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View this email in your browser Registration is now open for the 45th EMWA conference in Cascais, Portugal that will be held on the 2 - 4 November 2017 Workshops are filling up quickly! Don’t forget, if you register for any for-credit workshops, you will need to download the pre- workshop assignment from the dedicated conference minisite. Call for Abstracts - 46th EMWA Conference, Barcelona 2018 The Scientific Organising Committee calling for abstract submissions for the 46th Annual EMWA Conference in Barcelona, Spain, until the 15th December 2017. Posters based on accepted abstracts will be displayed at the conference from 2ndto 4th May 2018. More info here Love Webinars? Join our team! EMWA is looking for 3 or 4 volunteers to join the Webinar volunteer team. If you have experience of running/presenting webinars or developing eLearning materials, we would love to hear from you. This is a concrete opportunity to help EMWA make meaningful and significant progress in this area and make your voice heard. Interested, or any questions, please contact Laurence Auffret at [email protected] Webinar programme Our first autumn webinar will take place on Tuesday 17th October @1pm CET with Beatrix Doerr's presentation on "Writing clinical study reports for medical devices", a practical and step-by-step guide on how to write a clinical study report for a medical device. Registration opening soon on https://www.emwa.org/training/emwa- webinars-programme/. EMA Policy update An update to the EMA Policy on the publication of clinical data for medicinal products for human use was published on the 22nd of September and is available here. This document provides guidance on the procedural aspects of the submission of clinical re-ports, the anonymization of clinical reports, and the identication and redaction of commercially condential information in clinical reports. The 11th stakeholder forum on pharmacovigilance legislation (21/09/2017) This forum brings together regulators with patients, healthcare professionals, and industry. The agenda for this event is available here. Presentations and video recording will be made availa-ble here. Periodic Safety Update Reports (PSUR) roadmap: A joint industry/assessor training (22/09/2017) - broadcast This joint industry/assessor PSUR training broadcast is aimed at achieving a common under-standing of the role of PSURs in a product’s lifecycle. Topics covered include: signals, close monitoring, safety specication, product information / reference safety information, and the use of summary tabulations. The video recording of the event will be made available here. EMA’s rst public hearing on valproate (27/09/2017) - broadcast European citizens representing patients, carers, healthcare professionals, and academia shared their experience with valproate. The agenda for this event is available here. Further information is available here. EMWA has now undertaken to translate the Joint Position Statement on the Role of Medical Writers. As you remember this statement was prepared together with our colleagues at AMWA and ISMPP in order to set out ethical standards for medical writers in developing scientific and medical publications We are now attempting to spread the word among non-native English speakers in Europe. The document will be translated into German, Italian, French, and Spanish and posted on the EMWA website once a month starting in September. The Italian translation is now available under the following link. Have you subscribed to the EMWA’s YouTube Channel? The “Introduction to Medical Writing” webinar by Dr. Helen Baldwin is available. It is aimed at those considering a career in medical writing. It is of interest to those who have recently joined the profession and who would like to know more. Registered Office: Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY Tel: +44(0)1625 664534 Fax: +44(0)1625 664510 E-mail: [email protected] A Private Limited Company registered in England and Wales No: 03653609 Copyright © 2017 European Medical Writers Association, All rights reserved. Want to change how you receive these emails? You can update your preferences or unsubscribe from this list Click Here to Register Translate

Registration is now open for the 45th EMWA conference in ... · T h e 11th sta k e h olde r f or u m on p h a r m a covigila n ce le gisla tion ( 21/ 09/ 2017) T h i s f oru m b ri

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Page 1: Registration is now open for the 45th EMWA conference in ... · T h e 11th sta k e h olde r f or u m on p h a r m a covigila n ce le gisla tion ( 21/ 09/ 2017) T h i s f oru m b ri

View this email in your browser

Registration is now open for the 45th EMWA conference inCascais Portugal that will be held on the 2 - 4 November

2017

Workshops are filling up quickly Donrsquot forget if you register forany for-credit workshops you will need to download the pre-

workshop assignment from the dedicated conference minisite

Call for Abstracts - 46th EMWAConference Barcelona 2018 The Scientific Organising Committeecalling for abstract submissions forthe 46th Annual EMWA Conferencein Barcelona Spain until the 15thDecember 2017 Posters based on accepted abstractswill be displayed at the conferencefrom 2ndto 4th May 2018 More infohere

Love Webinars Join our team EMWA is looking for 3 or 4 volunteers tojoin the Webinar volunteer team If youhave experience of runningpresentingwebinars or developing eLearningmaterials we would love to hear from you This is a concrete opportunity to helpEMWA make meaningful and significantprogress in this area and make your voiceheard Interested or any questions pleasecontact Laurence Auffret atwebinaremwaorg

Webinar programme Our first autumn webinar will take place onTuesday 17th October 1pm CET withBeatrix Doerrs presentation on Writingclinical study reports for medicaldevices a practical and step-by-stepguide on how to write a clinical studyreport for a medical device Registration opening soon onhttpswwwemwaorgtrainingemwa-webinars-programme

EMA Policy update An update to the EMA Policy on the publication of clinical data for medicinalproducts for human use was published on the 22nd of September and isavailable here This document provides guidance on the procedural aspects of the submissionof clinical re-ports the anonymization of clinical reports and the identicationand redaction of commercially condential information in clinical reports The 11th stakeholder forum on pharmacovigilance legislation (21092017) This forum brings together regulators with patients healthcare professionalsand industry The agenda for this event is available here Presentations and video recordingwill be made availa-ble here

Periodic Safety Update Reports (PSUR) roadmap A joint industryassessortraining (22092017) - broadcast This joint industryassessor PSUR training broadcast is aimed at achieving acommon under-standing of the role of PSURs in a productrsquos lifecycle Topics covered include signals close monitoring safety specication productinformation reference safety information and the use of summarytabulations The video recording of the event will be made available here EMArsquos rst public hearing on valproate (27092017) - broadcast European citizens representing patients carers healthcare professionals andacademia shared their experience with valproate The agenda for this event is available here Further information is availablehere

EMWA has now undertaken totranslate the Joint PositionStatement on the Role of MedicalWriters As you remember this statement wasprepared together with ourcolleagues at AMWA and ISMPP inorder to set out ethical standards formedical writers in developingscientific and medical publications We are now attempting to spread theword among non-native Englishspeakers in Europe The documentwill be translated into GermanItalian French and Spanish andposted on the EMWA website once amonth starting in September TheItalian translation is now availableunder the following link

Have you subscribed to the EMWArsquos YouTube Channel

The ldquoIntroduction to Medical Writingrdquowebinar by Dr Helen Baldwin isavailable It is aimed at thoseconsidering a career in medicalwriting It is of interest to those who haverecently joined the profession andwho would like to know more

Registered Office Chester House 68 Chestergate Macclesfield Cheshire SK11 6DY Tel +44(0)1625 664534 Fax +44(0)1625 664510 E-mail infoemwaorg A Private Limited Company registered in England and Wales No 03653609

Copyright copy 2017 European Medical Writers Association All rights reserved

Want to change how you receive these emails

You can update your preferences or unsubscribe from this list

Click Here to Register

Translate