Research & Development

Level 1 -

Advancing your antibody into the clinic

Presentation

Why participate?

Identify the key studies required to advance an antibody into clinical phases while meeting regulatory expectations

Training Context:

Before obtaining authorization to test a therapeutic antibody in humans, it is essential to demonstrate product safety and control the manufacturing process to ensure quality and traceability.

Learning objectives

  • Understand the importance of determining the First-In-Human (FIH) dose
  • Grasp PK/PD principles and antibody-specific considerations
  • Know the minimum regulatory requirements to complete a Clinical Trial Application (CTA)
  • Understand analytical and CMC prerequisites

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 in biotechnology and therapeutic antibodies, or completion of the course “Fundamentals of therapeutic antibodies”

Duration

2 days, 14 hours

Price

1,500 € HT (Public)
1,200 € HT (Membre)
600 € HT (Académique)

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

Trainers

Jacques goutalier.pdf

Jacques

GOUTALIER

Independent Expert Consultant
Labatut René

René

Labatut

Independent Expert Consultant & CEO
R.PRONOEO

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