RAPS Workshop: Navigating Regulatory Challenges for Complex Devices, cATMPs, and Combination Products Delivery

Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.

With the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Combination products are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used in treatments. However, the combination products that are some of the most innovative are regenerative medicine products. These types of products can provide cures for previously untreatable conditions, which can truly change the face of the industry.

In this webinar, you will learn through case studies and a panel discussion how to navigate the future regulatory framework for unmet medical needs and next generation of drug delivery devices. Discover how it will lead to the industry developing emerging and disruptive combination products for use within the umbrella of precision medicine. Technology innovations driving precision medicine include community-wide genetic screening and early disease detection and risk management, preventative health strategies, digital health strategies, wellness programs will also be discussed.

Learning Objectives:

Upon completion of this workshop, participants will be able to:

Analyze the latest regulatory expectations and challenges.
Understand potential future innovation platforms.
Comprehend potential and future Global Convergence/Harmonization initiatives for combination products and understand the regulatory challenges and opportunities ahead.

Audience Learning Level

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.

Who Should Attend

Mid-senior level quality assurance and regulatory affairs professionals who are involved with the development and commercialization of complex devices and combination products.

Research and development specialists
QA managers
Global Regulatory Strategy Leads

Agenda

Time	Topic
10:00 AM	Overview of Integrated Regulatory Strategy: Phase-specific Risk Management and Quality Systems Strategic Cross-functional Collaboration Analysis of Market Dynamics and Jurisdictional Considerations
10:45 AM	Interactive Workshop: Strategic Partnership Development and CDMO Engagement
11:30 AM	Break
11:40 AM	Deep Dive: Leveraging Target Product Profiles (TPPs) to Enhance Regulatory Pathways for Complex Devices and Combination Products
11:55 AM	Hands-on Workshop: Optimal Integration and Utilization of TPPs for Device Development
12:40 PM	Consolidation and Discussion of Key Insights
1:00 PM	Course Adjourned

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.