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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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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Labeling process optimization requires a high-level framework for managing the key aspects of a technology-appropriate and scalable, end-to-end process. This broadcast will review the best methods to evaluate factors that could affect product labeling management. You will learn the steps involved to efficiently track, align and communicate label content both internally and for successful registration and submissions. The webcast will also cover the complex roles globalization, compliance, harmonization, quality and translations all play in this process.
Agenda:
Learning Level:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Learning Objectives:
Who Should Attend:
Speakers:
Cham Williams, Regulatory Business Process and Technology, IQVIA
Cham Williams has more than 20 years experience in the Life Science industry working globally for pharmaceutical, consulting and technology solution companies. Now at IQVIA, Cham is bridging the technology and business worlds to help design products that help shape the next generation of RIM solutions. His expertise includes managing regulatory technology, business process optimization and systems planning and implementation. Prior to IQVIA, Cham was a principal consultant advising clients on regulatory strategy and process development. He started his career at GSK where he was part of a pioneering submissions team recognized for submitting electronic CRFs, which later led to the development of electronic NDAs.
Cham holds a BS in Economics from the University of the West Indies and a MS in Project Management from Drexel University. He has been published in the International Journal of Global Business.
Peter Muller, Sales Director North America, Schlafender Hase
For the last 20 years, Peter Muller has worked on software and process improvement projects relating to proofreading with Fortune 500 companies in the pharmaceutical, medical device, and consumer goods industries. He has a wealth of experience working with international clients to define their organization's goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.