Press Release (ePRNews.com) - TORONTO - Oct 19, 2018 - Join Juliane Mills, MPH, MS, Real World Solutions – Scientific Affairs at PRA Health Sciences, for a live webinar upcoming on Thursday, Nov. 8, 2018, at 11 a.m. EST (4 p.m. GMT/UK).
Beginning in 2012 with the Food and Drug Administration Safety and Innovation Act (FDASIA) reauthorization of the Prescription Drug User Fee Act (PDUFA), the FDA has recognized two things: that patients are experts in their disease and that endpoints, symptoms and the impacts of disease that are important to patients do not always align with the clinical endpoints used to support medical product development. This initiative to capture the “patient voice” was further reinforced as a priority for the FDA within Section 3002 of the 21st Century Cures Act, which aims to standardize the collection methods, types of data and analysis of the patient experience.
As part of the 21st Century Cures Act, FDA is obligated to develop guidance(s) on the collection of patient experience data and the use of such data and related information in drug development. This obligation includes defining the methodology for collection and measurement of patient experience data, how such data and related information may be incorporated during product development and presentation of such data for consideration in regulatory decision making, including product submission for approval.
The FDA has stated their intent to satisfy this obligation through public workshops with all Patient-Focused Drug Development (PFDD) stakeholders (e.g., academia, healthcare providers, communities, advocacy groups and drug/device developers) which will culminate in the release of four guidance documents. The first of these guidance documents describing methodological considerations for data collection, reporting, management and analysis of patient experience data was released in draft format in June 2018. Additionally, FDA is also scheduled to hold a public meeting in early October on methods to identify factors of importance to patients.
Within the context of real-world research and the impact of the 21st Century Cures Act on current and future design and implementation strategies, this webinar will explore:
- The history of the 21st Century Cures Act, Section 3002 on incorporating patient experience into drug development and FDA fulfillment of these obligations to date
- Key concepts from the June 2018 draft FDA guidance on Patient-Focused Drug Development (PFDD)
- Preliminary themes from the October public meeting on PFDD methods
For more information about this complimentary webinar, visit How the 21st Century Cures Act and FDA Guidelines for Patient-Focused Drug Development Impact Real-World Research.
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Nima Rajan Source :
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