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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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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