EMWA News
News of interest to medical writers: Health Canada
Health Canada have concluded their "Public Release of Clinical Information" consultation.
New Webeditorials available online
Two new articles deal with preclinical research and the highs and lows of taking CME accredited courses.
2019 Medical Communication Compensation Survey
AMWA invites EMWA members to participate in its survey.
Registered for the conference? Don't forget to sign up for the Double Blind Randomised Dining event.
New self-paying event to replace the traditional gala dinner.
EMWA elections 2019. Have you cast your vote yet?
Voting closes at midnight on Saturday, 23 March 2019.
News of interest to medical writers: EMA guidance for medical devices
The EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices.
Medical Device Special Interest Group (SIG) update
A variety of activities are planned at the upcoming EMWA conference.
Document of interest to medical writers: from lab to patient
The EMA has published a booklet describing the the journey of a centrally authorised medicine.
EMWA Vienna conference posters announced
Accepted abstracts are now available to view on the conference site.
EMWA webinar on oral presentations on 28 February!
Oral presentations: skills to help you survive or even shine! by John Dixon on 28 February from 14:00 to 15:00 CET.
EMWA member registration discount for the "Optimising Interactions with Regulators" meeting
EMWA members receive over 18% discount on registration for this meeting organised by TOPRA.
News of interest to medical writers: Big Data
The role of Big Data for evaluation and supervision of medicines in the EU.
2019 EMWA sponsorship and partnership options are open for booking!
Options available include single sponsorship opportunities and packages.
Ambassador Programme Update
The Ambassador Programme has gotten off to a good start in the New Year.
48th EMWA Conference, 7-11 May 2019, Vienna, Austria
A programme preview is now available on the website.
REMINDER: Freelance Business Survey open until 31 January 2019
Participation is open to all freelance medical writers irrespective of their location or EMWA membership and your help in sharing the link to the survey within your network is much appreciated.
Call for new EMWA Professional Development Committee (EPDC) member
Are you looking for a new role in EMWA for 2019?
The first EMWA webinar of 2019 is on 24 January
Our first EMWA webinar of 2019 is on Thursday 24th of January, from 14:00-15:00 CET by Pablo Mugüerza on "Writing about state-of-the-art medicine".
News of interest to medical writers: clinical trial transparency and disclosure
This paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure with special focus on individual study and submission-related requirements.
The latest issue of Medical Writing is now available
The current issue focuses on patient-reported outcomes (PROs).
News of interest to medical writers: new resources on data sharing
Three new resources released.
EMWA needs you for the Executive Committee! Deadline is 16 January 2019
The open positions for 2019 are: Vice-President, Honorary Secretary, Treasurer, and Public Relations Officer. We welcome applications from any EMWA members who meet the eligibility criteria.
Abstracts for the 48th Annual EMWA Conference in Vienna, Austria
The Scientific Organising Committee invites abstract submissions for the 48th Annual EMWA Conference in Vienna, Austria.
CORE Reference Statement on TransCelerate CSR Template
TransCelerate Biopharma have released a Clinical Study Report (CSR) template (dated November 2018) which is based on ICH E3 and CORE Reference. For further information, read the CORE Reference Press Release on this topic.
News of interest to medical writers: medical devices from the EC
Lots of new documents and guidance on medical devices were launched on the European Commission page recently.
December webinar for EMWA members
Personal branding through social media for medical writers is on 6 December.
New webinar on freelancing now available online
EMWA's outreach for its freelance members: activities and resources.
Best attended EMWA November conference of all time!
A short report on the 47th EMWA Conference held in Warsaw.
Webinar on veterinary medical writing – same but different
Live webinar on 30 October by Sandra Götsch-Schmidt.
REMINDER: EMWA conference registration is still open!
We are pleased to announce that Warsaw Conference registration is now open.
The current issue of Medical Writing is available online
This issue focuses on editing.
Delphi Study Invitation
EMWA members are invited to contribute to the development of a new outcome reporting standard for clinical trial protocols and reports of completed trials, called the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT).
New Webeditorials
Three new articles are available online on topics related to medical writing that have stirred EMWA members to put pen to paper.
REMINDER: Geoff Hall Scholarship 2018
Up to two scholarships are available in memory of one of the founding fathers of EMWA, Geoff Hall, who sadly passed away in 2010.
Webinar for freelance EMWA members and non-members
Our next LIVE webinar will be on Thursday the 27th of September at 14:00 CET and cover EMWA’s outreach for its freelance members: activities and resources.
News of interest to medical writers: UK withdrawal from the EU and clinical trials
Statement from European Commission Directorate-General for Health and Food Safety on the UK withdrawal from the EU and its impact on clinical trials.
New webinar now available online: "Why you shouldn't miss the next EMWA conference!"
EMWA conferences provide a medium for networking, active discussions and extensive cost-effective professional training. It's also an opportunity to benefit from the experiences of other medical writers.
10% discount for referring new members to EMWA
Did you know that existing EMWA members can receive a 10% discount off their next year’s EMWA subscription for referring a new member to EMWA?
Programme preview for the 47th EMWA Conference in Warsaw, November 2018
Provisonal preview now online.
