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RF Series

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Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Breakthrough Therapy Designation/Accelerated Approval/EMAs PRIME

This session will review case studies, breakdown the background of BTD and tackle the pros and cons of EMA PRIME.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Bringing Medical Devices to Market for Small Patient Populations: A Practical Perspective for Pediatrics and Rare Diseases

The pediatric market is far smaller than the market for adults, which makes it difficult for companies to recoup research and development costs to develop pediatric devices.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: CDRH Strategic Update: Initiatives/Priorities

Join us as FDA introduces its 2016-17 priorities and initiatives.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Closing Keynote Address: The Patient Perspective on Chronically Happy Living

In this powerful and entertaining closing keynote, Hartwell shares the lessons she has learned along her journey and how the healthcare community helped her live the life she was meant to live.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Efficient Registration of Medical Products through APEC Good Registration Management (GRM)

GRM is a concept to promote efficient registration of medical products by promoting good review practices and good submission practices cooperatively between regulatory authorities and applicants.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: EU Medical Device Regulation and In Vitro Diagnostic Regulations

Get insight on best practices for the implementation and prioritization of the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR).
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: ISO 13485:2016

Get practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Morning Panel Discussion: Innovation and Technology: Practical Applications for Regulatory

Experts discuss continuous monitoring, data privacy and security, and disease management within a case study ecosystem including how various aspects should be regulated.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Open Keynote Address: Innovation and Technology: How Does Regulatory Keep Up

Healthcare, as we know it, is being disrupted by innovation and technology. Don't get left behind. Buckle up for a rapidly changing healthcare landscape with emerging technologies, new business models and new regulatory challenges.
2016 RAPS Regulatory Convergence
Session Recording
Member Free
Non-Member N/A

2016 RAPS Regulatory Convergence: Real-World Evidence: Registry, Observational and Clinical Studies

In order to develop a thorough story of safety, effectiveness and quality for your product's performance, it is essential to gather real-world evidence. How do you do that?
2016 RAPS Regulatory Convergence