EMWA’s Newsletter – September 2023

Hello all,

This month, we are kicking off our regular offer of events with two Meet & Share presentations, one special session for those wanting to set their foot into the medical writing world, and one webinar, so make sure to save space in your calendar for your favourite event(s)! Please note that most events are for members only, so make sure your membership is up to date or consider becoming a member in order to attend.

We also have our regular update about CORE Reference (and subscribe to their NewsSummary if you haven’t already), as well as a special announcement for medical writers working in Italy ??

Happy reading!

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CORE Reference

Check out the?July 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?August 2023?NewsSummary) at:?https://www.core-reference.org/news-summaries/. Sign up for the bi-monthly email service here:?https://www.core-reference.org/subscribe.

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Communicating with the Public SIG - Meet amp; 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.

Join us to share your questions and experience!

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.?

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Webinar Team and Pharmacovigilance SIG

On September 21st, John Praveen will present a webinar titled “Pharmacovigilance Webinar: Reporting of Adverse Events”.

John Praveen is the Associate Vice President – PV Account Delivery and PV Shared Services Offering Lead at Accenture. He has more than 14 years of experience working with 10+ clients across geographics in PV Project Management and Service Delivery (across Pharmacovigilance, Medical Devices Vigilance, Cosmetovigilance and Nutraceutical Vigilance). He also leads and manages the Business Process Transformation (including technology enabled i.e., macros, RPA, AI and Analytics), E2E Project Transitions, Training and Capability Development and supports with PV Business Development including pre-sales and end to end bid management.

John completed his Bachelors and Master’s Degree in Biological Science and Microbiology & Immunology from St Joseph’s University, Bangalore and PG Diploma in Medical Entomology and Medical Genetics from St Joseph’s University in Bangalore. He also has a management degree from Indian Institute of Management, Lucknow. He is also an Accenture certified Business Advisory Expert.

For more information about this webinar, organised by the webinar team and the PV SIG, please visit EMWA’s webinar programme webpage.

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Pharmacovigilance SIG Meet and Share

On Monday 11th September,?at 14:00 CEST the PV SIG are hosting a Meet & Share session.

Meeting title and information: PV SIG's Meet & Share?PSURs and DSURs - are they the same?

In this Meet & Share, we will address the similarities and differences between PSURs and DSURs. Join us to share your questions and experience!

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 Pharmacovigilance?Special Interest Group,?please visit our?website.?

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Getting into Medical Writing Session September 22nd

We remind you that the Getting into Medical Writing open session is still open for registration. During this 3.5-hour meeting, experienced medical writers, including members of the Executive Committee of EMWA and workshop leaders, will cover the following topics:

·???????? Introduction and types of medical writing

·???????? How to leverage LinkedIn to land your first job

·???????? How to better take advantage of EMWA and its offerings

·???????? Regional networking experiences

·???????? Overview of the November virtual conference and workshops

Aspiring/new medical writers will have the chance to network with other medical writers, ask questions, and connect with colleagues.

A few places are still available. This session is open to members and non-members of EMWA and is free of charge.?It will only take place live. No recording will be available after the event.?

Meeting details:

22nd September 2023 - 14:00-17:30 CEST

To register please click?here.

Looking forward to seeing you there,

Getting into Medical Writing (GIMW) Group

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The Italian Local EMWA Group Regional Hub - 9/10 November in Florence

In association with EMWA’s November Virtual Conference, the recently founded Italian Local EMWA Group (LEG) will hold a regional hub in the breathtaking city of Florence, 9-10 November 2023.

The programme will include local networking opportunities, discussions and information sharing, along with a live streaming of the EMWA conference. We will not miss the opportunity to delight in the local cuisine and wines! Don’t skip this chance to be part of the ever-increasing local network of medical and scientific writers, editors, journalists and translators in Italy.

If you work in Italy and are interested in participating, please write to [email protected].

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News About Regional Hubs

In addition to Italy, there are other countries planning to set up Regional Hubs for the November conference, including France, Portugal, Switzerland, Germany, and Serbia.

There are other countries who expressed their interest too, so keep an eye on this space for further developments!

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Announcement from MEW Guest Editor Jen Bell

I am looking for feature article contributions to the European Medical Writers Association journal December 2023 Biotechnology issue and beyond for subsequent quarterly issue Biotechnology regular sections. I am the guest editor of the December issue and the Biotechnology section editor.

Your article's word count should be about 2500 words. You do not have to be an EMWA member to contribute. You do not have to pay fees for your contribution (published in colour), and you will own the copyright of your article – so you can add it to your writing portfolio, no questions asked. The journal feature articles are open-access.

This is the journal website: https://journal.emwa.org/

Look at the links on the right of the journal web page for Instructions for Authors, the Article Template in Word, and Journal Policies.

Contributions must include your definition of biotechnology (which does vary) and the medical writer's role concerning the content of what you write.