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7 events found

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Target audience: postdoctoral researchers  or Medical Device 

  • 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
  • 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
  • Multiple Sequence Alignment with Jalview and Protein Structure and Function Modelling

    14 - 15 May 2018

    Liverpool, United Kingdom

    Elixir node event
    Multiple Sequence Alignment with Jalview and Protein Structure and Function Modelling https://tess.elixir-europe.org/events/multiple-sequence-alignment-with-jalview-and-protein-structure-and-function Date: Monday 14th to Tuesday 15th May 2018 Time: 9.00 to 17.00 Location: MSTC, Sherrington Building, University of Liverpool, L69 3BX Overview This two day hands-on training course is aimed at students and researchers who want to gain practical understanding of the tools and approaches for protein sequence, structure and function prediction and analysis. In day 1, participants will be introduced to Jalview - a free desktop application for the visualisation and comparative analysis of protein, DNA and RNA sequences. Jalview can integrate data from Ensembl, Uniprot, PDBe, Rfam and Pfam, and can access a range of tools for multiple sequence alignment, conservation analysis and secondary structure and disorder prediction, including the widely used JPred4. On the second day, participants will learn to use Jalview’s 3D structure visualisation capabilities in conjunction with UCSF Chimera, and take a whistle-stop tour of the methodologies and tools for prediction and analysis of Protein 3D structure and function. Participants are encouraged to bring their own protein analysis problems and time will be reserved at the end of day 2 for discussion. Register using the link on the Jalview website: http://www.jalview.org/training/training-courses/Multiple-Sequence-Alignment-with-Jalview-and-Protein-Structure-and Day 1: Multiple Sequence Alignment and Analysis with Jalview Workshop trainers: Dr Jim Procter and Dr Suzanne Duce 9 9.15 Introduction to the Workshop 9.15 10.30 Session 1.Loading sequences, structures and alignments with Jalview Coffee break 11 12.30 Session 2. Multiple alignment Creation and Alignment Reliability Lunch 1.30 3pm Session 3. Phylogenetic trees and subfamily analysis of Proteins and CDS Coffee break 3.30 5pm Session 4. Protein secondary structure and disorder prediction, and working with annotation Day 2: Protein Structure Analysis and Modelling Workshop trainers: Dr Jim Procter and Dr Dan Rigden 9 9.15 Introduction to Workshop Day 2 9.15 9.30 Introduction to Protein 3D Structure 9.30 10 Viewing and Comparing 3D structures with Jalview and UCSF Chimera 10 10.30 Mapping sequence conservation to Biological Assemblies with Jalview Coffee Break 11 12.30 Functional analysis of Protein Structures Lunch 1.30 2.30 Homology modelling and model quality evaluation 2.30 3.15 Ab initio models and searching for fold matches 3.15 3.30 Wrap up: Function Analysis and 3D models Coffee Break 4pm 5pm Analyse your own protein sequences and structures. 2018-05-14 09:00:00 UTC 2018-05-15 17:00:00 UTC Dr Jim Procter and Dr Dan Rigden MSTC, Sherrington Building, University of Liverpool, Liverpool, United Kingdom MSTC, Sherrington Building, University of Liverpool Liverpool Merseyside United Kingdom L69 3BX University of Liverpool Dr Jim Procter and Dr Suzanne Duce, School of Life Sciences, University of Dundee, Dundee University of Dundee PhD studentspostdoctoral researchersprinciple investigatorsLife Science Researchersbioinformaticians 45 workshops_and_courses registration_of_interest Jalviewmultiple sequence alignmentMSAprotein sequence protein structure protein predictionHomology modellingAb initio modelsChimerasubfamily analysisPhylogenetic treesProtein secondary structureUniversity of DundeeUniversity of Liverpool
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