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Overview

In July 2017, the EMA released a revised 'Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products’. This workshop aims to explain the guidance, with involvement of assessors from regulatory agencies.

The course will begin with presentations on the nonclinical issues and discussions on Dose Selection. The second part will focus on design element of the FIH and Early Clinical Trials and clinical monitoring. The speakers have been members of the drafting group involved in the finalisation of the guideline.

Who should attend?

This course is designed for non-clinical and clinical experts in pharmaceutical industry involved in drug discovery and early clinical development; CROs, consultants, employees of FIH clinical trial units, and regulatory assessors involved in clinical trial approval.

Learning objectives

At the conclusion of this short course, attendees will be able to:
• Recognise the revisions of the Guideline in relation to the previous version from 2007.
• Identify the regulatory issues for designing new First-in-Human and early clinical trial protocols