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Wednesday, June 27 • 8:00am - 9:15am
#314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-633-L04-P; CME 1.25; IACET 1.25; RN 1.25

Combination products in the US are becoming mainstream in the healthcare industry. While there are a number of resources focusing on premarket and post-market requirements for combination products, the requirements for labeling, advertising and promotion are often neglected or under-emphasized.Labeling requirements for combination products (including advertising and promotion) are dictated by the product’s primary designation (i.e. drug, device or biologic). However, there are nuances unique to combination products that companies must consider, especially for companies expanding from a traditional pharma or device platform to combination products. Aside from different requirements, there are also different philosophies in how each industry develops labeling and the development of claims for use in advertising and promotion. Many combination products are intended for “home-use”. Health literacy and human factors are critical to the labeling process for these products. How should manufacturers practically address human factors in its product labeling? What about individually packaged devices intended to be used with an individually packaged drugs; or co-packaged combination products? - what is cross-labeling and how can it be practically managed? Do co-packaging products impact labeling? And, what opportunities the future of devices references drugs and cross-labeling may bring. Case examples will be presented, and a panel of experts share their experiences and answer audience questions. This session will be interactive and audience participation is highly encouraged.

Learning Objectives

Describe the regulatory labeling/AdPromo nuances and challenges specific for different types of combination products; Discuss differences in labeling development and approaches to support promotional claims in the pharma and device industries; Identify how to practically address human factors for “home use” combination products; Describe the components of cross-labeling, and the unique challenges related to implementation.


Kerri-Anne Mallet, MBA


Utilization of Human Factors Studies
Darin Seth Oppenheimer

Cross Labeling and Devices Referencing Drugs
Alexander Varond, JD

Labeling and Ad/Prom Challenges for Combination Products
Anthony Genovese, PharmD

avatar for Anthony Genovese

Anthony Genovese

Deputy Director, Advertising and Promotion, Bayer Healthcare
Anthony is a Deputy Director in the Regulatory Affairs Advertising and Promotion group at Bayer HealthCare. Over the last eight years at Bayer, he has had experience across several therapeutic areas including drug and device delivery systems. Prior to that, Anthony worked in Medical... Read More →
avatar for Kerri-Anne Mallet

Kerri-Anne Mallet

Vice President, Clinical and Regulatory Affairs, Pharmatech Associates, Inc.
Kerri-Anne Mallet is Vice President of Clinical & Regulatory Affairs at Pharmatech Associates and chairs the DIA Devices & Diagnostics Community. She also serves as an advisor for Summit Street Medical, LLC, an early stage drug delivery device. Kerri has been in the biotechnology/medical... Read More →
avatar for Darin Oppenheimer

Darin Oppenheimer

Executive Director, Drug Device Center of Excellence, Merck & Co., Inc.
Dr. Darin Oppenheimer is an Executive Director of the Drug Device Center of Excellence focusing on Medical Devices and Combination products at Merck. After spending 15 years working in Regulatory Affairs and Development for various organizations within the Medical Device and Pharmaceutical... Read More →
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum