Conference Description:

This course will start with an introduction to the different types/phases of clinical trials. The different types are intended to test for the safety and efficacy of the treatment in question. The key document in any clinical trial is the study Protocol. The general contents of this document are specified in the FDA Regulations - Code of Federal Regulations (CFR) section 21.

This document is key to everything that goes on during the trial. It is recommended that if you have anything to do with the trial you should review this document. During a clinical trial there can be a number of service groups, like laboratories, pharmacies, and various committees who are in a position to influence the results of the trial. These groups need to understand that they are also covered by the regulations and practices required for the clinical trial.

Another concept that is critical to the conduct of a clinical trial is Quality. Virtually everyone involved in the trial must understand their role in the quality of the results of the trial. This includes things like Quality Assurance, audits, procedures and policies and more.

It is also important to view the Project Management aspects of managing the trial and all of its components. This includes the concepts of Quality Management and Risk Management.

There will be a session that is an introduction to the FDA and current FDA Regulations. It is often important to understand the source of the regulations.

Finally, we will go through using Excel to develop cost estimates for the conduct of the various types of trials. This will include monthly and annual estimates for the various groups involved in the trials.

The Seminar:
This hands on seminar provides a practical approach what Clinical Trials are, what goes into their conduct, and how to manage them and how to estimate the costs associated with conducting a clinical trial.

Examining the different types of clinical trials and when they are used.
Identifying characteristics that distinguish various types of Clinical Trials.
Developing a rationale for scaling activities and effort based upon the type of trial.
Applying the various Regulatory Requirements.
Defining necessary operational and management activities.
Why should you attend:
Clinical Researchers
Lab Scientists
Nursing Staff
Information Technology (IT) personnel
Quality Assurance
Management and Laboratory System users
Hospital Management Staff
Suppliers of Computerized Systems for EMR/EHR
Regulators
Industries:
Pharmaceuticals
Medical Practitioners
Nursing Staff
Medical Device
Radiological Health
Blood Products
Food
Cosmetics
Tobacco
Academia

Read More: http://www.globalcompliancepanel.com/con trol/globalseminars/~product_id=901582SE MINAR?worldconferencecalendar-February-2 018-SEO