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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.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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PharmaLex utilizes the strength and breadth of it multidisciplinary team, as well as its extensive global network, to help clients navigate the regulatory landscape. We specialize in development consulting & scientific affairs, regulatory affairs and pharmacovigilance, offering customized and individually adapted solutions. We manage large-scale outsourcing projects as well as providing strategic project support for specialist indications that require expert knowledge. We collaborate with you to advocate for your company, your ideas, and your products.
PharmaLex GmbH Harrlachweg 6 68163 Mannheim Germany Phone: +49 621 18 15 38 0 Email: contact@pharmalex.com
Eva Keck Director Marketing Social Media Links: LinkedIn: https://www.linkedin.com/company/pharmalex-gmbh Xing: https://www.xing.com/companies/pharmalexgmbh Twitter: https://twitter.com/PharmaLexUS
• Environmental risk assessment
Pharmacovigilance • Risk management • Signal management • Periodic safety reports • Pharmacovigilance system and compliance • EU-QPPV / local QPPV • Quality system, audit and inspection support • Safety data exchange agreements • ICSR management, including collection, evaluation, processing, distribution and reporting