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180 events found

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  • NDARC16 - NGS Data Analysis, RNAseq, ChIPseq

    29 March - 1 April 2016

    Oeiras, Portugal

    NDARC16 - NGS Data Analysis, RNAseq, ChIPseq https://tess.elixir-europe.org/events/ndarc16-ngs-data-analysis-rnaseq-chipseq 2016-03-29 01:00:00 UTC 2016-04-01 01:00:00 UTC GTPB Oeiras, Portugal Oeiras Portugal Bioinformatics [] [] [] workshops_and_courses [] []
  • PDA16 - Proteomics Data Analysis

    11 - 15 April 2016

    Oeiras, Portugal

    PDA16 - Proteomics Data Analysis https://tess.elixir-europe.org/events/pda16-proteomics-data-analysis 2016-04-11 01:00:00 UTC 2016-04-15 01:00:00 UTC GTPB Oeiras, Portugal Oeiras Portugal Proteomics Bioinformatics [] [] [] workshops_and_courses [] []
  • 2nd Annual International Conference on Nursing

    2 - 5 May 2016

    Athens, Greece

    2nd Annual International Conference on Nursing https://tess.elixir-europe.org/events/2nd-annual-international-conference-on-nursing 2016-05-02 01:00:00 UTC 2016-05-05 01:00:00 UTC Athens, Greece Athens Greece Medicine [] [] [] meetings_and_conferences [] []
  • 4th Annual International Conference on Health & Medical Sciences

    2 - 5 May 2016

    Athens, Greece

    4th Annual International Conference on Health & Medical Sciences https://tess.elixir-europe.org/events/4th-annual-international-conference-on-health-medical-sciences 2016-05-02 01:00:00 UTC 2016-05-05 01:00:00 UTC Athens, Greece Athens Greece Medicine [] [] [] meetings_and_conferences [] []
  • 2nd Annual International Conference on Public Health

    2 - 5 May 2016

    Athens, Greece

    2nd Annual International Conference on Public Health https://tess.elixir-europe.org/events/2nd-annual-international-conference-on-public-health 2016-05-02 01:00:00 UTC 2016-05-05 01:00:00 UTC Athens, Greece Athens Greece [] [] [] meetings_and_conferences [] []
  • 2nd Annual International Conference on Biology

    20 - 23 June 2016

    Athens, Greece

    2nd Annual International Conference on Biology https://tess.elixir-europe.org/events/2nd-annual-international-conference-on-biology 2016-06-20 01:00:00 UTC 2016-06-23 01:00:00 UTC Athens, Greece Athens Greece Systems biology Medicine [] [] [] meetings_and_conferences [] []
  • 3D developmental imaging

    1 - 9 July 2016

    Oeiras, Portugal

    3D developmental imaging https://tess.elixir-europe.org/events/3d-developmental-imaging-ef423a88-07c8-4739-abdc-00a39b15fe20 2016-07-01 01:00:00 UTC 2016-07-09 01:00:00 UTC EMBO Oeiras, Portugal Oeiras Portugal Systems biology [] [] [] workshops_and_courses [] []
  • BPBR16

    11 - 15 July 2016

    Oeiras, Portugal

    BPBR16 https://tess.elixir-europe.org/events/bpbr16 Python is an object-oriented programming language that is ideal for biological data analysis. The course will start from zero knowledge, and will introduce the participants to all the basic concepts of Python such as calculating, organizing data, reading and writing files, program logic and writing larger programs. All the examples and practical sessions will focus on solving biological problems. 2016-07-11 09:00:00 UTC 2016-07-15 00:00:00 UTC Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal Bioinformatics [] [] [] workshops_and_courses [] []
  • PM16 Precision medicine

    27 - 30 September 2016

    Oeiras, Portugal

    PM16 Precision medicine https://tess.elixir-europe.org/events/pm16-precision-medicine The implementation of cancer genomics into the clinic is becoming a reality. Personalized medicine or Precision medicine as other authors refers, uses molecular data of a specific patient to guide clinical decisions such as prevention, diagnosis and treatment. This will revolutionize healthcare and will play a dominant role in the future of cancer therapy. Bioinformatics analyses are essential to identify patients who will benefit from treatment based on their molecular profile, and to tailor chemotherapeutic regimens accordingly. The aim of the course is to present a complete computational pipeline for the analysis and interpretation of Next-Generation Sequencing (NGS) data such as exome sequencing or targeted panels that are commonly used in the clinic. We will address the implementation of large-scale genomic sequencing in clinical practice and the recently developed computational strategies for the analysis of NGS data with a particular emphasis on the interpretation of the results, selection of biomarkers of drug response and afford opportunities to match therapies with the characteristics of the individual patient's tumour. Exercises and case studies focused on cancer will be used to illustrate the principles of how genetics influence led to refining diagnoses and personalized treatment of cancer disease. 2016-09-27 09:00:00 UTC 2016-09-30 00:00:00 UTC Instituto Gulbenkian de Ciência Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal 901 [] [] [] workshops_and_courses [] PersonalizedMedicine
  • NMDPD 2016: Non-Motor Dysfunctions in Parkinson's and Related Disorders

