations and challenges when converting a prescription drug to a consumer product for self-care. 

Speakers

Edwin (Ed) Hemwall, Principal, Edwin Hemwall LLC 

Marcia D. Howard, Vice President, Regulatory & Scientific Affairs, CHPA. 

5:00-6:00 p.m. 

Networking Reception

April 10

Day 2

7:00-8:00 a.m.

Networking Breakfast

8:00 – 9:00 a.m.

Medical Devices

An overview of FDA regulations and guidance related to safety, effectiveness, manufacturing, and claims applicable to medical devices.

Speakers

Marcia D. Howard, Vice President, Regulatory & Scientific Affairs, CHPA

Christina Kuhn, Special Counsel, Covington & Burling

9:00-10:00 a.m.

FDA Oversight in Cosmetics & Update on MOCRA

An overview of the FDA regulations related to safety, labeling, manufacturing and claims for cosmetics.

Speakers

Kelly Bonner, Associate, Duane Morris LLP

Mary Schilling, Assistant General Counsel at PCPC

10:00-10:15 a.m.

Networking Break

10:15-11:15 a.m.

Dietary Supplements

An overview of regulations related to safety, labeling, manufacturing and claims dietary supplements. Dr. Hu will address FDA Regulation of Dietary Supplements and Duffy MacKay will cover the industry’s role in product integrity, safety, and informed consumer decision making.

Speakers

Haijing Hu, Ph.D., Chief, Regulatory Implementation Branch, FDA Office of Dietary Supplements Programs (ODSP)

Duffy MacKay, N.D., Senior Vice President, Dietary Supplements, CHPA

 

11:15-11:45 a.m.

CHPA Public Affairs and Communications

A look at how OTCs, dietary supplements, and consumer medical devices are covered in the trade, consumer, and scientific media, and examples of how CHPA defends and promotes consumer healthcare issues, ingredients, and products.

Speaker

Mike Tringale, Senior Vice President, Communications, CHPA

11:45 -12:30 p.m.

Networking Lunch

12:30 - 1:45 p.m.

Advertising 101 for Consumer Healthcare Products

Overview or regulatory standards governing consumer health product advertising for OTC drugs, dietary supplements, and medical devices, including new guidance issued by the Federal Trade Commission regarding claim substantiation, social media, and use of influencers and lessons from the Food & Drug Administration and National Advertising Division of BBB National Programs.

Speaker

Raqiyyah Pippins, Partner, Arnold & Porter

1:45-2:45 p.m.

Manufacturing & Product Quality

A review of the top five deficiencies related to OTC medicines and dietary supplements identified during regulatory inspections plus learnings from recent FDA regulatory action. Our goal is to share some insight, potential solutions, and to inspire continuous improvement for your quality systems.

Speaker

Jen Ahearn, CEO, GMPACT

2:45-3:15 p.m. 

CHPA State and Federal Affairs Overview

Speaker 

Carolyn Herrmann, Deputy General Counsel, Legal, Government Affairs & Policy, CHPA

3:15 p.m.

Meeting Adjourns

Program questions

Our Expert Speakers

Jennifer D. Ahearn Headshot
Jen Ahearn
Director of Regulatory and Compliance, Engineering Systems Inc.

Ms. Ahearn specializes in pharmaceutical and medical device regulatory compliance. She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations relating to pharmaceutical manufacturing. Ms. Ahearn has assisted pharmaceutical, medical device, combination products, and dietary supplement companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms, medical devices, combination products and dietary supplements.

 

Beth Allgaier Headshot in black blazer and white shirt
Senior Vice President, Business Development and Industry Relations

Beth Allgaier, Senior Vice President of Business Development and Industry Relations and a member of CHPA Senior Management Team, is responsible for maintaining, developing, and expanding CHPA’s membership base; securing revenue streams through dues, sponsorships, meetings, and educational programming; promoting consumer self-care choice and availability in OTC medicine, dietary supplements, and consumer medical devices; and exceeding expectation and satisfaction with membership.  Additionally, Allgaier develops business-building partnerships with manufacturers and national retailers that lead to successful outcomes in the industry.

Prior to joining CHPA in 2020, Allgaier spent ten years in business development roles at the Society of Interventional Radiology (SIR) and the Melanoma Research Foundation (MRF), where she managed partnerships with medical device and pharmaceutical companies, as well as other corporate stakeholders. Moreover, Allgaier established her specialization in developing new membership strategies, creating greater communication and stewardship processes with industry partners, and ensuring revenue growth and organizational success by building lasting influential relationships. Allgaier’s career began in the pharmaceutical industry, managing sales teams and managed-care accounts at GSK and Sanofi, Inc.

Allgaier is a member of the American Society of Association Executives.

 

Doug Bierer Headshot
Doug Bierer
President, Douglas Bierer Consulting, LLC

Douglas (Doug) Bierer Ph.D. consults with the pharmaceutical industry on regulatory affairs, clinical design and development, claim support and product development issues for nonprescription drugs, prescription to over-the-counter (Rx-to-OTC) switches, homeopathic drugs, dietary supplements and cosmetic products. He acts as an advisor to client companies in strategic planning for Rx-to-OTC switches, FDA submissions and meeting preparation, and OTC monograph, NDA and ANDA drug, and cosmetic product issues. He has more than 35 years of experience in the drug industry in the areas of toxicology, regulatory affairs, and clinical development and has served in senior management level positions in the Procter & Gamble Company and CHPA.

 

Kelly Bonner Speaker
Kelly Bonner
Associate, Duane Morris LLP

Kelly Bonner, an associate at Duane Morris LLP, focuses on litigation risk and regulatory issues affecting businesses in the cosmetics and personal care industries, as well as cross-jurisdictional and complex commercial disputes involving FDA-regulated and consumer-branded products. (She has two little boys, and frightening collection of shoes and perfumes).

 

Ed Hemwall Headshot
Ed Hemwall, Ph.D.
Principal, Edwin Hemwall, LLC.

Edwin (Ed) Hemwall, Ph.D. brings over 40 years of industry experience to consulting services in OTC product development. He focuses on Rx-to-OTC switch, medical claims, regulatory strategy, and FDA Advisory Committee preparation. His prior industry career spanned a range of clinical and regulatory leadership roles with Merck, J&J, GSK and Bayer, retiring in 2016 as a VP on Bayer’s worldwide R&D team. Ed has published and lectured as a Switch and Self-Care advocate and has served on FDA’s Clinical Pharmacology and Pharmaceutical Sciences Advisory Committee, the Board of Directors of CHPA, and as Chair of CHPA’s Regulatory and Scientific Affairs Committee. In 2023 Ed was honored with the CHPA Regulatory and Scientific Career Achievement Award recognizing outstanding service and contributions to the consumer healthcare products industry having created long-lasting impacts in support of public health.

 

Carolyn Herrmann Headshot
Deputy General Counsel

Carolyn Herrmann is responsible for providing legal advice and recommendations to Association staff and members on key issues affecting the OTC, dietary supplement, and consumer medical device industries, representing industry interests on a range of food and drug law regulatory matters, assisting with Association policy development, and managing various industry projects through direct engagement with member company representatives.

Carolyn previously served in this role from 2012 through 2019. From 2019 – 2023 she worked as Associate General Counsel for Nestle Infant Nutrition, supporting the infant and toddler food, supplement and formula businesses and then as Deputy General Counsel, Standards at the U.S. Pharmacopeia in a global leadership team role.

Prior to initially joining CHPA in June 2012, she was an attorney at Shook, Hardy & Bacon LLP, practicing in the Pharmaceutical and Medical Device Litigation Division, where she focused primarily on counseling and defending product-liability actions against pharmaceutical and medical device manufacturers.

Carolyn is a member of the D.C. Bar Association and the Food and Drug Law Institute. She resides in Northern Virginia with her husband, three boys and two dogs.

 

Marcia Howard Headshot
Vice President, Regulatory & Scientific Affairs

As CHPA Vice President of Regulatory & Scientific Affairs, Marcia D. Howard, Ph.D., CAE, provides support to the Regulatory & Scientific Affairs Committee (RSAC), is the staff liaison for the Consumer Medical Device (CMD) Committee, and works to further policy objectives with the U.S. Food and Drug Administration (FDA) for drugs and medical devices. Howard assumed the role of scientific liaison for the CHPA Pediatric Cough Cold Task Group in 2009 and continues to lead this key initiative. She also assists with over-the-counter medicine issues and plays a critical role in coordinating the association’s annual Regulatory, Scientific & Quality Conference (RSQ). Howard coordinates many of CHPA’s internal and external meetings with members, regulators, and other stakeholders.

 

Haijing Hu Headshot
Haijing Hu
Chief of the Regulations Implementation Branch, Center for Food Safety and Applied Nutrition, FDA

Haijing Hu joined the FDA in 2010 and has served in several roles and positions. Her current role is the Chief of the Regulations Implementation Branch (RIB) in the Office of Dietary Supplement Programs (ODSP) within the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA. She leads a multi-disciplinary team to review industry submissions and inspectional findings on labeling and CGMP compliance. She also collaborates with other FDA offices in the development of compliance policies and enforcement actions. Haijing has been at this position for four years.

Prior to joining ODSP, Haijing was a senior microbiologist in CDER’s Office of Compliance with a focus on pharmacy compounding. She also conducted microbiological assessments for sterile drug manufacturing in CDER as well as sterilization and disinfection assessments for medical devices at CDRH.

Haijing obtained her Ph.D. in 2003 as a food microbiologist. She has more than 10 years of experience in microbiological research prior to joining the FDA.

 

Daniel Keravich Headshot
Daniel Keravich
Principal and Owner, Chesapeake OTC Regulatory Strategies LLC

Daniel P. Keravich is the Principal and Owner of Chesapeake OTC Regulatory Strategies LLC, a consumer healthcare consulting firm that specializes in providing regulatory strategies, solutions, and support to the OTC healthcare industry. His company specializes in helping sponsors with OTC Switch, providing regulatory affairs strategy and policy advice, and currently helps OTC companies with OTC monograph reform. He currently serves as a senior advisor role to CHPA on OTC Monograph reform for OMUFA II.

Mr. Keravich has over 35 years of pharmaceutical research and regulatory affairs experience including leadership roles at FDA within the OTC Division, NIH, and GSK Consumer Healthcare, now known as Haleon.

Mr. Keravich’s educational background includes:

  • A Master of Business Administration (MBA), from Loyola College, Sellinger School of Business and Management in Baltimore, MD.
  • A Master of Science from Massachusetts College of Pharmacy and Allied Health Professions in Boston, Massachusetts
  • A Bachelor of Science (BS), Pharmacy | Northeastern University College of Pharmacy and Allied Health Profession, Boston, Massachusetts

He also completed his Regulatory Affairs Certification (RAC) in May of 2011.

 

Christina Kuhn Headshot
Christina Kuhn
Senior Associate, Covington & Burling LLP

Christina Kuhn is a senior associate at Covington & Burling LLP, where she advises medical device, diagnostic, digital health, and life sciences companies on a broad range of FDA regulatory strategy and compliance matters for cutting edge medical technologies. She frequently helps clients successfully navigate the premarket regulatory process, advising companies on regulatory classification, product development, clinical strategy, and agency interactions. Christina also has significant experience counseling clients on postmarked compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, recalls, and FDA and DOJ enforcement actions. Christina also regularly assists clients on FDA policy matters, such as commenting on FDA guidance documents and rulemaking, as well as drafting and analyzing federal legislation. Her clients span early-stage start-ups to multinational companies and trade associations. She is a graduate of the New York University School of Law and holds Bachelor of Science degree from Princeton University.

 

Mary Leonard Headshot in black dress
Executive Director, Health in Hand Foundation

Mary Leonard is responsible for overseeing the strategic management of the association’s 501c3 educational foundation - Health In Hand - including its consumer education programming, alliance/partnership development, donor engagement and fundraising, strategic planning, board management, and serving as the main spokesperson. She is the lead on the organization's flagship campaigns Know Your Dose and Up and Away, and she also plans and executes Health In Hand's annual Gala.

