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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.
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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 Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
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With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
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Narratives are an integral part of medical writing. Sponsors sometimes need to prepare large batches of these deliverables in a short period while most traditional methods prove unsuccessful in providing both consistency and quality. This can lead to questions and potential discrepancies in the reporting of a drug’s safety. Fortunately, through the advancement and use of technology and other streamlined writing approaches, there are options to deliver high quality narratives on time. In this presentation, you will gain a new perspective on the future of patient narrative production. You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
Our resident narrative and transparency and disclosure experts will provide the tools and tips needed to ensure quality, consistency, efficiency, and cost-savings imperative to the narrative generation process. We will identify the past and current health authority review process, discuss how to work through complicated or dense data to produce a streamlined narrative for submission, and highlight efficiencies gained through the application of technology into the narrative process.
Audience 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
Who Should Attend
Speakers
Gabriella Mangino, Product Manager, Synchrogenix Information Strategies, Inc., a Certara company
Beth Miller has more than 15 years of regulatory and safety writing and project management experience in the pharmaceutical industry. Specialties include writing, editing, and managing safety narrative projects and other regulatory documents. As a Safety Project Manager at Synchrogenix, Dr. Miller is responsible for all aspects of project management for safety and narrative projects, including the development of strategies for organizing and preparing narratives and safety deliverables.