    6 - 9 October 2016

    Ljubljana, Slovenia

    NMDPD 2016: Non-Motor Dysfunctions in Parkinson's and Related Disorders https://tess.elixir-europe.org/events/nmdpd-2016-non-motor-dysfunctions-in-parkinson-s-and-related-disorders 2016-10-06 01:00:00 UTC 2016-10-09 01:00:00 UTC Ljubljana, Slovenia Ljubljana Slovenia Immunology [] [] [] meetings_and_conferences [] []
  • HeCrA-HSCBB16

    7 - 9 October 2016

    Athens, Greece

    HeCrA-HSCBB16 https://tess.elixir-europe.org/events/hecra-hscbb16 The Conference is the major event both of HeCrA & HSCBB. It is a forum to communicate state-of-the-art research, interact and establish scientific networks and collaborations. 2016-10-07 00:00:00 UTC 2016-10-09 00:00:00 UTC Agricultural University of Athens, Athens, Greece Agricultural University of Athens Athens Greece Bioinformatics [] [] [] meetings_and_conferences [] []
  • 3DAROC16

    10 - 14 October 2016

    Oeiras, Portugal

    3DAROC16 https://tess.elixir-europe.org/events/3daroc16 3C-based methods, such as Hi-C, produce a huge amount of raw data as pairs of DNA reads that are in close spatial proximity in the cell nucleus. Overall, those interaction matrices have been used to study how the genome folds within the nucleus, which is one of the most fascinating problems in modern biology. The rigorous analysis of those paired-reads using computational tools has been essential to fully exploit the experimental technique, and to study how the genome is folded in the space. Currently, there is a clear expansion on the wealth of data on genome structure with the availability of many datasets of Hi-C experiments down to 1Kb resolution (see for example: http://hic.umassmed.edu/welcome/welcome.php ; http://promoter.bx.psu.edu/hi-c/view.php or http://www.aidenlab.org/data.html ). In this course, participants will learn to use TADbit, a software designed and developed to manage all dimensionalities of the Hi-C data: 1D - Map paired-end sequences to generate Hi-C interaction matrices 2D - Normalize matrices and identify constitutive domains (TADs, compartments) 3D - Generate populations of structures which satisfy the Hi-C interaction matrices 4D - Compare samples at different time points Participants can bring- specific biological questions and/or their own 3C-based data to analyze during the course. At the end of the course, participants will be familiar with the TADbit software and will be able to fully analyze Hi-C data. Note: Although the TADbit software is central in this course, alternative software will be discussed for each part of the analysis. 2016-10-10 09:00:00 UTC 2016-10-14 00:00:00 UTC Instituto Gulbenkian de Ciência Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal 901 Sequencing [] [] [] workshops_and_courses [] Hi-Cdata
  • 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
  • Train-the-Trainer course

    28 - 30 November 2016

    Ljubljana, Slovenia

    Elixir node event
    Train-the-Trainer course https://tess.elixir-europe.org/events/train-the-trainer-course ELIXIR-EXCELERATE Train-the-Trainer course, Nov 28-30, 2016 at the University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia 2016-11-28 09:00:00 UTC 2016-11-30 17:00:00 UTC ELIXIR Slovenia University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia University of Ljubljana, Faculty of Medicine Ljubljana Slovenia Computer science University of Ljubljana, Faculty of Medicine [] life scientistsResearchersPhD students 20 workshops_and_courses registration_of_interest Computer sciencelife sciencestrainingeLearningEeLP
  • Linux Command line course

