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Consumer Healthcare 101

On Demand

Overview

 

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 on-demand course will cover:

  • The State of the Industry: Commercial Update 2021
  • 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 now available on demand and is open to all CHPA members. Non-members and government employees are also welcome to participate. Please email Ushma J. Suvarnakar for registration rates and information. 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.

Program and Agenda

On Demand Schedule

On Demand

On Demand

Event
Welcome and Overview

The State of the Industry: Commercial Update 2021

IRI will outline the sales size, key brands, manufacturers & marketers, retailers, consumer behavior and key trends for the industry in 2021.  OTCs as well as supplements will be covered.

Speakers:

Lisa Buono, Healthcare & Client Insights Principal, IRI

Katie McNichol, Principal, IRI

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 our products.

Speaker:

Doug Bierer, President, Douglas Bierer Consulting

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.

Speakers:

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

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

OTC Monograph Reform Update

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.

Speakers:

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

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.

Speaker:

Ed Hemwall, Principal, Edwin Hemwall LLC

Medical Devices

Medical devices are an important part of the self-care continuum, especially today when items like digital thermometers, surgical masks, and latex gloves play a critical role in the public’s safety.  As part of CHPA’s new Consumer Healthcare 101 course, viewers will receive an overview of the regulatory framework for medical devices.  Learn about the agency with primary oversight responsibilities for these products, key laws and regulations governing medical devices, and how they are classified.  The session will include references that can assist companies as they explore or expand their interest in this product category.

Speaker:

Evan Phelps, Partner, Amin Talati Wasserman

Advertising 101

Overview of Advertising law governing consumer health products.

Speaker:

Raqiyyah Pippins, Counsel, Arnold & Porter

Cosmetics & Dietary Supplements

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

Speaker:

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

Manufacturing Quality Products

Regulatory requirements that assure quality of OTC medicines, including manufacturing, product testing, expiration dating, etc. and training requirements for employees working in self-care/OTC medicines industries.

Speaker:

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

Our Expert Speakers

 
  • Jennifer Ahearn, Director of Regulatory and Compliance, Engineering Systems, Inc.
  • Doug Bierer, Ph.D., President, Douglas Bierer Consulting, LLC
  • Lisa Buono, Healthcare & Client Insights Principal, IRI
  • Edwin Hemwall, Ph.D., Principal, Edwin Hemwall LLC
  • Marcia D. Howard, Ph.D., Vice President, Regulatory & Scientific Affairs, CHPA
  • Katie McNichol, Principal, IRI
  • Evan Phelps, Partner, Amin Talati Wasserman
  • Raqiyyah Pippins, Esq., Counsel, Arnold & Porter
  • Jay Sirois, Ph.D., Vice President, Regulatory & Scientific Affairs, CHPA

Registration

How to Register for the Virtual Conference

  • Member Registration Virtual - $450
  • Non Member Registration Virtual - $995

Register online. Phone registrations are NOT accepted.

Online registration

Registration & Logistics Questions