Training: Development of the Investigator’s Brochure

About course

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:  Development of the Investigator’s Brochure