    30 November 2016

    Ljubljana, Slovenia

    Elixir node event
    Linux Command line course https://tess.elixir-europe.org/events/linux-command-line-course ELIXIR tutorial "Linux Command line course", Nov 30, 2016 at the University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia 2016-11-30 09:00:00 UTC 2016-11-30 17:00:00 UTC ELIXIR Slovenia University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia University of Ljubljana, Faculty of Medicine Ljubljana Slovenia Computer science University of Ljubljana, Faculty of Medicine [] life scientistsResearchersPhD students 20 workshops_and_courses registration_of_interest Computer sciencelife sciencestrainingeLearningEeLP
  • PDA17 Proteomics Data Analysis

    6 March 2017

    Oeiras, Portugal

    Elixir node event
    PDA17 Proteomics Data Analysis https://tess.elixir-europe.org/events/proteomics-data-analysis    IMPORTANT DATES for this Course   Deadline for applications: Feb 25th 2017 (New)   Course date: March 6th - March 10th 2017 Candidates with adequate profile will be accepted in the next 72 hours after the application until we reach 20 participants. Course description Mass spectrometry based proteomic experiments generate ever larger datasets and, as a consequence, complex data interpretation challenges. In this course, the concepts and methods required to tackle these challenges will be introduced, covering both protein identification and quantification. The core focus will be on shotgun proteomics data. Quantification through isobaric labels (iTRAQ, TMT) and label-free precursor peptide (MS1) ion intensities will also be introduced. The course will rely exclusively on free and user-friendly software, all of which can be directly applied in your lab upon your return from the course. An introduction to available online resources and repositories will also be given. Here you will see how to link the results from proteomic experiments with external data to conduct pathway, gene ontology and interaction analyses. In the course, you will also learn how to submit data to the ProteomeXchange online repositories, and how to browse and reprocess publicly available data from these repositories. The course will provide a solid basis for beginners, but also new perspectives to those already familiar with standard data interpretation procedures in proteomics. Note: this is a highly interactive course. It requires that the participants interact with each other and with the course instructors, in order to reach the learning outcomes in full. Course Pre-requisites The participants should have a basic knowledge about mass spectrometry based proteomics. Experience in analyzing proteomics data is an advantage, but not mandatory. The course does not require advanced computer skills. 2017-03-06 09:30:00 UTC 2017-03-06 09:30:00 UTC Pedro Fernandes Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal 2781-901 Mass spectrometry Proteomics Instituto Gulbenkian de Ciência bicourses@igc.gulbenkian.pt [] [] 20 workshops_and_courses registration_of_interest []
  • PGDH17 Population Genetics and Demographic History: model-based approaches

    13 March 2017

    Oeiras, Portugal

    Elixir node event
    PGDH17 Population Genetics and Demographic History: model-based approaches https://tess.elixir-europe.org/events/pgdh17-population-genetics-and-demographic-history    IMPORTANT DATES for this Course    Deadline for applications: Mar 6th 2017 (New)    Course date: March 13th - March 17th 2017 Candidates with adequate profile will be accepted in the next 72 hours after the application until we reach 20 participants. Course description Genetic and genomic data are increasingly used by ecologists and evolutionary biologists in general. It has thus become important for many biologists with different levels of experience to produce and analyse genetic (and genomic) data. In this course we will take a practical approach to the analysis of genetic and genomic data, but we will also provide some of the theoretical background required to understand the outputs of the software used. This course will be organised so as to mix lectures where important notions are introduced with practicals where freely available software will be used. While this will not be the focus of the course, we will also introduce and discuss genealogical (coalescent-based) simulation methods and those based on forward-in-time simulations. Altogether this will allow to discuss the potentialities and limitations of the tools available to the community. In this five-day course we will introduce the main concepts that underlie many of the models that are frequently used in population genetics. We will focus on the importance of demographic history (e.g. effective sizes and migration patterns) in shaping genetic data. We will go through the basic notions that are central to population genetics, insisting particularly on the statistics used to measure genetic diversity and population differentiation. The course will also cover a short introduction to coalescent theory, Bayesian inference in population genetics and data simulation. We will also introduce two methods that have been recently developed to analyse genomic data. The PSMC of Li and Durbin reconstructs the demographic history of a species or population with the genome of a single individual. The Rehh package is an R implementation of the Extended Haplotype Homozygosity (EHH) test for selective sweeps and looks for signals of selection based on the analysis of genomic regions. Most theory will be put into practice in practical sessions, analyzing real and/or simulated datasets. In these sessions, we will look at measures of genetic diversity and differentiation and use methods to infer demographic history. We will learn how to perform coalescent simulations of genetic/genomic data (using SPAms and ms). We will also show how to simulated data for PSMC analyses. This will allow users to compare the PSMC obtained with real data to those obtained for the models they used. We will also look at how habitat fragmentation can be simulated using an in-house program. Some exercises will make use of R scripts (R being a freely available statistical program). Basic R knowledge is a pre-requisite but we will provide a short introduction to R. The R statistical package is a very powerful tool to analyse data outputs from many population genetics software, and can also be used to simulate genetic data under simple demographic scenarios. Course Pre-requisites Basic molecular population genetics and molecular ecology. Basic R knowldedge. Basic knowledge of genomic data. 2017-03-13 09:30:00 UTC 2017-03-13 09:30:00 UTC Pedro Fernandes Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal 2781-901 Genomics Population genetics [] bicourses@igc.gulbenkian.pt [] [] 20 workshops_and_courses registration_of_interest []
  • ADER17 - Analysis of Differential Expression with RNAseq

