Why participate?
Provide a step-by-step overview of the key elements required to complete the regulatory dossier.
Training Context:
Conducting a first-in-human clinical trial — and preparing the regulatory submission to authorize the entry of an Investigational Medicinal Product (IMP) into clinical development — is a complex and lengthy process. It often requires anticipating key issues well in advance.
The regulatory dossier includes several sections that must be considered as early as the initial phases of pharmaceutical development to optimize success.
This training is structured around that central thread: the regulatory dossier will be reviewed and discussed point by point, with a strong focus on pharmaceutical requirements and preclinical studies needed for each key section.
Interactive Teaching, Case Studies, Experience Sharing
Project Managers, Regulatory Affairs Managers, R&D, Preclinical or Clinical Development Teams, Chief Scientific Officers
Solid knowledge of biopharmaceutical development or prior completion of the course “From discovery to commercialization: developing a biopharmaceutical candidate”
Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.
Participant satisfaction rate :
Return rate of satisfaction questionnaires :
Registering online or by e-mail is a pre-registration. We will process your request within one week:
Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.
When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.
For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr