Consumer Healthcare 101

Looking to dive into the Consumer Healthcare Industry, refresh your knowledge, or enhance your client interactions? CHPA’s Consumer Healthcare 101 (CH101) is the perfect resource for you! This two day  workshop equips you with essential insights and tools to thrive in the Consumer Healthcare sector. Whether you're a newcomer or seeking to revisit the fundamentals, CH101 covers:

• 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!

Who should attend?

This course 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.

Beth Allgaier

Senior Vice President, Business Development and Industry Relations

Beth's Full Bio

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

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

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, 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

Deputy General Counsel

Carolyn's Full Bio

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 D. Howard Ph.D., CAE

Vice President, Regulatory & Scientific Affairs

Marcia's Full Bio

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

Ph.D., 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

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

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.

Duffy MacKay

Senior Vice President, Dietary Supplements

Duffy's Full Bio

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.

Fred Meadows

Senior Director, Regulatory & Scientific Affairs, CHPA

Fred holds a Ph.D. in Analytical Chemistry from Georgia State University.  He has 25 years of experience in product research and development and supporting manufacturing within different industries including pharmaceuticals, medical devices, combination devices, specialty chemicals and agriculture.  Most recently, he worked with the Global Health and Manufacturing Services division at USP, where he led teams that supported pharmaceutical manufacturers in low- and middle-income countries across Asia and Africa. His work focused on technology transfer, product development, GMP compliance, training, and other initiatives to enhance quality and safety, helping these manufacturers secure marketing authorization from regulatory bodies, including the US FDA and the World Health Organization.

Scott Melville

President and CEO

Scott's Full Bio

Scott Melville is the president and chief executive officer of CHPA and leads the organization’s efforts to empower consumer self-care by preserving and expanding choice and availability of consumer healthcare products, including OTC medicines, dietary supplements and consumer medical devices.

Prior to joining CHPA, Melville served as senior vice president of government affairs and general counsel for the Healthcare Distribution Alliance (formerly HDMA), representing pharmaceutical wholesale distributors.

Melville previously served in various public affairs and legal roles for the pharmaceutical and biotechnology companies Sterling-Winthrop, Hoffmann-LaRoche, and Cephalon. Melville began his professional career as a legislative assistant and appropriations committee associate on the staff of retired U.S. Congressman Jerry Lewis (R-Calif.).

He earned his bachelor’s degree in economics and political science from Bucknell University, and his juris doctorate from George Mason University’s Antonin Scalia School of Law. He serves on the boards of the Global Self-Care Federation, and the Health in Hand Foundation.

Caitlin Ondracek, Ph.D.

Senior Director, Regulatory & Scientific Affairs, CHPA

Caitlin Ondracek is a versatile biomedical scientist and non-profit leader with expertise spanning molecular biology, microbiology, immunology, aging, and infectious diseases. Her contributions include novel aging research and a nationally recognized COVID-19 immunity study. In addition to her research, Caitlin has taught at MIT and led numerous scientific initiatives in the non-profit sector. She has extensive experience supporting scientific committees and working groups, fostering collaboration to advance organizational objectives. Her leadership on major initiatives includes restructuring scientific programs, managing COVID-19 projects in partnership with the CDC, and contributing to policy efforts on laboratory-developed tests and FDA regulation. A proven program manager, Caitlin leverages her leadership and organizational skills to drive initiatives that advance evidence-based science and improve public health.

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."

Jay Sirois Ph.D.

Vice President, Regulatory & Scientific Affairs

Jay's Full Bio

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

Senior Vice President, Communications & Public Affairs

Mike's Full Bio

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.

How to Register 

• Member fee:  $995
• Government fee: $325 (this rate is only for government agencies).

Register online. Phone registrations are NOT accepted.

Register 

• A my.chpa.org login and password are required to register online
• New to CHPA? You must create a my.chpa.org profile before registering

Cancellation Policy

Cancellations received by March 7, 2025, will receive a full refund. 
Cancellations received after March 7, 2025, will result in the forfeiture of the entire registration fee. Substitutions are always accepted.

Hotel Information

CHPA does not have a contracted room block but, 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:

• Hotel St. Regis-Washington-DC
• The Hyatt Place Washington DC
• Hilton Garden Inn Washington DC Downtown
• Sofitel Washington DC Lafayette Square