Prior to transitioning to an educational foundation role in June 2017, Leonard led the development and implementation of CHPA's association integrated marketing communications programs and initiatives for six years. In this role, she provided strategic direction to the association's overall brand strategy through print, digital, and new media platforms elevating awareness about CHPA’s programs and strengthening relationships with members and stakeholders. Prior to joining CHPA, Leonard led the marketing programs for Associated Builders and Contractors and the Healthcare Distribution Alliance, both trade associations in the DC/Metro area.

Leonard lives in Arlington, Va., with her husband, Joe, and her sons, Owen and Henry. She serves on the National Poison Prevention Week Council and is a member of CHPA’s Diversity Equity and Inclusion Steering Team.

 

Dennis Permar Headshot
Dennis Permar
Consultant, Client Insights, Circana

Dennis Permar is a seasoned leader in consumer research and analytics, offering over 22 years of expertise in fostering strategic partnerships within the healthcare and CPG sectors. Since joining Circana (formerly IRI) in 2001, he has played a pivotal role in supporting various OTC brands. Throughout his career, Permar has accumulated extensive experience across consumer healthcare’s $1B+ categories, showcasing his passion for excellence and strategic acumen in the dynamic landscape of consumer research and analytics.

During his tenure, Permar led the integration of a prominent pharmaceutical company’s Consumer Healthcare division, navigating challenges such as product repositioning and preparing the company for its Rx to OTC launch of a well-known allergy medicine. Subsequently, he dedicated a decade to supporting a leading healthcare business, successfully helping them navigate market challenges and the tumultuous impact of the COVID-19 pandemic.

In his current role at Circana, Permar is a key contributor and thought leader, supporting diverse brands and collaborating with marketing and research leaders to enhance business outcomes. His focus is on driving brand stability and growth, reflecting his commitment to tangible results.

 

Raqiyyah Pippins Headshot
Raqiyyah Pippins, Esq.
Partner, Arnold & Porter

Raqiyyah Pippins co-leads the firm's Consumer Products Practice Group and the Consumer Products & Retail Industry Team. She has extensive experience representing companies that are engaged in the development, marketing, import, and export of consumer products, including FDA-regulated consumer products, apparel, appliances, and devices. Raqiyyah focuses her practice in the areas of FDA's regulation of food, dietary supplement, cosmetic, drug and medical-device products sold directly to consumers as well as FTC and state regulation of the marketing and sale of consumer products. She collaboratively partners with litigation teams to defend clients against consumer litigation demands alleging unfair and deceptive advertising practices. She also routinely represents consumer product companies in advertising challenges before the National Advertising Division (NAD) of the Better Business Bureau National Programs and defends companies in investigations conducted by the FDA, FTC, and state agencies regarding product marketing practices.

Raqiyyah has particular experience assisting companies develop promotional strategies that account for the federal and state regulations governing direct-to-consumer product promotion. Her experience includes advising consumer product companies on relevant federal and state laws and regulations governing health-related, performance, and sourcing claims (e.g., natural, organic, and green claims) for apparel, conventional food, dietary supplements, cosmetics, and devices; assisting FDA-regulated companies with product development, monograph compliance, and Rx-to-OTC switches; and counseling companies regarding the development of clinical and sensory studies intended to substantiate advertising claims. She is a trusted advisor of trade organizations supporting manufacturers of FDA-regulated products regarding FTC and state standards that also impact the risk profile for companies' product portfolios, and is regularly invited to work directly with clients' marketing and research and development teams to help identify marketing strategies that are consistent with the desired risk threshold for the company. According to clients, she is "excellent at crafting solutions that ensure regulatory compliance within the business context, helping to provide practical advice that takes into consideration the way in which a business operates."

