Medical Writing EU Regulations Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers

Volume 29, Issue 3 - EU Regulations

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers

Abstract

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal, greater public transparency of documents, and the creation of plain language summaries of clinical trials for easier understanding by the general public. This article provides an overview of important new regulations and policies, including some new guidances regarding research related to the COVID-19 pandemic. This article also discusses opportunities for medical writers working in the context of a new regulatory environment that requires balancing increased public disclosure of information and greater privacy protections for individuals.

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Articles

Editorial
President's Message
EMWA News
The In Vitro Diagnosgtics Regulation and the role of medicals writers
Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR
Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers
New documents required by the medical device regulation
Risk management plans in the EU: Managing safety concerns
Scientific advice procedures in the EU – an overview ofthe regulatory background
EU software regulations: The new normal or innovation stagnation?
The new PubMed – underestimated regulatory obstacles
Ethical challenges in acknowledging professional writing support
Publication management software for medical writers
Regulatory Matters
News from the EMA
Medical Devices
Medical Communications and Writing for Patients
Getting Your Foot in the Door
Lingua Franca and Beyond
My First Medical Writing
In the Bookstores
Good Writing Practice

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