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
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  firstname.lastname@example.org 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  email@example.com The Center for Professional Innovation & Education PharmaceuticalMedical DeviceBiotech 20 workshops_and_courses  filing variations and extensionsMarketing Authorizations types of variationsunclassified variationsLine extensions
Water Purification Systems for Regulated Industries
23 - 24 October 2017
Berlin, GermanyWater Purification Systems for Regulated Industries https://www.cfpie.com/ProductDetails.aspx?ProductID=287 https://tess.elixir-europe.org/events/water-purification-systems-for-regulated-industries The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications. The course is designed to provide the attendee with a practical understanding of the following topics: •Basic water chemistry •Water quality selection criteria •EPA, EU, and WHO drinking water standards •The governing regulatory agencies with direct impact on water systems •Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups) •Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam) •Pretreatment component equipment - selection and operating principals •Final treatment options (reverse osmosis, vapor compression, single-effect and multiple-effect stills) •Opportunities for energy and water resource conservation •Point of use criteria such as temperature, location, time-of-day, and demand (GPM & GPD) •System design including materials of construction, generation, storage and distribution options •Trend reports (analysis, problem identification, predictive value) •Control systems, data historian, secure access, set points and alarms •Managing performance deviations and component failure •Direct and in-direct impact analysis •Quality by design including risk assessment •Instrument calibration for critical, non-critical, and informational only devices •Maintenance impacts to system performance, reliability, and validation •The importance of as-built documentation - user and field directed changes 2017-10-23 09:00:00 UTC 2017-10-24 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 Regulatory AffairsQualityComplianceR&DValidationManufacturingMaintenanceEngineering 20 workshops_and_courses first_come_first_served water chemistryWater quality water systemsSystem design Pharmacopeia water grades Control systemsInstrument calibration
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