Medical Writing (Advanced)

Cluster

Research and Valorization

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

Dates and venue

19 November 2024 (9h30- 17h00)

Van der Valk hotel, Akkerhage, Ghent

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