News of interest to medical writers: draft GCP guidelines for advanced therapy medicinal products
The Directorate General for Health and Food Safety wants to give an opportunity for concerned stakeholders to express their views on the GCP requirements that should apply to advanced therapy medicinal products.
Webinar on 30 August - open to all!
Why you shouldn’t miss the next EMWA conference...
The Nick Thompson Fellowship Award
Established in 2001, The Nick Thompson Fellowship Award recognises service to EMWA above and beyond what would normally be expected of members or those who hold or have held elected offices.
New section on the Pharmacovigilance Special Interest Group (PV SIG) page
Newsblast regulatory news is now uploaded to the new subpage of the PV SIG page.
Exclusive webinar on writing guidelines
Our next webinar, exclusively for EMWA members, will be on the 27th July 2018 at 14:00 to 15:00 CET on writing guidelines by Andrea Rossi.
EMWA members receive a 20% discount on Writing High-Quality Medical Publications: A User's Manual
The publisher offers a 20% substantial discount to all EMWA members who order the title.
June issue of Medical Writing on public disclosure
You should soon be receiving the June issue of Medical Writing on public disclosure.
Joint Position Statement – Russian translation now available
The Joint Position Statement on the Role of Medical Writers has now been translated into Russian.
NewsBlast instructions to contributors
We are adapting our format. Read the new guidelines here.
Assistant web manager position
We are looking for an assistant to our web manager.
REMINDER: How to organize and deliver a webinar yourself
Our next webinar, exclusively for EMWA members, will be on the 28th of June at 14:00 CET on how to organize and deliver a webinar yourself by Carolina Rojido.
Latest EMWA member offer: 30% off a PerfectIt licence
EMWA members can now avail of the latest exclusive offer.
News of interest to medical writers: ICMJE's ‘Data Sharing Statement’
As of 01 July 2018, manuscripts submitted to journals following the ICMJE recommendations require an individual participant data (IPD) ‘data sharing statement’
New Webeditorial on healthy medical writing
One issue sometimes overlooked by medical writers, healthcare organisations and even the general population is our own, personal wellbeing.
The General Data Protection Regulation (GDPR)
EMWA has fully embraced the GDPR.
Freelance Business Forum (FBF) report now available
The sub-committee report of the highly successful Freelance Business Forum (FBF) held at the recent 46th EMWA Barcelona is now available.
Webinar on the Joint Position Statement on the Role of Professional Medical Writers
This webinar is a joint educational webinar of ISMPP, AMWA, and EMWA. It will have long-lasting career benefits for writers and managers of writers!
Winners of the photo competition at the Barcelona conference 2018
View the winning photos of EMWA 25th anniversary badges.
The EMWA conference has ended.
Over 400 medical writers enjoyed the 46th EMWA conference in Barcelona.
Joint Position Statement –Ukrainian (Українська) translation now available
We are pleased to inform you of the latest translation of the Joint Position Statement on the Role of Medical Writers.
Joint Position Statement–Hungarian (Magyar) translation now available
The Joint Position Statement on the Role of Medical Writers has now been translated into Hungarian (Magyar).
Reminder: April 10 Deadline approaching for The Board of Editors in the Life Sciences (BELS) examination in Barcelona.
For the second time since 1996 and for the convenience of EMWA members attending the May 2018 Conference in Barcelona, the Board of Editors in the Life Sciences (BELS) is planning to hold its editing proficiency certification examination.
The 46th EMWA Conference is filling up fast!
Six workshops are already full, and nine are nearly full.
Barcelona EMWA conference reporting
EMWA would like to offer an opportunity to delegates attending the 46th Conference in Barcelona to write short news articles about sessions you are attending during the Spring Conference.
News of interest to medical writers: MDR roadmap
The high-level Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap is now available.
Joint Position Statement –Romanian translation now available
EMWA is involved in the translation of the Joint Position Statement on the Role of Medical Writers. This statement was prepared together with our colleagues at AMWA and ISMPP.
Medical Devices Webinar on 13 March - Registration Now Open
Medical Devices: Key Regulations and Guidelines that Medical Writers Should Know.
Upcoming issues of Medical Writing
List of the upcoming issues of Medical Writing and the deadlines for submitting articles.
Opportunity to Vote for Your Next EMWA Executive (EC) Committee Members!
Voting for the next EMWA Executive (EC) Committee Members is now open. Meet successful candidates in Barcelona on 2 May 2018.
The Board of Editors in the Life Sciences (BELS) is planning to hold its examination in Barcelona.
For the second time since 1996 and for the convenience of EMWA members attending the May 2018 Conference in Barcelona, the Board of Editors in the Life Sciences (BELS) is planning to hold its examination in Barcelona.
The EU court backs the EMA position on CCI
On 06 Feb 2018, the EU General Court backed the European Medicines Agency in three cases that challenged the agency's authority to release documents under EU transparency regulations.
Joint Position Statement – Chinese and Japanese translations now available
EMWA is involved in the translation of the Joint Position Statement on the Role of Medical Writers. 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 spreading the word among non-native English speakers in Europe and beyond.
