Consumer Healthcare 101
In-person dates: April 9-10, 2024
Additional information coming soon!
CH101 Virtual Course
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 virtual course will cover:
- The State of the Industry: Commercial Update 2022
- FDA Oversight of Nonprescription Drug Products
- OTC Drug Labeling Regulations
- OTC Monograph Reform Update
- Rx-to-OTC Switch
- Advertising 101
- Medical Devices
- Cosmetics & Dietary Supplements
- Manufacturing Quality Products
Inside CH101
Who should attend?
This course is available virtually and 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.
2023 Program
Welcome & Overview
Speaker
Allegra Bartscherer, Director of Member Engagement and Marketing, CHPA
The State of the Industry: Commercial Update 2022
The Circana presentation will outline the sales size, key brands, manufacturers & marketers, retailers, consumer behavior, and key trends for the industry in 2022. OTCs, medical devices, as well as supplements, will be covered.
Speaker
Jackie Caramagna, Client Insights Consultant, Circana
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
Doreen Frank, President, Envigage Consulting, LLC.
FDA Oversight of Nonprescription Drug Products
A discussion of FDA as the industry's leading regulator will include an overview of FDA's structure and the regulatory framework for OTC drug products.
Speaker
Doug Bierer, President, Douglas Bierer Consulting
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
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
Ed Hemwall, Principal, Edwin Hemwall LLC
Marcia Howard, Vice President, Regulatory & Scientific Affairs, CHPA
Advertising 101
Overview or regulatory standards governing consumer health product advertising, including new guidance issued by the Federal Trade Commission regarding claim substantiation, social media, and use of influencers.
Speaker
Raqiyyah Pippins, Partner, Arnold & Porter
Medical Devices
An overview of FDA regulations and guidance related to safety, effectiveness, manufacturing, and claims applicable to medical devices.
Speaker
Marcia Howard, Vice President, Regulatory & Scientific Affairs, CHPA
Christina Kuhn, Associate, Covington
Cosmetics & Dietary Supplements
An overview of the FDA regulations related to safety, labeling, manufacturing and claims for cosmetics and dietary supplements.
Speakers
Larisa Pavlick, Senior Director, Regulatory & Scientific Affairs, CHPA
Jay Sirois, Vice President, Regulatory & Scientific Affairs, CHPA
Manufacturing & Product Quality
A review of the top five deficiencies identified during regulatory inspections and some of the learnings from FDA regulatory action related to OTC medicines and dietary supplement quality.
Learning from regulatory patterns and inspiring continuous improvement for quality systems.
Speakers
Jen Ahearn, Director of Regulatory and Compliance, Engineering Systems Inc.
Larisa Pavlick, Senior Director, Regulatory & Scientific Affairs, CHPA
Our Expert Speakers
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.
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.
Jackie Caramagna is a consumer research and analytics leader with more than 18 years of experience building trusted partnerships through strategic client engagements with leading healthcare and CPG companies. After an early-career role in market research focused on sales forecasting, concept evaluation and brand optimization work for companies such as Mars, Pfizer, RB and Church & Dwight, she joined IRI in 2011 as a Client Insights Consultant in the frozen food category. Since transitioning to Circana’s Healthcare Practice in 2014, Jackie has contributed to several leadership presentations for CHPA and CRN and has become a recognized thought leader who regularly provides Circana perspectives on healthcare industry topics. In her current role, Jackie supports Haleon’s Oral Care portfolio, partnering with the company’s marketing, insights and category management leaders to improve business outcomes and drive brand stability and growth.
Edwin (Ed) Hemwall, Ph.D. brings over 35 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.
Doreen Frank is president of Envisage Consulting, a regulatory consulting firm that provides comprehensive regulatory consulting services to clients in the OTC drug and cosmetic industry. She has over 30 years of regulatory experience in the pharmaceutical industry. At Envisage Consulting, Doreen assists clients with OTC drug development, OTC monograph requirements, labeling, advertising, and promotion across all therapeutic categories. She provides regulatory strategy for Rx-to-OTC switch programs, 505(b)(2) NDA submissions, and OTC monograph drug products. Doreen also provides due diligence reviews for companies engaging in mergers and acquisitions, as well as regulatory assessments for business development and licensing opportunities. Doreen serves on numerous CHPA task groups. She also served for many years on the Executive Committee of the NY/NJ Regulatory Affairs Professional Society (RAPS) Chapter. Doreen is an associate member of CHPA, the Personal Care Products Council, and the Independent Beauty Association. She received her B.S. in biochemistry from Rutgers University and an MBA from Fairleigh Dickinson University.
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.
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 analysing 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.
Larisa Pavlick serves as the leader on quality, technical and manufacturing issues and leads the Product Quality & Manufacturing Controls Committee. She joined CHPA in June 2022 as Senior Director of Quality Assurance and Technical Affairs. She joins with over 25 years of combined industry experience where she specialized in product development, quality, regulatory, and successfully held various positions in operations including as a senior buyer. Her background includes 12 years in the dietary supplement industry and six years working for a trade association, plus nearly eight years at United States Food and Drug Administration (FDA).
Ms. Pippins co-leads the firm’s Consumer Products Practice Group and the Consumer Products & Retail Industry Team. She represents companies engaged in the development, marketing, import, and export of consumer products, including FDA-regulated consumer products, apparel, appliances, and devices. Ms. Pippins focuses her practice on the 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 products. She partners with litigation teams to defend clients against litigation demands alleging unfair and deceptive advertising practices. She also represents companies in advertising challenges before the 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.
Ms. Pippins assists companies with developing promotional strategies relating to federal and state regulations governing direct-to-consumer product promotion. Her experience includes advising on relevant federal and state laws and regulations governing health-related, performance, and sourcing claims; assisting FDA-regulated companies with product development, monograph compliance, and Rx-to-OTC switches; and counseling on the development of clinical and sensory studies intended to substantiate advertising claims. She advises trade organizations supporting manufacturers of FDA-regulated products regarding FTC and state standards that affect a company’s product portfolio risk profile and is regularly invited to work with clients' marketing and research and development teams to identify marketing strategies that are consistent with their desired risk threshold. 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 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.
Registration
How to Register
- Member Registration - $450
- Nonmember Registration - $995
Register online. Phone registrations are NOT accepted.
- 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
Registered attendees have 65 days from the transaction date to complete this course. CHPA will fully refund program registration fees in full of the notification submitted to CHPA via e-mail at meetings@chpa.org. All registration cancellations and refund requests must be made in writing prior to starting any online course. Refunds cannot be approved for started courses, no-shows, or expired online courses. Substitutions are gladly accepted prior to the start of any online course.
Registration Questions