Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated
Date & Time: Tuesday, March 6, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Charles H Pierce
Price : $245.00
(for one participant)
Charles H Pierce Consultant, Clinical Research / Drug-Device Development,
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 that no longer: l
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.
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies. ...more
Areas Covered in the Session: l
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
Click here to register for this webinar Who Will Benefit: l
Principal Investigators and sub investigators
Clinical Research Scientists Research Managers Safety Nurses
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Clinical Research Associates (CRAs) and Coordinators (CRCs) Recruiting Staff QA / QC auditors and staff Study Monitors Clinical Research Data managers
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Published on Feb 8, 2012
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 d...