2010 Clinical Trials Training Course and 13th Annual Meeting

Jointly sponsored by
Indiana University School of Medicine

ASGCT Preliminary Program: CME Information

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General Meeting
Information CME
Information Program
Information Supporter & Exhibit
Information Registration

Continuing Medical Education

Clinical Trials Training Course
Annual Meeting

CLINICAL TRIALS TRAINING COURSE

ACCREDITATION STATEMENT

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Indiana University School of Medicine and the American Society of Gene & Cell Therapy. Indiana University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

DESIGNATION STATEMENT

Indiana University School of Medicine designates this educational activity for a maximum of 15 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

DISCLOSURE

In accordance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, educational programs sponsored by Indiana University School of Medicine (IUSM) must demonstrate balance, independence, objectivity, and scientific rigor. All faculty, authors, editors, and planning committee members participating in an IUSM-sponsored activity are required to disclose any relevant financial interest or other relationship with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services that are discussed in an educational activity.

NOTE

While it offers CME credits, this activity is not intended to provide extensive training or certification in the field.

EDUCATIONAL METHODS AND MATERIALS

Lectures, Case Presentations, Panel Discussions, Question and Answer Sessions, Audio/Video Presentations

EDUCATIONAL OBJECTIVES

At the conclusion of the activity, the participant should be able to:

Demonstrate familiarity with the federal regulations and guidelines for clinical gene transfer and cell therapy studies.
Identify and demonstrate Good Clinical Practice (GCP) as related to gene transfer and cell therapy.
Evaluate bioethics, research integrity and financial conflicts in clinical gene transfer and cell therapy studies.

EVALUATION METHOD

Evaluation by questionnaire will address program content, presentation, and possible bias.

NEEDS

Clinical gene transfer and cell therapy studies have become more and more complex due to ongoing developments in the field of gene and cell therapy itself, together with bioethics, research integrity, and financial conflicts, as well as federal mandates, regulations and guidelines. This meeting will provide an educational forum for scientists and clinicians to expand their knowledge about the Clinical Trial Process, including Preclinical Development, Clinical Trial Design, Approval Process, Trial Conduct, Compliance, Monitoring and Oversight, Bioethics, Research Integrity, Conflict of Interest, Clinical Trial Follow-up.

TARGET AUDIENCE

The target audience includes basic science and translational researchers, clinical investigators, physicians, postdoctoral fellows, graduate students, employees of federal government and regulatory agencies, and other healthcare professionals with an interest in all aspects of the Clinical Trials Development and Implementation Process.

13th ANNUAL MEETING

ACCREDITATION STATEMENT

NOTE: Sessions marked with an asterisk (*) are not part of the CME program.

DESIGNATION STATEMENT

Indiana University School of Medicine designates this educational activity for a maximum of 37.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

DISCLOSURE

NOTE

While it offers CME credits, this activity is not intended to provide extensive training or certification in the field.

EDUCATIONAL METHODS AND MATERIALS

Lectures, Case Presentations, Panel Discussions, Question and Answer Sessions, Audio/Video Presentations, Abstracts, Posters

EDUCATIONAL OBJECTIVES

At the conclusion of the activity, the participant should be able to:

Provide advice to patients who inquire about the potential of gene and cell therapy or the availability of open clinical trials, based on their exposure to the current clinical trials in gene and cell therapies.
Better instruct their students in medical school and other health venues using the state-of-the-art basic science and clinical trials data presented at the meeting.
Use the latest advances in gene and cell therapy to enhance their research mission, as physician scientists conducting basic and clinical research.
Demonstrate improved regulatory compliance in conducting gene and cell therapy clinical trials, through exposure to NIH and FDA faculty during the educational program.

EVALUATION METHOD

Evaluation by questionnaire will address program content, presentation, and possible bias.

NEEDS

Clinical gene transfer has become more and more complex due to ongoing developments in the fields of gene and cell therapy itself, together with bioethics, research integrity, and financial conflicts, as well as federal mandates, regulations and guidelines. Oligonucleotide Therapies, Novel Vector Development, Host-Vector Interactions and Vaccine Therapies will be discussed as well as many other scientific topics. This meeting will provide an educational forum for scientists and clinicians to expand their knowledge about the broad developments in these fields.

TARGET AUDIENCE

The target audience includes basic science and translational researchers, clinical investigators, physicians, postdoctoral fellows, graduate students, employees of federal government and regulatory agencies, and other healthcare professionals with an interest in the latest advancements in the field of gene and cell therapy.