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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.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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Is your organization facing hurdles regarding MDR certification? What about recertification under MDD? Join RAPS and Celegence for a webcast where regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.
During the discussion panel, you will have the opportunity to ask questions and develop a comprehensive and advanced understanding of potential strategic solutions for MDR compliance, regardless of where you are in the transition process. You will also learn how to take advantage of the extension for both MDD renewal and MDR implementation.
Join us and get your questions on MDR certification and recertification under MDD answered by Celegence experts.
Agenda
* RAPS and Celegence invite you to stick around at the conclusion of the live webcast for a 30-minute bonus session with our sponsor! It's a new type of programming we're trying out as part of RAPS' ongoing efforts to help connect regulatory professionals to vendors who serve the regulatory profession*
Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity
Learning Objectives
Upon conclusion of the program, you will:
Who Should Attend
Speakers
Ramesh Annayappa, associate director (medical device services), Celegence
Sophie Vaillot, global head of regulatory affairs, Nobel Biocare
Dr. Royth von Hahn, senior vice president medical & health services, TÜV SÜD Product Service Division