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CBI - 11th Annual Guidelines for Disseminating off-Label Information
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What activities did you attend at the event?
Agreement
By completing this form, you attest that you have participated in all selected activities in thier entirety.
Please rate the following:
The program was relevant to my work.
Content matched stated objectives.
Usefulness of handouts/AV.

Quality of facilities.

How well did the educational sessions give a balanced view of therapeutic options, including the use of generic names?
If you rated any of the above questions with 'fair,' 'poor,' 'disagree,' or 'strongly disagree' please explain:
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Objective 1: Discuss FDA initiatives surrounding off-label information.
The above objective will increase my professional competence.
The above objective will result in changes to performance in my professional practice.
The above objective will result in improved patient outcomes.
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
Objective 2: Explain how field-based personnel ensure compliance with the dissemination of scientific information.
The above objective will increase my professional competence.
The above objective will result in changes to performance in my professional practice.
The above objective will result in improved patient outcomes.
Objective 3: Discuss promotional review and monitoring of off-label prescribing.
The above objective will increase my professional competence.
The above objective will result in changes to performance in my professional practice.
The above objective will result in improved patient outcomes.
Describe how to adequately present risk information in advertisements and promotional pieces.
Identify top priority areas of the agency.
Analyze the latest untitled and warning letters from DDMAC.
Discuss trends in enforcement from regulatory bodies.
Discuss how the FDA's approach to online marketing may impact other areas of online communications.
Define the scope of activities expected of an MSL.
Discuss what falls within appropriate scientific exchange.
Identify the key components that should be included in an MSL Code of Conduct.
Describe how you can compliantly discuss products that have a high off-label use, without promoting the product's off-label indications.
Interpret and implement recent FDA guidances.
Identify the top considerations PRCs take into account during a review.
Discuss the short comings of the findings of the analyses that identified HCPs writing more off-label prescriptions.
Identify the significant changes to the FCA.
Discuss additional efforts to strengthen criminal enforcement of healthcare fraud.
Describe the details of the case of the Eli Lilly settlement.
Discuss the settlement agreement.
Discuss criteria used in recent enforcement actions.
List safeguards to help minimize risk.
Explore areas that should still be considered high risk for enforcement activity.
Objective 4: Analyze recent off-label cases.
The above objective will increase my professional competence.
The above objective will result in changes to performance in my professional practice.
The above objective will result in improved patient outcomes.
Please answer the following:

Do you believe this activity was appropriate for the scope of your professional activities?

Was the educational content scientifically sound?
Was the educational content free of commercial bias?
Was the mode of education effective to learning?
If faculty spoke about off-label or investigational uses of a product, was that information disclosed to you?
If you answered "No" to any of the above questions, please explain.
Were you solicited by sales personnel in an educational room while you attended this educational activity?
If you answered "Yes" to the above question, please explain.
How much did you learn as a result of this educational program?
What did you learn during this activity that you intend to integrate into your practice?

My professional competence would be improved if I had training on:

My professional performance would be improved if I had training on:

My patient outcomes would be improved if I had training on:

Are you interested in basic, intermediate or advanced level trainings?

What barriers might you have that would interfere with implementation of new information learned from this training?

How can this training be improved to better impact competence, performance and/or patient outcomes?

Additional comments:

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