Regulations & quality and bioproduction

Level 1 -

Regulatory prerequisites for entering clinical development

Presentation

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.

Learning objectives

  • Understand the minimum regulatory requirements for completing a Clinical Trial Application (CTA)
  • Define the appropriate actions to move a project into the clinical phase
  • Learn about available tools to optimize biopharmaceutical development
  • Develop a strategic approach to conducting regulatory non-clinical studies

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Project Managers, Regulatory Affairs Managers, R&D, Preclinical or Clinical Development Teams, Chief Scientific Officers

Prerequisites

Solid knowledge of biopharmaceutical development or prior completion of the course “From discovery to commercialization: developing a biopharmaceutical candidate”

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

Trainers

Loget Olivier

Olivier

LOGET

President & CEO
CapEval Pharma

Rating

Participant satisfaction rate :

4.4/5
(average over 11 people).

Return rate of satisfaction questionnaires :

100%

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

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