    17 April 2017

    Oeiras, Portugal

    Elixir node event
    ADER17 - Analysis of Differential Expression with RNAseq https://tess.elixir-europe.org/events/ader17-analysis-of-differential-expression-with-rnaseq    IMPORTANT DATES for this Course   Deadline for applications: April 10th 2017   Course dates: April 17th - April 20th 2017 Candidates with adequate profile will be accepted in the next 72 hours after the application, until we reach 20 participants. Course description Overview High-throughput technologies allow us to detect transcripts present in a cell or tissue. This course covers practical aspects of the analysis of differential gene expression by RNAseq. Participants will be presented with real world examples and work with them in the training room, covering all the steps of RNAseq analysis, from planning the gathering of sequence data to the generation of tables of differentially expressed gene lists and visualization of results. We we will also cover some of the initial steps of secondary analysis, such as functional enrichment of the obtained gene lists. Target Audiences Life Scientists who want to be able to use NGS data to evaluate gene expression (RNAseq). Computational researchers that wish to get acquainted with the concepts and methodologies used in RNAseq are also welcome. Participants are encouraged to bring their own data and will have the opportunity to apply the concepts learned in the course. Pre-requisites Familiarity with elementary statistics and a few basics of scripting in R. Please have a look at the following resources and gauge your ability to use R in statitics at the basic level: Introduction to Data Science with R Videos from Coursera's four week course in R Statistics at Square One - BMJ Basic Unix command line skills, such as being able to navigate in a directory tree and copy files. See, for example, "Session 1" of the Software Carpentry training for a Unix introduction (Shell-novice material from the Software Carpentry Foundation). 2017-04-17 07:30:00 UTC 2017-04-17 07:30:00 UTC Pedro Fernandes Instituto Gulbenkian de Ciência, Oeiras, Portugal Instituto Gulbenkian de Ciência Oeiras Portugal 1000-029 Transcriptomics RNA-Seq [] bicourses@igc.gulbenkian.pt [] [] 20 workshops_and_courses registration_of_interest []
  • Genome assembly and annotation course 2

    19 - 23 June 2017

    Ljubljana, Slovenia

    Elixir node event
    Genome assembly and annotation course 2 https://tess.elixir-europe.org/events/genome-assembly-and-annotation-course-2 ELIXIR Genome assembly and annotation course 2, June 19-23 2017 at the University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia 2017-06-19 09:00:00 UTC 2017-06-23 17:00:00 UTC ELIXIR SI, University of Ljubljana, Faculty of Medicine University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia University of Ljubljana, Faculty of Medicine Ljubljana Slovenia Genomics University of Ljubljana, Faculty of Medicine [] life scientistsResearchersPhD students workshops_and_courses registration_of_interest genomicsassemblytrainingeLearningEeLP
  • Genome Assembly and Annotation

    19 - 23 June 2017

    Ljubljana, Slovenia

    Genome Assembly and Annotation https://tess.elixir-europe.org/events/genome-assembly-and-annotation The course is aimed at researchers interested in learning more about genome assembly and annotation. It will include information useful for both the beginner and the more advanced user. We will start by introducing general concepts and then continue to step-by-step describe all major components of a genome assembly and annotation workflow, from raw data all the way to a final assembled and annotated genome. There will be a mix of lectures and hands-on practical exercises using command line Linux. After the course the participants will be aware of common practices and commonly used tools and be able to run assembly and annotation projects on their own. More information and registration 2017-06-19 10:00:00 UTC 2017-06-23 17:30:00 UTC Ljubljana, Slovenia Ljubljana Slovenia [] [] [] workshops_and_courses [] []
  • 3Gb-TEST NGS Course Ljubljana 2017

