EMWA’s Newsletter – August 2023

Hi there,

Summer is in full swing in the Northern hemisphere, but EMWA is not on holiday! Continue reading to know more about our upcoming activities ??

EMWA's Support for Medical Writers in Europe

As mentioned in the June newsletter, we are pleased to announce EMWA's support for medical writers in Europe who form networking groups within their country or local region. Such groups can be in the form of local EMWA groups (LEGs) or independent national associations of medical writers that are established as separate legal entities. Both are designed to facilitate local networking, discussions, information sharing and the dissemination of best practices in a given European country or geographic area.

If your local group of medical writers (LEG or independent association) wishes to be included in a network of medical writing groups across Europe, please contact EMWA Head Office ([email protected]) to be part of the mailing list to hear about current and upcoming activities and inform our members about events in your region via our regular EMWA newsletters.

CORE Reference

Check out the?June 2023?list of ICH, EMA (including CTR and CTIS), FDA and other regional guidances; best practice documents; and other tools and resources supporting clinical trial reporting; transparency and disclosure of clinical documents; real world data and artificial intelligence/machine learning in the regulation of medicines. The CORE Reference NewsSummary encompasses medicines, vaccines and devices; information is archived (including the July 2023 NewsSummary in the coming days) at:?https://www.core-reference.org/news-summaries/. Sign up for the bi-monthly email service here:?https://www.core-reference.org/subscribe.

Communicating with the Public SIG - Meet & Share

On Wednesday 20 September 2023 the CwP SIG are hosting a Meet & Share session entitled?“Protecting the public from undue harm during research studies.”

Alison Rapley and Art Gertel will share their experience of working with ethics committees.?Alison and Art will briefly discuss the role of the Ethics Committee and why writing for the public is an important part of an ethics submission with particular emphasis on the need to use language understandable by the lay person to prepare the application and the participant facing documents such as the Patient Information Sheet,?the Informed Consent Form and other documents such as recruitment posters and diaries. In addition, they will consider how decentralised trial materials may differ from those in a traditional, site-based setting.

Please register for this session by sending an email to EMWA:?[email protected]. We will confirm your registration?and send a calendar invite with the zoom details.?

This meeting is for EMWA members only, so please ensure your membership is up to date to attend this meeting.?

For more information on the Communicating with the Public?Special Interest Group,?please visit our?website.?

Ambassadors Programme News

The?EMWA Ambassador Programme’s?is continuing its efforts to reach out to new audiences to promote medical writing and EMWA and has supported the following events.

On?21 June?to Andrea Rossi gave a presentation on careers in medical writing at the University of Florence yearly career event. Andrea and Joanna Chester also represented EMWA at a booth during the event with other companies and associations. Those in attendance were quite interested and it was a very active event. Andrea is looking forward to attending next year and also improving promotion for this event.

On?20 Sep 2023?Gokce Ayan, a new member of EMWA, will give a talk about her transition to medical writing and the benefits of joining at the Max Panck Institute for Evolutionary Biology Postdoc Retreat taking place in Pl?n, Germany.?

On?22 Sep 2023?Abe Shevack will give a brief introduction to the Ambassador Programme at the Getting into MW online Session which again promises to be a well-attended event organized by Evguenia Alechine.?

On?25 Sept 2023?Sarah Choudhury, Arunon Sivananthan and Ricardo Milho will again represent EMWA as exhibitors at the NetworkPharma Medcomms Careers Event being organized by Peter Llewellyn at the Heathrow Conference Centre. This event was very well attended last year with over 500 participants and a couple of medcomms companies at this event managed to attend and sponsor the EMWA Fall Conference in Prague which had a record number of sponsors and attendees.?

On?16 Oct 2023?Arunon Sivananthan will represent EMWA at?the Kings College Career and Employability Event in London. We have now registered and look forward to this new and exciting opportunity for us to introduce students to the field of MW and the benefits of joining our organization.

If you are an experienced medical writer and EMWA volunteer and are interested in becoming an EMWA Ambassador or if you know of any upcoming career events in your locality, please contact Abe Shevack ([email protected]).

Useful Resources for Medical Writers

JAMA published an article advising on the responsible use of AI tools: JAMA Network Guidance for Authors, Peer Reviewers, and Editors on the Use of AI.