Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated – Webinar By GlobalCompliancePanel

Description

Overview: This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies. 

It is in Phase I where the eventual safe clinical dosage range is defined as well as how the body handles the drug in the normal situation, When there is compromised organ of elimination function, in the fasted and fed states as well as carefully looking at the possibility of major drug interactions. As expected the safety of the drug in human subjects is the backbone of Phase I investigations.

The most critical study is the FiM where it is imperative that the dosage started with has been carefully selected so that toxicity is nil or absent. Among the many challenges we face is thatno longer:

• Is the First-in-Man study only done on normal healthy volunteers. 


• Are protocols fixed lines in the sand that are not changeable until the study ends. 


• Is the New Chemical Entity (NCE) a simple chemical with predictable effects. 


• Do we see Phase I studies conducted only in confined Clinical Pharmacology Units.

All of these challenges make recruiting more challenging and Monitoring equally so. The answer is to identify the challenges and keep up with the changing environment in the development of these NCE’s in ever more complex and serious diseases.

Why you should attend: The lines of distinction between the classical phases in the drug development are becoming more and more blurred, and the challenges facing the Sponsor, the Principal Investigator, and the sites are becoming increasingly important. These challenges must be known and appreciated

Areas Covered In the Session:

• What is the roll of the Investigators Brochure in the FiM process?


• What do you expect to learn from the FiM study?


• What are the factors in choosing the first does of a NCE


• The challenge of developing an effective / efficient Phase I Program 


• How to recruit Study Participants in this new age of Social Media


• The importance of accurately assessing and reporting Adverse Events


• The importance of Protocol knowledge in preventing errors


• How to not miss "safety Assessments" when you do not know what to look for


• The Setting up of a site that is prepared for First-in-man studies

Who will benefit:

• Principal Investigators and sub investigators


• Clinical Research Scientists


• Research Managers


• Safety Nurses


• Clinical Research Associates (CRAs) and Coordinators (CRCs)


• Recruiting Staff


• QA / QC auditors and staff


• Study Monitors


• Clinical Research Data managers

Organized by

Country: United States of America.Event Categories: Webinar.Industry: Beauty,Health Care and Legal.