RAPS Foundation

Help shape the future of the regulatory affairs profession

Regulatory Affairs Professionals

This program addresses the complexities companies face when introducing a Medical Device or IVD product onto the Japanese market. This program gives professionals a roadmap with related knowledge and real-life examples of what is required for regulatory clearance including: Quality Management System (QMS) and preapproval audits, JIS standards, Shonin and Summary Technical Document (STED) requirements, Third Party Review bodies, Marketing Authorization Holders (MAHs) and various clinical aspects. This program benefits professionals working in small to mid-size companies that are currently introducing or anticipate introducing a Medical Device or IVD product onto Japan’s market. Presenters address key challenges and provide useful advice for overcoming hurdles throughout the regulatory introduction and clearance process. This program includes lectures, a panel discussion and question and answer forums.

Regulatory affairs professionals play pivotal roles in the development, approval and surveillance of safe and effective health products worldwide, ensuring compliance with applicable laws and regulations.

The profession (al) is a vital bridge between innovators, healthcare providers, consumers and others so that science, medical needs, ethical considerations and the public’s interests are addressed. Regulatory affairs professionals guide health-enhancing products through the regulatory journey by providing the knowledge and understanding to protect public health, reduce suffering and preserve human potential.

Addressing pivotal regulatory issues necessitates careful research, innovative actions and collaboration. These are, in fact, the core elements of the RAPS Foundation.

Foundation Mission

The RAPS Foundation supports research on the profession and the health sector as well as special projects to help support the profession and its evolution worldwide. The RAPS Foundation is funded by contributions and grants from individuals, corporations and other organizations.

Foundation Elements

Examine how the regulatory process can adapt to changing science and transition to a proactive, integral, strategic and value-added process in the health product development lifecycle.
Create new avenues for dialogue among regulatory leaders worldwide to ultimately increase global access to cutting-edge therapies and reduce overlapping requirements or conflicting systems.
Facilitate and support the evolution of the regulatory affairs profession in industry and governments worldwide.
Study the strategic role of the regulatory profession throughout the health product lifecycle and its vital contributions to providing access to safe and effective health products.

Foundation Giving

The RAPS Foundation is a tax-exempt organization under Section 501(c) (3) of the US Internal Revenue Code. Contributions and gifts to the RAPS Foundation are eligible for deduction as a charitable contribution.

Contributions enable the Foundation to fulfill its mission to anticipate and respond to change and address the inevitable challenges and transforming them into opportunities. Your support of the RAPS Foundation helps to create a dynamic future for the RA profession (al) and ultimately a positive contribution to bringing safe and effective healthcare products the marketplace worldwide.

Give today to help advance the regulatory affairs profession. Your contributions – large or small – go a long way in helping RAPS to achieve its mission to provide continual knowledge and advancement and communication to regulatory affairs professionals worldwide.

If you, or your organization, are interested in learning more about RAPS Foundation, please email us at Foundation@raps.org