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City: Bogota  or Copenhagen  or Berlin  or Liverpool  or Philadelphia 

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Keywords: Regulatory  or new product plan  

  • Introduction to Effective Medical Writing

    25 - 26 September 2017

    Berlin, Germany

    Introduction to Effective Medical Writing https://tess.elixir-europe.org/events/introduction-to-effective-medical-writing Medical writing is both a science and an art. The art of medical writing is to comprehend and present scientific information clearly to suit the specific target audience's level of understanding including patients, the general public, physicians and/or regulatory agencies. Often it is not poor science that kills a scientific paper; rather, it is the lack of clarity and continuity. Poor writing can be very costly to companies and frequently slows the review process of regulatory submissions. In this 2-day course, you will learn about the different types of medical writing and how to write effectively. We will examine various types of writing including abstracts, regulatory documents, and patient education materials. We will also consider ethical issues that face medical writers. You will gain insight into the design of effective documents and what goes into putting together a compelling manuscript. You will also learn how to keep your writing free of medical jargon and common grammatical errors, while ensuring the scientific integrity of your work. 2017-09-25 09:00:00 UTC 2017-09-26 05:00:00 UTC The Center for Professional Innovation & Education Mohrenstraße 30, 30, Mohrenstraße, Berlin, Germany Mohrenstraße 30, 30, Mohrenstraße Berlin Germany The Center for Professional Innovation & Education info@cfpie.com The Center for Professional Innovation & Education PharmaceuticalMedical Device 20 workshops_and_courses first_come_first_served Medical WritingRegulatorySubmissions
  • European Union Regulatory Issues - New Product Development

    16 - 17 October 2017

    Berlin, Germany

    European Union Regulatory Issues - New Product Development https://tess.elixir-europe.org/events/european-union-regulatory-issues-new-product-development This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU. The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided. The course will provide the attendee with a thorough knowledge of the following topics: •How to develop a regulatory strategy •How to deal with pricing and reimbursement issues in your development •How to validate your regulatory strategy (scientific advice) and how to choose between centralized and national scientific advice •When does your product qualify as an orphan medicinal product and what are the advantages if it does? •How to deal with pediatric development plans •What has to be considered for Advanced Therapy Medicinal Product and oncology medicinal products 2017-10-16 09:00:00 UTC 2017-10-17 17:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany [] info@cfpie.com The Center for Professional Innovation & Education PharmaceuticalMedical DeviceBiotech 20 [] first_come_first_served regulatory strategyEuropean Union Regulatory Issues new product plan
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