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  • Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

    2 - 3 October 2012

    Philadelphia, United States of America

    Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products https://tess.elixir-europe.org/events/aseptic-processing-in-the-manufacture-of-biotech-and-pharmaceutical-products 2012-10-02 09:00:00 UTC 2012-10-03 00:00:00 UTC The Center for Professional Innovation & Education Doubletree Hotel by Hilton, Philadelphia, United States of America Doubletree Hotel by Hilton Philadelphia United States of America Pharmacology [] [] [] workshops_and_courses [] Microbiology
  • Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

    5 - 6 October 2012

    Philadelphia, United States of America

    Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences https://tess.elixir-europe.org/events/japan-regulatory-filing-requirements-and-compliance-processes-for-life-sciences-d60fc15c-89b5-4d39-a6cd-1af4fa9d5569 2012-10-05 09:00:00 UTC 2012-10-06 00:00:00 UTC The Center for Professional Innovation & Education Doubletree Hotel by Hilton, Philadelphia, United States of America Doubletree Hotel by Hilton Philadelphia United States of America [] [] [] workshops_and_courses [] []
  • Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products

    12 - 13 October 2012

    Berlin, Germany

    Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products https://tess.elixir-europe.org/events/comprehensive-overview-of-fda-regulatory-compliance-for-drug-and-biotech-products 2012-10-12 00:00:00 UTC 2012-10-13 00:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany [] [] [] workshops_and_courses [] Biotechnology
  • QA/QC Strategy for Biologics and Biopharmaceuticals

    18 - 20 October 2012

    Philadelphia, United States of America

    QA/QC Strategy for Biologics and Biopharmaceuticals https://tess.elixir-europe.org/events/qa-qc-strategy-for-biologics-and-biopharmaceuticals 2012-10-18 09:00:00 UTC 2012-10-20 00:00:00 UTC The Center for Professional Innovation & Education Philadelphia, United States of America Philadelphia United States of America Pharmacology [] [] [] meetings_and_conferences [] []
  • Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products

    23 - 24 October 2012

    Philadelphia, United States of America

    Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products https://tess.elixir-europe.org/events/analytical-method-validation-for-biologics-biopharmaceuticals-and-other-therapeutic-products-03eb426a-1936-4302-87a4-daa4d64f42cf 2012-10-23 09:00:00 UTC 2012-10-24 00:00:00 UTC The Center for Professional Innovation & Education Doubletree Hotel by Hilton, Philadelphia, United States of America Doubletree Hotel by Hilton Philadelphia United States of America Pharmacology [] [] [] meetings_and_conferences [] []
  • Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

    3 - 4 October 2013

    Philadelphia, United States of America

    Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences https://tess.elixir-europe.org/events/japan-regulatory-filing-requirements-and-compliance-processes-for-life-sciences 2013-10-03 01:00:00 UTC 2013-10-04 01:00:00 UTC The Center for Professional Innovation & Education Doubletree Hotel by Hilton, Philadelphia, United States of America Doubletree Hotel by Hilton Philadelphia United States of America Pharmacology Medicine [] [] [] workshops_and_courses [] []
  • ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development

    4 - 6 November 2013

    Berlin, Germany

    ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development https://tess.elixir-europe.org/events/adme-pk-tk-and-drug-metabolism-in-drug-discovery-and-development 2013-11-04 00:00:00 UTC 2013-11-06 00:00:00 UTC The Center for Professional Innovation & Education Berlin, Germany Berlin Germany Pharmacology Medicine [] [] [] workshops_and_courses [] []
  • Process Validation for Drugs and Biologics

    11 - 12 November 2013

    Berlin, Germany

    Process Validation for Drugs and Biologics https://tess.elixir-europe.org/events/process-validation-for-drugs-and-biologics 2013-11-11 00:00:00 UTC 2013-11-12 00:00:00 UTC The Center for Professional Innovation & Education Berlin, Germany Berlin Germany Pharmacology Medicine [] [] [] meetings_and_conferences [] []
  • Good Manufacturing Practices

    13 - 15 November 2013

    Berlin, Germany

    Good Manufacturing Practices https://tess.elixir-europe.org/events/good-manufacturing-practices 2013-11-13 00:00:00 UTC 2013-11-15 00:00:00 UTC The Center for Professional Innovation & Education The Burlington Hotel, Berlin, Germany The Burlington Hotel Berlin Germany Pharmacology [] [] [] workshops_and_courses [] Biotechnology
  • 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
  • Water Purification Systems for Regulated Industries

    23 - 24 October 2017

    Berlin, Germany

    Water Purification Systems for Regulated Industries 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 [] info@cfpie.com 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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