1. What is RAPS ?
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.
2. What is RAPS Switzerland Chapter?
The RAPS Switzerland Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships and increase knowledge, competence and performance. RAPS is a volunteer-driven organization, and we’ve found that the more we put into it, the more we get back. There are a number of volunteer opportunities available at the chapter and national levels, and we are happy to help you identify something that meets your interests and serves your personal growth needs.
The Switzerland Chapter of RAPS is a legal association in Swizerland. The association pursues the following goal: to develop and maintain a competent professional framework in international regulatory affairs and stimulating good practices and regulatory policies to advance public health through: the organization of education and engagement opportunities local and accessible; the representation in Switzerland of RAPS by being in direct contact with individual members, clients and other interested parties wherever they live and work; identifying local and regional needs and sharing this information with the RAPS network; contributing to RAPS's annual planning process, enabling it to develop local, national and international solutions for the profession; creating an entry point for strategic relationships with industry partners, agencies and organizations.
3. What is Regulatory Affairs?
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, specifically pharmaceuticals, medical devices, and diagnostics products within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals
Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:
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Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
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Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals) and Notified bodies (medical devices).
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Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs.
4. How to become a member?
The RAPS Switzerland Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships and increase knowledge, competence and performance. RAPS is a volunteer-driven organization, and we’ve found that the more we put into it, the more we get back. There are a number of volunteer opportunities available at the chapter and national levels, and we are happy to help you identify something that meets your interests and serves your personal growth needs.