EMWA’s Newsletter – November 2024

EMWA’s Newsletter – November 2024

Dear Readers,

Please find below all EMWA’s upcoming activities, both during the conference and beyond.

Happy reading!


Local Hubs for the Virtual November Conference

In the upcoming EMWA Autumn conference, attendees can choose if they wish to join individually or view the virtual content from one of the Local EMWA Hubs together with other delegates. The in-person networking sessions at the Hubs and online will be independent from each other. Although full conference registration is open to EMWA members only, non-members can book to attend on Thursday 7 November at any of the Local EMWA Hubs:

o?? Argentina – Buenos Aires

o?? France – Lyon

o?? Germany – Potsdam

o?? Italy – Milan (see further information below)

o?? Poland – Warsaw

o?? Portugal – Lisbon

o?? Spain – Barcelona

o?? Switzerland – Bern

o?? The Netherlands – Amsterdam

o?? United Kingdom – London

If you are a non-EMWA member, consider joining us for educational seminars on Friday and workshops from Monday onwards.

For more information about Local EMWA Hubs and the entire conference, please check the conference website.


Seminar on Translation

Is your content reaching audiences across languages and cultures?

If you are responsible for adapting content for diverse linguistic, cultural, and regulatory contexts, do not miss the Seminar on Translation on Friday, 8th November. This event is ideal for project managers, communication specialists, medical writers, and anyone managing multilingual content.

What to expect:

Morning: Foundations & Best Practices Hear from experts in the Language Services, Pharma and MedTech industries about essential skills, workflows, and processes for high-quality medical translation.

Afternoon: Key Translation Topics Join breakout sessions on collaboration, translation briefs, tech tools, cultural sensitivity, and tailored approaches to multilingual communication.

This seminar offers actionable strategies for optimizing multilingual projects in healthcare and pharma.

For questions, reach out to Ana Sofia Correia,?Claire Harmer, or Valentina Luridiana. We hope to see you there!


Regulatory Writing Special Interest Group News

The Regulatory Writing SIG will have its first Meet & Share on November 26th at 13h CET, with the topic “Templates for Non-Clinical Studies” and presented by Dr Susan King (Johnson & Johnson). All EMWA members are welcome to join this session. Registration link here.

The Regulatory Writing SIG will have its next regular meeting on December 5th at 13:00 CET. If you are an EMWA member and are interested in participating in future meetings, please check out our LinkedIn group for further information. We look forward to seeing you there!


Communicating with the Public Special Interest Group News

The Communicating with the Public SIG will have its next Meet & Share on December 3rd at 15h CET. This session, presented by Veronica Contreras, will focus on Transparency and the European Medicines Agency (EMA) Policy 0070 and the documents that the medical writer may be involved with: narratives, informed consent forms, and website privacy notifications. To register for this session, click here.


Sustainability Special Interest Group News

Join us at the virtual Expert Seminar Series (ESS) - Sustainability in healthcare - an update/insights for medical writers on Wednesday, November 6, 2024 from 13:30-17:00 CET.

We have a great lineup of speakers who will share their insights on how to drive sustainable changes in healthcare throughout drug development and into clinical practice:

-?????????? Amy Booth, MD, PhD Cand. (University of Oxford)

-?????????? Claudia Percivalle, PhD (AstraZeneca)

-?????????? Dr. Gomotsegang Fred Molelekwa, PhD (Tshwane University of Technology)

-?????????? David Lumby, MPH (Thermo Fisher)

Plus there will be a panel discussion with our speakers and Gemma Rogers, PhD (Oxford PharmaGenesis).

Looking forward to your virtual presence!


Freelance Business Group News

At the 58th EMWA virtual conference, we are hosting the Freelance Business Forum, a free networking session with roundtable discussions on everything related to the freelance medical writer.

As freelancers working on our own, having a community is one of the most important parts of freelancing life, and this event is a great opportunity to meet and connect with other professionals.

It is open to all conference attendees, so whether you are an experienced freelancer, a newcomer or just interested in knowing more about freelancing, join us – there's always something new to learn and share.

Please note that the Freelance Business Forum is free with conference registration, but you have to select it when registering!

Save the date: Friday 8 November, 17:15 - 19:00 CET

In the meantime, if you want to connect, ask questions or provide suggestions, you can join us on the dedicated LinkedIn group EMWA Freelance Business Forum - online.