    25 - 27 September 2017

    Ljubljana, Slovenia

    3Gb-TEST NGS Course Ljubljana 2017 https://tess.elixir-europe.org/events/3gb-test-ngs-in-a-diagnostic-setting A 3-day course on NGS Ljubljana, Slovenia in the period of 25-27 September 2017. The focus of the course is on clinical diagnostics using exome/genome sequences, variant identification and analysis including afternoon practical sessions. 2017-09-25 08:00:00 UTC 2017-09-27 18:00:00 UTC 3Gb-TEST Best Western Premier Hotel Slon, Ljubljana, Slovenia Best Western Premier Hotel Slon Ljubljana Slovenia Sequencing Exome sequencing Sequence analysis [] J.A.Lopez_Hernandez@lumc.nl In collaboration with RD-Connect [] 100 workshops_and_courses registration_of_interest NGSDiagnosisWESWGSELSI
  • 3GB-TEST Next-Generation Sequencing Course

    25 - 27 September 2017

    Ljubljana, Slovenia

    Elixir node event
    3GB-TEST Next-Generation Sequencing Course https://tess.elixir-europe.org/events/3gb-test-next-generation-sequencing-course A 3-day course on NGS Ljubljana, Slovenia in the period of 25-27 October 2017. The focus of the course is on clinical diagnostics using exome/genome sequences, variant identification and analysis including afternoon practical sessions.   Course page: http://3gb-test.eu/ The post 3GB-TEST Next-Generation Sequencing Course appeared first on Dutch Techcentre for Life Sciences. 2017-09-25 09:00:00 UTC 2017-09-27 00:00:00 UTC Ljubljana, Slovenia, Ljubljana, Slovenia Ljubljana, Slovenia Ljubljana Slovenia [] [] [] workshops_and_courses [] []
  • 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
  • Medical Writing for Pharma, Biotech and Med Devices

    27 - 29 September 2017

    Berlin, Germany

    Medical Writing for Pharma, Biotech and Med Devices https://tess.elixir-europe.org/events/medical-writing-for-pharma-biotech-and-med-devices This medical writing course’s notes and interactive exercises address how to write effective correspondence and reports in support of the company's activities. You will learn how to organize and deliver information for the intended audience, as well as how to write clear and readable documents, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues. 2017-09-27 09:00:00 UTC 2017-09-29 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 workshops_and_courses first_come_first_served R&D SupportMedical WritingSubmissionsQA/QC
  • 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
  • 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
  • Integration of Risk Management Principles and Activities into the Quality System

    16 - 17 October 2017

    Berlin, Germany

    Integration of Risk Management Principles and Activities into the Quality System https://tess.elixir-europe.org/events/integration-of-risk-management-principles-and-activities-into-the-quality-system The regulatory and business requirements for the pharma, diagnostics, and medical-device fields continue to update, blend, overlap, and blur. With these changes, the importance of risk assessment—and risk management—gains higher business and regulatory significance. It now becomes even more important for professionals in these fields to recognize, accept, understand, and respond to these changes —particularly since new regulatory requirements have emerged within this changing environment. The market’s Tolerance for Failure of Drugs, Devices, and IVDs has reduced significantly in recent decades. This reduction reflects a general loss of confidence in the medical industry. The adoption of formal Quality Management Systems (QMS) has recovered some of that confidence, but we must still do more. This course addresses what we can do. 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 quality/production managersengineersauditorsregulatory/quality professionalsclinical/product specialists R&D engineerslaboratory professionalsproduct-development professionals 20 workshops_and_courses first_come_first_served diagnosticsPharmaceuticalMedical DeviceBiotech
  • Filing Variations in the European Union

    18 - 19 October 2017

    Berlin, Germany

    Filing Variations in the European Union https://tess.elixir-europe.org/events/filing-variations-in-the-european-union The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections. The course will also provide the attendee with a thorough knowledge of the following topics: •Overview of the different types of variations and the different procedures for a Marketing Authorizations in the EU •The different types of variations (Type IA, Type IB, Type II) •Variations involving product information •How to deal with unclassified variations •Line extensions •Work-sharing 2017-10-18 09:00:00 UTC 2017-10-19 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 workshops_and_courses [] filing variations and extensionsMarketing Authorizations types of variationsunclassified variationsLine extensions
  • 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 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 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 Medical DeviceRegulatory AffairsQuality Assurance & ControlCompliance Engineering 20 workshops_and_courses [] Process ValidationRiskvalidation planscombination productsMedical Device
  • 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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