Introduzione

Medical writing covers a broad spectrum of activities, ranging from preparing clinical study documentation to presenting scientific data in peer-reviewed journal articles and other formats (e.g., posters, web copy, presentations, etc.). These activities are time-consuming and require specialist knowledge and skills. Importantly, biomedical research is governed by written documents, and researchers from academia and the pharma industry are obliged to publish their results. However, many researchers lack the time, skills, or familiarity with medical writing rules and guidelines to fulfil these writing tasks. Such an environment creates a demand for medical writing support, usually provided by freelancers or specialized agencies.
This course aims to set the scene for efficient collaboration between an author and medical writer, facilitating smooth and rapid progress in developing manuscripts or other documents, defining realistic expectations, and improving understanding of mutual needs. It will start with an introduction to the medical writing world, followed by an analysis of the particular requirements and main criteria for selecting a medical writing provider. Finally, the course will outline critical issues in securing beneficial collaboration between authors and medical writers.
So if you require support in medical writing, either as an academic or professional from medical or clinical departments in the pharma industry or a clinical research organization (CRO), this training session is for you!

Module 1: Medical writing and medical writing providers

  • Introduction to medical writing – types (agencies, freelancers), rules and guidelines
  • Medical writing agencies – structure and specifics

Module 2: Customers of medical writing providers

  • Types of customers
  • Analysis of customers’ needs
  • Selection of a medical writing provider
  • Managing customers’ expectations

Module 3: Collaboration between a customer/author and medical writing provider

  • Agreements and other formal documents
  • Setting the scope of collaboration
  • Role of the medical writing provider
  • Specifics of regulatory writing
  • Editing papers and submission support
  • Medical communication – who does what

Pharmaceutical companies, medical devices manufacturers, CROs and anyone needing to subcontract medical writing services who wishes to better understand how to get the most out of the chosen provider.

Participant experience

No particular participant experience is formally required, but basic knowledge about writing publications and clinical study documentation will be helpful.

Online interactive training, comprising discussions, group exercises and Q&A.

Docente/i
Maria Koltowska-Häggström
Info

Maria Koltowska-Häggström

Co-owner - Proper Medical Writing
Maria Kołtowska-Häggström, MD, PhD is a co-owner of Proper Medical Writing, the first Polish medical writing agency, and an independent consultant, affiliated to the Department of Women’s and Children’s Health at Uppsala University, Uppsala, Sweden. After completing her medical studies in Wrocław, Poland, Maria worked for ten years as a paediatrician. In 1991, she began working within the pharmaceutical industry where she gained experience in both the marketing and medical sides of the business. Between 2001 and 2013, Maria worked at Pharmacia (later Pfizer) in Stockholm, Sweden, where she held various responsibilities for large research databases. Maria was a leading member of numerous research groups investigating growth hormone disorders in paediatric and adult patients managed in the real-life clinical setting. She has an extensive track record of quality of life and patient-reported outcomes research. She has also gained a wide experience in different ways of data presentation i.e. oral and poster presentations as well as publications. Furthermore, she lectured at different meetings related to late phase drug development and data management and drug safety evaluation. She is a member of the European Medical Writers Association (EMWA), European Association of Scientific Editors (EASE), European Society of Endocrinology (ESE), and Growth Hormone Research Society (GRS). As a long-time EMWA member, Maria is a trainer and a workshop leader, section editor for Medical Writing and a chair of the Expert Seminar Series Organizing Committee.

This online training is divided in 3 modules:

Module 1 | June 07th, 2021 – 2:00 pm – 4:30 pm CET
Module 2 | June 08th, 2021 – 2:00 pm – 4:30 pm CET
Module 3 | June 10th, 2021 – 2:00 pm – 5:00 pm CET

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 880,00(until 10 May 2021)

Ordinary: € 1.070,00*

Freelance – Academy – Public Administration**: € 570,00*

for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Acquista
Early Bird
Acquistabile fino al 10/05/2021
880,00
Ordinary
Acquistabile fino al 07/06/2021
1.070,00
Freelance - Academy - Public Administration
Acquistabile fino al 07/06/2021
570,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Navigate the medical writing world
Risultato atteso
Specify your needs
Risultato atteso
Select the most appropriate medical writing provider
Risultato atteso
Formally set up a collaboration, considering all legal and logistical requirements, etc.
Risultato atteso
Set realistic expectations and effectively manage them

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>