 

Duffy MacKay Headshot
Senior Vice President, Dietary Supplements

Duffy MacKay, ND, is the Senior Vice President of Dietary Supplements at the Consumer Healthcare Products Association (CHPA), where he leads the association’s dietary supplement scientific, policy and legislative initiatives. Dr. MacKay’s career in supplements spans over 25 years and includes serving as a senior executive and scientist at leading dietary supplement companies, including CV Sciences, Nordic Naturals, and Thorne Research. In addition, he worked for 10 years with the Council for Responsible Nutrition (CRN) in Washington, D.C., where he served as Senior Vice President of Scientific & Regulatory Affairs and led the association’s scientific and regulatory affairs department. He is also an editor for the Natural Medicine Journal and Integrative Medicine: A Clinician’s Journal, and an associate editor for the Journal of Dietary Supplements and serves on the Advisory Board for the American Botanical Council. Dr. Mackay started his career as a naturopathic doctor working in a private medical practice. He earned his naturopathic medical degree from the National University of Natural Medicine in Portland, Oregon, and his undergraduate degree in Marine Biology from the University California Santa Cruz.

 

Mary Schilling Headshot
Mary Schilling
Assistant General Counsel, Personal Care Products Council

Mary Schilling is Assistant General Counsel at the Personal Care Products Council (PCPC), which is the premier trade association for the global cosmetics and personal care products industry. PCPC’s 600 member companies represent a $529.3 billion industry and include approximately 90% of the U.S. beauty industry. Mary provides counsel on legal and regulatory issues across the industry, particularly on the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Prior to her time at PCPC, Mary worked as an attorney for the American College of Obstetricians and Gynecologists (ACOG). In addition to her legal expertise, Mary brings over a decade of experience navigating the federal legislative system both on the Hill and as an advocate, including work as Political and Advocacy Director at ACOG, a legislative staffer in the office of Senator Chris Murphy, and a senior staffer on multiple U.S. Senate campaigns. Mary is a member of the DC Bar Association and a graduate of Georgetown Law and Cornell University. She resides in Takoma Park, MD with her husband and young son.

 

Jay Sirois Headshot
Vice President, Regulatory & Scientific Affairs

Jay Sirois is responsible for regulatory and scientific affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and dietary supplement programs at CHPA.

Prior to joining CHPA in October 2011, Sirois was employed at Pharmaceutical Development Group as director, Scientific Research and Clinical Studies. He is experienced in pharmaceutical, medical device, and dietary supplement regulatory affairs, pharmacovigilance, Rx-to-OTC switch, product safety, and clinical research.

 

Mike Tringale Headshot
Senior Vice President, Communications & Public Affairs

Mike Tringale is responsible for providing strategic direction and oversight for external and member communications, media relations, strategic ally development, and key public affairs initiatives.

Prior to joining CHPA in January 2016, Tringale served as senior vice president of external affairs at the Asthma and Allergy Foundation of America (AAFA) for more than a decade, where he led development, public affairs, and public relations. He managed AAFA’s partnerships with Global 2000 companies in sectors such as pharmaceuticals, consumer products and manufacturing, directed consumer research, and developed the Asthma & Allergy Friendly™ Certification Program.

Prior to AAFA, Tringale worked at the Brookings Institution, Georgetown University Medical Center, MHI Global/Huthwaite Consulting, and W.J. Kircher Associates, an advertising, marketing, and public relations firm serving trade associations.

Tringale is a member of the American Marketing Association, recently serving as chair of the DC chapter nonprofit section, and he is a member of the Public Relations Society of America.

 

Registration

How to Register 

  • Member fee:  $995
  • Nonmember Fee:  Please contact  meetings@chpa.org. 

Register online. Phone registrations are NOT accepted.

Register 

 

Registration Questions

 

 

Housing & Transportation

Hotel Information

If you need housing, we recommend these, which are in close proximity to our building on 1625 Eye Street, NW, Washington, DC 20006.  Suggested hotels include:

  1. Hotel St. Regis-Washington-DC
  2. The Hyatt Place Washington DC
  3. Hilton Garden Inn Washington DC Downtown
  4. Sofitel Washington DC Lafayette Square
Travel Logistics

Airport Information

Ronald Reagan Washington National Airport, referred to colloquially as National Airport, Reagan, Reagan National, or simply DCA, is an international airport in Arlington County, Virginia, across the Potomac River from Washington, D.C.  

Ground Transportation

DCA is 6.0 miles from CHPA (a 25-minute ride)  

Farragut West Metro Station is one block away.

Parking

Self-parking is available in the building.