Research & Development

Level 1 -

Mastering Clinical Development of Biopharmaceuticals: Stages and Challenges

Presentation

Why participate?

Present the methodology and regulatory considerations required to successfully conduct a clinical trial.
Gain an overall understanding of the clinical development phases.

Training Context:

The clinical phases represent the final and longest stages in the development cycle of a biopharmaceutical. They are essential for evaluating the product’s safety and efficacy in humans. These stages are critical, as many projects are abandoned due to lack of efficacy, and it is often at this point that biotech companies seek to license their candidates to pharmaceutical groups.
Success depends on careful planning, robust trial design, and compliance with strict regulations set by agencies such as the FDA or EMA. Effective data management, clear communication with regulators, and adherence to Good Clinical Practices (GCP) are also crucial to securing final product approval.

Learning objectives

  • Understand the specific challenges of each phase of clinical development.
  • Become familiar with the regulatory requirements for clinical studies.
  • Learn the methodologies and approaches specific to each stage of clinical trials.
  • Grasp the fundamental principles of pharmacovigilance.
  • Anticipate the key requirements for preparing the Marketing Authorization Application dossier.

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

R&D professionals, project managers, business developers, engineers, clinicians.

Prerequisites

Good knowledge of biotechnology and/or therapeutic antibodies, or completion of the training courses “Development of a Biopharmaceutical Candidate” and “Pharmacological Studies in the Preclinical Development of Antibodies.”

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

Catalogue de formations-MabDesign-2023.pdf (11)

Christophe

CLEMENT

Directeur Business Development
ICTA
CEO
CLEMANN GROUP

Rating

Participant satisfaction rate :

4.3/5
(average over 54 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