Defining the Primary Mode of Action as a Drug or Device to Determine FDA Jurisdiction, Ensuring Optimized Human Factors Study Design to Prove Safe Patient Use, while Maintaining Compliance With Post Market Reporting Requirements
In the past decade, development of medical products encompassing both a drug and device component has rapidly increased and provided impactful life-improving results to patients, placing the overall combination product market at the forefront of the industry’s interest. As such, the overall regulatory landscape has yet to clearly address distinct drug-device product specificities and currently includes many grey areas. Executives working in the combination products industry focus on navigating multiple regulatory pathways including complex submissions for approval, as well as maintaining awareness of the ever changing regulatory landscape both within the USA and globally. With the primary challenge of determining whether the product will ultimately be qualified, and thus regulated as a drug or device by the FDA, it is of the utmost importance to obtain a clear understanding of each jurisdiction’s submission requirements and process in order to secure streamlined and expedited approval. Professionals must also decipher best methods for usability and human factors testing to ensure diverse patient population needs are considered in study design, labeling is coordinated correctly and safe use of the product in the real-world setting is guaranteed. In addition, new guidance on post market reporting requires regulatory experts to enhance collaboration with quality executives for continued compliance and optimized reporting practices.
Regulatory executives must also understand requirements in the changing global landscape, such as the implementation and effects of EU MDR on combination products, as well as new industry innovations including the use of software and patient apps in conjunction with drug therapies. With a variety in session formats, such as small group discussions for peer to peer sharing, panels featuring diverse perspectives, and case studies showcasing industry best practices, this meeting will provide an unrivaled opportunity for combination product teams to share experience and intelligence in overcoming pressing concerns and challenges Blending the highest level of insight from both industry veterans as well as regulatory and legal authorities, the Q1 Combination Products Regulation Conference will provide executives with the tools needed to leverage regulatory knowledge impacting strategies and ensuring compliance throughout the organization.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
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