Introduction to Effective Medical Writing
25 - 26 September 2017
Berlin, GermanyIntroduction to Effective Medical Writing https://www.cfpie.com/ProductDetails.aspx?ProductID=241 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 firstname.lastname@example.org 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, GermanyMedical Writing for Pharma, Biotech and Med Devices https://www.cfpie.com/ProductDetails.aspx?ProductID=254 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  email@example.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, GermanyMedical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications https://www.cfpie.com/ProductDetails.aspx?ProductID=265 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  firstname.lastname@example.org 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, GermanyEuropean Union Regulatory Issues - New Product Development https://www.cfpie.com/ProductDetails.aspx?ProductID=280 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  email@example.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, GermanyFiling Variations in the European Union https://www.cfpie.com/ProductDetails.aspx?ProductID=279 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  firstname.lastname@example.org 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, GermanyMedical Device Validation Training for Professionals https://www.cfpie.com/ProductDetails.aspx?ProductID=261 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  email@example.com The Center for Professional Innovation & Education Medical DeviceRegulatory AffairsQuality Assurance & ControlCompliance Engineering 20 workshops_and_courses  Process ValidationRiskvalidation planscombination productsMedical Device
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