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3 events found

City: Bogota  or Athens  or Tarragona  or Berlin  or Oeiras  or Ljubljana 

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Keywords: ISO 13485  or CE Marking  or Evolution 

  • AET16 Applied Evolutionary Theory

    7 - 11 November 2016

    Oeiras, Portugal

    AET16 Applied Evolutionary Theory https://tess.elixir-europe.org/events/aet16-applied-evolutionary-theory For many of its history, our knowledge of evolution has been based heavily on theoretical models and hypotheses. In the age of novel experimental and technological approaches, we are now increasingly able to evaluate this theory; however, the basics of how and why to develop and analyze a simple model are often forgotten in the process of NGS analysis. This course aims at training evolutionary biologists in classical modeling and teach them ways to approach their own research questions through evolutionary theory. Primarily through interactive hands-on sessions, complemented by an introduction to the cornerstones of modeling and its application to data analysis, this course will familiarize the participants with ways of approaching a research question with a simple model, and different strategies at gaining insight from the model. In groups of two, course participants will develop and analyze their own toy model in the course and present their findings to the group on the last day. Topics that will be covered in the course include the following: Why and how are models useful? How to write down/develop a model How simple/complicated should a model be? Which modeling approach/programming language should I use for my question? How to nail down a question with a model Extracting results from an equation/simulation How to evaluate a model using empirical data Participants can use their preferred programming language during the hands-on sessions, and free access to Wolfram Mathematica will be provided. The instructors have modeling experience using Mathematica, R, Python, and C++. 2016-11-07 09:00:00 UTC 2016-11-11 00:00:00 UTC Instituto Gulbenkian de Ciência Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal 901 Computational biology Evolutionary biology [] [] [] workshops_and_courses [] Evolutionmodelling
  • Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications

    12 - 13 October 2017

    Berlin, Germany

    Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications https://tess.elixir-europe.org/events/medical-devices-eu-directives-guidance-ce-marking-and-iso-standard-certifications Things are changing for Medical Devices and IVDs in the European Union (EU): new fundamental standards, new EU device regulations and BREXIT. What is now needed to enter or, more importantly, to maintain presence in this attractive marketplace for medical devices? Satisfying requirements harmonized across the 28 member states should be a straightforward process to get products approved for distribution in each country - but is it? This course identifies and explains the requirements – old and new – for medical devices, the steps to obtain entry into the marketplace (including setting up on-going procedures and relationships), the increasing importance of Clinical Evaluation and Post Market surveillance, Notified Bodies and Competent Authorities. The course also shares some lessons learned from the Course Director, who has over 25 years of experience with CE marking medical devices for distribution in the EU. 2017-10-12 09:00:00 UTC 2017-10-13 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 Medical Device 20 workshops_and_courses first_come_first_served EU DirectivesGuidanceCE MarkingISO Standard
  • Medical Device Validation Training for Professionals

    18 - 20 October 2017

    Berlin, Germany

    Medical Device Validation Training for Professionals https://tess.elixir-europe.org/events/medical-device-validation-training-for-professionals-59a3279d-a054-43b1-af46-f7d93e708dc7 Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products. Issues to be covered include: •Learn how poor validation procedures and practices can lead to regulatory actions from regulators •Assurance of product quality derived from a compliant validation program •Learn how to improve process system knowledge and understanding •Learn methods for developing process validations and best practices •Understand the scope of regulations governing process validation and identify gaps •Develop a plan to rectify existing validation plans, protocols and reports •Learn how to implement and deploy a master validation plan Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course. 2017-10-18 09:00:00 UTC 2017-10-20 15:00:00 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 Regulatory AffairsQuality Assurance & ControlProcess DevelopmentAuditing & Compliance Engineering 20 workshops_and_courses first_come_first_served Process Validationproduct safetyMedical DeviceCFR 820ISO 13485
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