News of interest to medical writers: FDA joins the global push towards publication of trial data through CSRs
The FDA has detailed plans to publish CSRs in a pilot scheme “…to evaluate whether disclosing certain information included within CSRs following approval of a NDA improves public access to drug approval information.”
New Webeditorial: "How To Write An Unsuccessful Web Article"
Tongue firmly in cheek, Evguenia Alechine outlines the ingredients needed for an unsuccessful web article.
Over 10,000 CORE Reference downloads
CORE (Clarity and Openness in Reporting: E3-based) Reference is a user manual to help medical writers navigate relevant guidelines as they create clinical study report (CSR) content relevant for today’s studies. It was developed by a team of EMWA and AMWA volunteers.
Medical Writing issue on nonclinical and preclinical studies
The latest issue of Medical Writing on nonclinical and preclinical studies is now available.
Ambassador’s program
European Medical Writers Association has organized an Ambassador’s program where experienced EMWA members will be speaking at career events at universities, career planning days or seminars in Europe.
EMWA needs you for your Executive Committee!
I would like to take this opportunity to remind you of the forthcoming elections for positions in the Executive Committee (EC). The positions are: Vice-President, Education Officer and Conference Director. We welcome applications from any EMWA members who meet the eligibility criteria.
News of interest to medical writers: ICMJE Recommendations updated
The International Committee of Medical Journal Editors has updated the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
New members needed for the EPDC
We are looking for 2 new members. One will be our lead on webinars, which will include leading the small team of volunteers who are working on webinar presentations and the forthcoming programme. The other member will focus on the workshops, including mentoring workshop leaders who are developing new topics.
Registration Discount Offer for 2018 European Meeting of ISMPP
ISMPP will hold its 2018 European Meeting, Advancing Medical Publications in a Complex Evidence Ecosystem, on 23-24 January, in London
EMWA's 25th Anniversary - call for old photos
On the occasion of EMWA’s 25th anniversary, we are looking to post some amusing pictures from past conferences on the website. If you have pictures that you would like to share, please send them to webmanager@emwa.org. Thanks for your help!
REMINDER: Call for Abstracts - 46th EMWA Conference, Barcelona, 2018
The Scientific Organising Committee invite abstract submissions for the 46th Annual EMWA Conference in Barcelona, Spain. Posters based on accepted abstracts will be displayed at the conference from 2nd to 4th May 2018. Abstracts must be submitted by 15th December 2017!
Recollections and Accomplishments of former EMWA Presidents
The Roman historian Diogenes Laertius once said, “There is nothing permanent except change.” This certainly pertains to EMWA as we celebrate our 25th year. EMWA’s first meeting in 1992 as recounted by former President Geoff Hall, was a small affair attended by only 32 people with no workshops.
New Webeditorial: 6 pitfalls anyone starting out as a medical writer should be aware of
The latest EMWA Webeditorial is now available and it is aimed at people new to the industry.
News of interest to medical writers: EMA relocation
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands.
Report on the 45th EMWA conference in Portugal
The 45th EMWA Conference was held in Cascais, Portugal, from 2 to 4 November 2017. The shorter format autumn meeting was a resounding success.
New ICH guidance on the CTD is available
ICH Guidance on CTD M4 Organization The ICH Guidance on "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" dated October 2017 is available now at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm073257.pdf
Joint Position Statement – French translation now available
EMWA has now undertaken to translate the Joint Position Statement on the Role of Medical Writers. 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 spreading the word among non-native English speakers in Europe and beyond.
The Autumn issue of Medical Writing is now online
Volume 26, Issue 3 - Observational Studies
New Webeditorial on the Medical Device Regulations
The most recent Webeditorial is by Jane Edwards and examines the impact of the new Medical Device Regulations on medical writers.
Joint Position Statement - Italian translation now available
EMWA has now undertaken to translate the Joint Position Statement on the Role of Medical Writers.
Terminology Call for Public Review Package P32
CDISC Controlled Terminology Package 32 is ready for public review. When the public review period ends, this page will be made unavailable. The public review package consists of 13 documents
Joint Position Statement - German Translation
EMWA has now undertaken to translate the Joint Position Statement on the Role of Medical Writers.
Reminder: Geoff Hall Scholarships 2017
Up to two scholarships are available in memory of one of the founding fathers of EMWA, Geoff Hall, who sadly passed away in 2010.
News of interest to medical writers: data sharing statements for clinical trials
News of interest to medical writers: data sharing statements for clinical trials
EMWA 2017 Nick Thompson Fellowship Award
Established in 2001, The Nick Thompson Fellowship Award recognises service to EMWA above and beyond what would normally be expected of members or those who hold or have held elected offices.
The new EMWA website is live! Faster, more legible and mobile responsive!
You may have already noticed the improvements made to the EMWA website caused by switching over to a new platform. Although the new website looks very similar to the old one, there is a marked difference in the speed and responsiveness of the website.
EMA clinical data website survey
EMWA would like to draw attention to the fact that the European Medicines Agency (EMA) has launched a survey to collect feedback from users of EMA's clinical data website.
Medical Writing, Issue 2, 2017, is now online
The latest issue of Medical Writing, on medical devices, is now available.