Medical Writing (Advanced)

Cluster

Research and Valorization

Competences as defined in ResearchComp

ResearchComp is a European competency framework developed by the European Commission. It provides a common reference framework that makes researchers’ competencies more visible and comparable—not only for researchers themselves, but also for universities, employers, and policymakers across Europe.

To get started with ResearchComp, you can consult this guide.

Competence Area Competences
Cognitive Abilities

 Abstract thinking;Analytical thinking;Creativity / innovative thinking;Critical thinking;Problem‑solving;Strategic thinking;Systemic thinking;
Doing Research   Academic writing & scientific reporting;Applying scientific research methods;Disciplinary research expertise;Formulating research questions;Interdisciplinary work;Research ethics & integrity;
Managing Research  Evaluating research quality;Leadership in research settings;Project planning & management;Negotiation and conflict management;Supervising or mentoring others;
Managing Research Tools  Open science practices;Research data management;Use of research software & digital tools;
Making an Impact  Communicating science to the public;Innovation & knowledge transfer;Policy engagement & societal impact;Publishing & disseminating research results;
Working with Others
 Teamwork & collaboration;Networking & professional interaction;Building mentor–mentee relationships;Managing intercultural communication;
Self-Management  Career management & development;Lifelong learning;Resilience & coping with pressure;Self‑organization & planning;Time management;

Target audience

PhD students in a scientific discipline (eg, biological, veterinary, pharmaceutical, medical sciences, biochemistry, biotechnology) at any stage of completion, with an interest in writing and clinical studies. This is a specialized course for students who already have experience with clinical trials or have knowledge of clinical trial protocols and/or clinical trial reports.

Students who do not have experience with clinical trials or do not have knowledge of clinical trial protocols and/or clinical study reports are advised to follow the Medical Writing (Basic) course instead of this advanced course.

Lecturer

EMTEX is an independent and compact company that offers professional medical writing and related services all around the world to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions. We have a long track record in supporting our customers with dedicated services. Writing documents and presenting data in a clear and well-structured manner is our core competence.

The majority of EMTEX employees have a PhD in a scientific discipline and a passion for writing.

Topic

This course includes the following topics:

  • Drug development (key documents, guidelines, and regulations)
  • A day in the life of a medical writer
  • Plain Language Summary
  • Clinical summaries and clinical overview
  • Project management
  • Hands-on training

Objectives

The main objectives of this course are:

  • learn about the importance of a medical writer in drug development
  • understand the purpose, importance, and requirements of a Plain Language Summary
  • gain insight into advanced regulatory document types, including clinical summaries and the clinical overview
  • understand the project management around the writing process towards a finalized document

Assignment

During the lean writing course, we would like to put our recently learnt tips and tricks into practice with a real-world example. Therefore, we encourage you to send us your own (published or unpublished) work by Tuesday 24 March at the latest, preferably less than 1 page (eg, congress abstract, article conclusions, summary) that we can use to check with the group. We will pick 2 examples to go through together, but we will provide feedback (within two months after the course) to everyone who sent us some text. Please send your text to Thary Jacob: jacobt@emtexlifescience.com.

Dates and venue

To be announced

Registration

  • Follow this link for the registration and waiting list. Your registration will be confirmed by separate e-mail (outlook invite).
  • Cancellation of your registration can only be performed by sending an email to doctoralschools@ugent.be.
  • The no show policy applies.

Registration fee

Free of charge for Doctoral School members.

Number of participants

Maximum 20

Language

English

Evaluation method

100% attendance, active participation.

After successful participation, the Doctoral School Office will add this course to your curriculum of the Doctoral Training Programme in Oasis. Please note that this can take up to one to two months after completion of the course.

More information

Video of the previous edition