Solutions to the Challenges of Phase I and FIM Studies in Today’s World
| Date: | 29-Feb-12 to 29-Feb-12 |
| Location: | Online Webinar / California City / United States |
| Category: | Media, Advertising & PR IT |
This 90-minute webinar will help you identify the challenges in Phase I and FIM studies and present solutions on how to overcome these challenges.
As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. To not meet these challenges has consequences.
Areas Covered in the Seminar:
* What are the factors in choosing a defendable first dose of a NCE
* How to Set up of a site that is prepared for First-in-man studies
* How to develop an effective / efficient Phase I Program to be audit clear
* How to recruit Study Participants in this new age of Social Media
* How to not miss and accurately assess important Adverse Events
* How a well written Protocol prevents errors and warning letters
* How to not miss “safety Assessments” when you really do not know what to look for
As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. To not meet these challenges has consequences.
Areas Covered in the Seminar:
* What are the factors in choosing a defendable first dose of a NCE
* How to Set up of a site that is prepared for First-in-man studies
* How to develop an effective / efficient Phase I Program to be audit clear
* How to recruit Study Participants in this new age of Social Media
* How to not miss and accurately assess important Adverse Events
* How a well written Protocol prevents errors and warning letters
* How to not miss “safety Assessments” when you really do not know what to look for
Visitors
* Holders of the IND for new products
* Principal Investigators and sub investigators
* Clinical Research Scientists (PKs, Biostatisticians, ...)
* Safety Nurses
* Clinical Research Associates (CRAs) and Coordinators (CRCs)
* Recruiting staff
* QA / QC auditors and staff
* Study Monitors
* Clinical Research Data managers
* Principal Investigators and sub investigators
* Clinical Research Scientists (PKs, Biostatisticians, ...)
* Safety Nurses
* Clinical Research Associates (CRAs) and Coordinators (CRCs)
* Recruiting staff
* QA / QC auditors and staff
* Study Monitors
* Clinical Research Data managers
Exhibitors
At ComplianceOnline, we are focused on :
Enhancing global compliance, creating a world where quality and compliance professionals, regulators,and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
Enhancing global compliance, creating a world where quality and compliance professionals, regulators,and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
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