Medical Writing Medical decision making and health technology assessment Regulatory Matters
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Volume 30, Issue 3 - Medical decision making and health technology assessment

Regulatory Matters

Abstract

Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators of cardiac injury and cardiac dysfunction, respectively. Before that, I had done a lot of work in oncology, and I was accustomed to biomarkers such as HER2 that can be used to define a patient population for a given treatment.

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Articles

Medical decision making and health technology assessment
President's Message
From the Editor - Making responsible decisions – every day
EMWA News
Medical decision making at the individual and population level: The increasing role of evidence
Global HTA: Past, present, and future
Early benefit assessment of new drugs: The impact on healthcare in Germany
Decision-making in Slovenian outpatient care: Can financial incentives reduce patient waiting lists?
Patients are decision makers too
Quality patient decision aids to support healthcare decision making
EUPATI: Patient engagement through education as an important contributor to shared decision making
The regulatory-HTA decision-making interface: What the medical writer should know
Communicating the findings of health technology assessments: Considering uncertainty
Reporting health economic evaluations: CHEERS and beyond
The medical writers role in health technology assessment submissions
HTA decision-making: Do ethics matter?
Why would the healthcare industry need a doughnut?
Master protocol studies: Embracing the “new normal”
News from the EMA
Medical Devices
News and Notes from the World of Medical Writing
Regulatory Matters
Veterinary Medical Writing
Medical Communications and Writing for Patients
My First Medical Writing
Good Writing Practice
The Crofter: Sustainable Communications
Out On Our Own

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk