Wisconsin Chapter Webcast: Device Requirements for Drug-Led Combination Products

1.0
RAC Credits
Wednesday, 23 June 2021 (12:00 PM) - Wednesday, 23 June 2021 (1:00 PM) Central Time (US & Canada)

Member: $10
Nonmember: $25

Description

With advances in technology, more therapeutic and diagnostic products are combining drugs, devices, and biologics. 

This webcast will cover U.S. FDA requirements applicable to sponsors of drug-led drug/device combination products, including device requirements for the quality management system and good manufacturing practices (GMPs), device content to include in a new drug application (NDA), registration and listing, and post market reporting. 

Attendees will gain a broad understanding of integrating device requirements into plans for development, NDA submission, and post market compliance.

A live Q&A portion with the speaker will follow the presentation.

Learning Level: Intermediate/Advanced 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

This event is brought to you by the RAPS Wisconsin Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Adrienne R. Lenz, senior medical device regulation expert, Hyman, Phelps & McNamara, P.C.

Thank you to our Platinum Chapter Sponsors: