Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-507-L04-P; CME 2.75; IACET 2.75; RN 2.75
Pre-registration required and is an additional fee.
*Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's
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This Short Course will be offered virtually – Join from anywhere! Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus 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. Implementation of a strategy includes the compilation of the plans and/or documents pertaining to strategic partnerships, intellectual property (IP) initiatives, product development approaches, quality management systems (QMS) optimizations, and regulatory submission plans into the integrated regulatory strategy for the complete “asset” as the traditional “ways of working” and/or processes will be challenged when developing an innovative combination product. This short course will explore key challenges and opportunities, offering practical exercises and a structured framework for success. It will focus on mitigating regulatory risk(s) in submissions timeliness and addressing issues such as excessive queries from health authorities, additional testing needs, and delays that impact time to market. Receive
$50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!
Who should attend?Entry/Intermediate professionals in quality, product development, and risk management who are suppliers/CDMOs or patent attorneys.
Learning Objectives- Analyze the latest regulatory expectations and challenges for complex devices and combination products
- Explain potential future innovation platforms
- Identify opportunities to integrate regulatory strategies across functional areas including risk management activities and content between Sponsors, Suppliers and CDMOs
