Development of the Investigator’s Brochure

Categories: Medical writing
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About course

This training is designed to help medical writing professionals effectively write Investigator Brochures for investigational medicinal products.

What will you learn?

  • This training is designed to help medical writing professionals effectively write Investigator Brochures for investigational medicinal products. The learning objectives of this training are:
  • 1) define an Investigator’s Brochure, its purpose and when it is needed,
  • 2) know the key sections of an Investigator’s Brochure and the elements of information to be addressed in each section, per current regulations and guidelines,
  • 3) know your source materials to populate each of the key sections, and
  • 4) be prepared for challenges and be aware of some general tips and tricks for writing an Investigator’s Brochure.

Course content

Development of the Investigator’s Brochure
The learning objectives of this training are: 1) define an Investigator’s Brochure, its purpose and when it is needed, 2) know the key sections of an Investigator’s Brochure and the elements of information to be addressed in each section, per current regulations and guidelines, 3) know your source materials to populate each of the key sections, and 4) be prepared for challenges and be aware of some general tips and tricks for writing an Investigator’s Brochure. "

  • Introduction: Development of the Investigator’s Brochure
    01:55
  • Overview and basics
    03:38
  • Regulations and guidelines
    01:13
  • Overall structure and content
    17:25
  • Source material and relation with other documents
    03:26
  • Recommendations for writing
    05:06
  • Congratulations
    00:19

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A course by

Thary Jacob
Thary Jacob

Currently, I’m a motivated specialist medial writer at Emtex Life Science.

I studied biomedical sciences at the University of Ghent, mastered in immunology and did a PhD at the laboratory for veterinary animal sciences in Merelbeke on alphaherpesviral spread, triggered by interesting research along my path.

While I enjoyed doing this, I wanted to be closer to patients in my career path, which is why I chose to go to the industry. I wanted to be near the end, the patient, the finalized stage - to contribute to telling the story. Medical writer seemed the perfect job for me, and I haven’t had any regrets during the past 8 years that I’m a medical writer at Emtex.

Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.

With over 20 years of experience in the field, we guarantee the best possible medical writing and related services.