Medical Writing Artificial Intelligence and Machine Learning Regulatory Public Disclosure
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Volume 32, Issue 3 - Artificial Intelligence and Machine Learning

Regulatory Public Disclosure

Abstract

Editorial

Sam Hamilton (author and section editor)

Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161

Clinical Data Publication (Policy 0070) relaunch

Alison McIntosh (author)

In preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.

Medical Writing. 2023;32(3):91–92. https://doi.org/10.56012/nnwx9514

Current clinical trial disclosure landscape in Asia

Zuo Yen Lee (author)

The transparency and disclosure landscape in Asia has been rapidly evolving during the past decade. With respect to clinical trial registries, China launched its national registry, ChinaDrugTrials.org.cn, in 2013; South Korea introduced the new clinical trial disclosure platform through its Ministry of Food and Drug Safety (MFDS) in 2019; whilst Japan unified its three existing primary registries into a single clinical trial registry – Japan Registry of Clinical Trials (jRCT) – in 2020. We provide an overview of the national clinical trial registries and the trial results disclosure practices for 4 Asian countries – China, Japan, South Korea, and Taiwan.

Medical Writing. 2023;32(3):96–97. https://doi.org/10.56012/vxbm4667

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Artificial Intelligence and Machine Learning
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President's Message
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Regulatory initiatives for artificial intelligence applications: Regulatory writing implications
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Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD
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A survey on current use of software tools for systematic literature reviews
Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics
AI for medical writers: Friend or foe?
Introducing EMWA’s new AI Working Group
Diversity in clinical trials: It takes a village
News from the EMA
Digital Communication
Medical Communications and Writing for Patients
Good Writing Practice
Regulatory Public Disclosure
Regulatory Matters
Getting Your Foot in the Door
The Crofter: Sustainable Communications

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk