Disruptive Medicine Innovation: Next Generation of Combination Product Technologies

Register

Date: 09/29/25
Time: 2:00-3:00 PM ET

* Please Note: registration closes at 11:59 PM ET the day before the live event. No further registrations will be accepted once registration has been closed *

Live closed captions are available.

Overview: Combination products are emerging as innovative medical products for patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of a combination product will require collaboration within the industry to overcome regulatory, clinical, and technical challenges. New tools are being developed to assess the safety, efficacy, quality, and performance of combination products, such as computational modeling and simulation, novel technologies such as artificial intelligence, developing new standards, evidence-based research methods, and new approaches including the designation of innovative or breakthrough medical products. Taken together, the fast development of combination products and their great potential in health care provides new opportunities for the advancement of regulatory review as well as life sciences.

Learning Objectives: 

  • Analyze the latest regulatory expectations and challenges
  • Understand potential future innovation platforms
  • Learn about potential and future global convergence and harmonization initiatives for combination products

Speaker Information:

James Wabby, Head, Global Regulatory Affairs - Emerging Technologies and Combination Products, AbbVie

Courtney Evans, Principal Consultant, Suttons Creek

Moderator Information:

Mara Smith-Kouba, Counsel, Regulatory Law, Bristol-Myers Squibb


Continuing Education:

CLE: IMPORTANT CHANGE REGARDING CLE CREDIT: We are now working with ABA CLE for our accreditation needs. To earn credits during a live webinar, attendees must be logged into the webinar for at least 75 minutes (of a 90-minute webinar) or 55 minutes (of a 60-minute webinar). Then, they will receive a personalized CLE affidavit from mcle-ahla@americanbar.org. Watch for this email within 7-10 business days. If you do not receive it, please check your spam or junk folders as these emails often end up there. Please note you will fill out one affidavit for the full event. Once you complete the affidavit, you will be able to download your certificate(s) of attendance, and certificates will be emailed to you from mcle-ahla@americanbar.org.

CPE: AHLA is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Nashville, TN 37219-2417. Website: www.nasba.org. For further information, please visit our Continuing Education Page.

AHLA is seeking CPE credits for live webinars. The maximum number of credits available is 1.80.


Register