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18-Jun-2020 17:39

The annual conference offers 14 Preconference workshops for those looking for in-depth education.

This workshop will educate the attendee in Good Clinical Practice (GCP) requirements and FDA audit expectations, in order to aid in preparation for an FDA GCP audit.

You may want a refresher on topics specific to medical device to include compliance with Good Clinical Practice (GCP) regulations, non-significant risk and significant risk studies, risk management, investigator initiated studies, monitoring process, human factors engineering integration and usability testing – you might want to attend this workshop.

Basic principles, as well as challenges, will be introduced through lecture, discussion and “hands-on” exercises.

But how can you share these facts in a clear and compelling manner? How should the abstract be prepared to communicate succinctly and clearly, and successfully be published?

How should a poster be formatted to visually grab the attention and interest of the viewer yet accurately convey results?

And finally, how do you effectively and confidently present your research findings orally in an easy to understand confident manner at a seminar or similar forum?

This workshop will answer these questions and furnish you with the tools, examples, and facts needed to accomplish these goals in a fun hands-on workshop format. This workshop, for coordinators, research nurses, clinical research managers, and program managers - with more than 5 years of experience, will demonstrate how to dissect a protocol to determine protocol requirements and to illuminate protocol needs.

Basic principles, as well as challenges, will be introduced through lecture, discussion and “hands-on” exercises.

But how can you share these facts in a clear and compelling manner? How should the abstract be prepared to communicate succinctly and clearly, and successfully be published?

How should a poster be formatted to visually grab the attention and interest of the viewer yet accurately convey results?

And finally, how do you effectively and confidently present your research findings orally in an easy to understand confident manner at a seminar or similar forum?

This workshop will answer these questions and furnish you with the tools, examples, and facts needed to accomplish these goals in a fun hands-on workshop format. This workshop, for coordinators, research nurses, clinical research managers, and program managers - with more than 5 years of experience, will demonstrate how to dissect a protocol to determine protocol requirements and to illuminate protocol needs.

This interactive workshop will provide the following: A brief introduction to the FDA; Overview of clinical research, including the Federal Regulations covering clinical research and clinical investigator obligations; Discussion on Trial Site Roles and Responsibilities; Explanation of the FDA’s Bioresearch Monitoring Program, focusing on the Clinical Investigator inspection; Insight on understanding the FDA GCP inspection: Who is the FDA auditor? Common FDA inspection findings at the clinical site audit; Specific examples of FDA-483 observations; FDA inspection strategy. This workshop will discuss the regulatory obligations of an IND/IDE sponsor-investigator. Arbit will describe the resources needed to support and the risks associated with conducting investigator-initiated clinical trials.