EMWA Journal News

Journal Print Version – You can opt out and save on paper!

EMWA continues to explore ways of reducing our carbon footprint. Please support us by going into your EMWA profile and indicate your choice? – to opt in/opt out of the print version of MEW. New members are automatically set to opt out.


Getting Into Medical Writing News

The Getting into Medical Writing (GIMW) group is pleased to announce an upcoming Q&A session during which aspiring and new medical writers will be able to join and ask questions to the experts about regulatory writing, med comms, freelancing, and transitioning from academia to medical writing. This 1-hour session will take place on Monday, December 2nd 6 pm CET. It will be available to EMWA members only (registration link coming soon).

We would appreciate it if you could submit your questions in advance to help us tailor the session to your needs.

We look forward to seeing you there,

The GIMW Group


Ambassador Programme News

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

On 8 Oct 2024, Martin Delahunty gave a talk on Careers in Medical Writing and the benefits of joining EMWA at the University of Essex Employability for the Biosciences Workshop. The EMWA presentation was part of a formal assessed assignment where the 35 participating students had to consider the challenges and opportunities for a particular career pathway. This was the first time that students had had a presentation on medical writing and medical communications. Only 3 of the 35 students had previously considered medical writing as a career pathway. Martin fielded questions on the different types of medical writing, possibilities for internships, and the differences between freelance employment and working for an agency. The students were especially interested in the results of the EMWA salary survey. Overall, the event went quite well as Martin did indeed succeed in kindling the interest of the students in a field that they had never heard of before.

The next planned events are described below.

On 7 Nov 2024, Abe Shevack and Peter Llewellyn will? respectively speak about the Ambassador Programme and Networking at the Opening Session of the EMWA Online.

On 15 Nov 2024, Maria Koltowska-Haggerstrom and Catherine Heddle will represent EMWA at Aula Medica Chase Career Conference in Stockholm, Sweden.

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 the EMWA Head Office ([email protected]) or Abe Shevack ([email protected]).


CORE Reference News

CORE Reference Webinar

Wednesday 04 December 2024, 12:30 - 13.45 CEST (11.30 - 12.45 UK time)

Title: EMA Policy 0070 Real Life Experience – Voydeya

Presenters: Raquel Billiones, PhD and Alison McIntosh, PhD for the CORE Reference Team?

Register?here.

The next CORE Reference webinar will focus on preparing an EMA Policy 0070 Anonymisation Report (AnR), using examples from the Voydeya submission completed in Spring 2024 and with clinical data published on 26 June 2024. Members of the CORE Reference team will discuss specific challenges presented by rare diseases, including selection of appropriate anonymisation methods and will outline some of the problems challenges this poses with maintaining data utility. The webinar will also cover interactions with the EMA and present some? lessons learned from the Voydeya anonymisation process.

This webinar will:

  • Provide a brief overview of the Policy 0070 AnR and associated anonymisation methodology
  • Outline challenges presented by rare diseases as illustrated by the Voydeya submission
  • Outline challenges posed in maintaining data utility?
  • Review interactions with EMA including the pre-submission meeting
  • Discuss challenges and learnings from the Voydeya anonymisation process.?

Previous related presentation: The CORE Reference webinar on 7 June 2024 included a general introduction to the Policy 0070 Anonymisation Report (AnR) Template. For details, see?https://www.core-reference.org/media/1088/core-reference-seminar-emwa-valencia-may-2024-and-webinar-07-june-2024-slides.pdf?(refer to webinar slides 21 – 37 or?presentation video?at 30 – 58 minutes).?

CORE Reference September News Summary

Check out the?September 2024?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 September 2024 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.


10th International Congress on Peer Review and Scientific Publication

Call for Abstracts announced for the?10th International Congress on Peer Review and Scientific Publication. See?JAMA?and?BMJ. Abstracts can be submitted December 1, 2024 through January 25, 2025.

The aim of the Congress is to encourage research into the quality and credibility of peer review and scientific publication and to further the evidence base on which scientists can improve the conduct, reporting, and dissemination of scientific research. The 10th Congress will be held September 3-5, 2025, in Chicago. For more information, visit the?Peer Review Congress website.


要查看或添加评论,请登录

European Medical Writers Association (EMWA)的更多文章