Bridging Preclinical and Clinical Development
Corso
Blended a Milano
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Descrizione
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Tipologia
Corso
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Livello
Livello intermedio
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Metodologia
Blended
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Lingue
Inglese
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Luogo
Milano
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Durata
4 Giorni
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Inizio
21/05/2024
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Tutoraggio personalizzato
Sì
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Lezioni virtuali
Sì
Reasons to attend
Bridging Preclinical to Clinical Development is a must-attend course for anyone who wants to advance their career in drug development.
This comprehensive course provides you with a deep understanding of the key concepts, tools, and techniques required to bridge preclinical research to clinical development. You'll learn about essential elements such as pre-clinical toxicology, CMC perspective for clinical development, manufacturing, clinical study design, and regulatory compliance, equipping you with the knowledge, skills, and confidence to succeed. Our expert trainers bring real-world experience to the table, offering practical examples and insights that will help you apply the knowledge gained in the course.
Sedi e date
Luogo
Inizio del corso
Inizio del corso
Profilo del corso
What CMC data do I need to have generated to allow my company to move forward into a Phase I study
Describe the elements needed to set the dose for a first in human study
Understand the content of an IMPD
Be able to identify what an appropriate design is for a First in
Human clinical study
Define regulatory aspects involved in first clinical studies
Understand the elements required for planning early stage clinical development
Everyone associated with First in Human studies and/or associated with preclinical Studies.
Project Managers & Clinical Research Associates (CRAs) working in First in Human Studies.
Managers involved with designing First in Human studies.
Decision makers to move from preclinical to clinical.
Investigational sites involved in phase I research.
Competent authorities and ECs involved in evaluating First in Human applications.
Academics wishing to create a company or go to industry could find this course useful. Otherwise, it’s possible that it won’t be relevant.
Professionals in these fields wishing to refresh their knowledge and skills.
Opinioni
Materie
- Scientific concepts
- Research Design
- Ethical & participants safety
- GCP
- Site management
- Product Development
Professori
Angeles Escarti-Nebot
Doctor
Dr Angeles Escarti-Nebot is a Principal Consultant and Head of the Nonclinical team at Scendea. Angeles has previously held positions in Parexel, PharmLex, nonclinical CROs and Academia. Her areas of expertise include Global Regulatory Strategy, Non-clinical and Quality development programs for biological and biotechnological products, cell and gene-based products as well as tissue engineered products for the US, EU and UK markets.
Programma
The safety of the subject in any clinical trial is of paramount consideration. First in Human (FIH) studies are special in this case as no data is available on how the investigational product will react in the human body. Preclinical data needs to be adequate to allow translation into a clinical study complying with all medical, scientific, ethical, and regulatory aspects.Historical cases have shown that bridging preclinical and clinical has not always been adequate. The gap needs to be understood first and then strategies need to be developed to enable a smooth translation of the preclinical data of “research in animals” to the clinical research with First in Human studies.This course highlights the various considerations to be considered while moving from preclinical research to clinical development in humans. It enables a bidirectional transfer of knowledge and research, making the transition into clinical research smooth and effective.The first part of the course will be spent describing the preclinical perspective (toxicology and manufacturing) including a workshop.The second part will focus on the clinical side of development, including First in Human study design, submission to authorities, the regulator’s perspective, and maintaining quality throughout the process. You will be able to put your newly gained knowledge immediately into practice as the trainers will guide you to take a new compound through the entire process. Read more about the drug development process here.
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Ti aiuterà a confrontare vari corsi e trovare l'offerta formativa più conveniente.
Bridging Preclinical and Clinical Development