Logo1
CBI - 12th Annual Guidelines for Disseminating Off-Label Information Conference
Mr pencil

How would you like your name to appear on your certificate?



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. 
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 recent regulatory and enforcement activities surrounding off-label promotion.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
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:
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: Review strategies and tactics that will ensure compliance during the dissemination of product information.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Having completed the activity, please rate your ability to meet each of the following objectives:
Determine what interactions have the potential for increased risk of off-label promotion in the field.
Discuss what trends may be seen in recent CIAs related to off-label promotion.
Develop processes, procedures and documentation practices that should be put in place to monitor for off-label promotion.
Discuss key regulatory and compliance considerations to take into account when using social media tools, with a focus on how to put policies and processes in place to mitigate the risks of off-label promotion.
Identify trends in recent off-label promotion allegations, investigations, enforcement activities and settlements by the Department of Justice and FDA.
Discuss  current and former prosecutors as noncompliant behaviors found within off-label promotion investigations and settlements.
Discuss how an off-label marketing case is built.
Explain how a bio/pharmaceutical company’s work with a medical marketing/communication firm sets the groundwork for RICO conspiracy charges if they are found to be promoting a product off-label.
Discuss how medical affairs/medical information/medical science liaison (MSL) teams operate when under an OIG Corporate Integrity Agreement (CIA).
Discuss monitoring practices to ensure compliance out in the field related to the dissemination of scientific information.
Discuss MSL core activities, definitions and high risk areas for non-compliance, as well as how to minimize risk.
Discuss how reimbursement data can be linked with patient longitudinal data to identify off-label prescribing patterns and identify fraud and abuse by physicians and patients.
Discuss top considerations of promotional review committees to ensure appropriate product promotion and communication.
List types of information and literature that may be distributed at a medical meeting.
Identify what may be done if off-label promotion is suspected.
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?

What questions have arisen in your practice for which you need answers/strategies that you can implement?

What patient problems or patient challenges do you feel you are not able to address appropriately or to your satisfaction?
What problems are your patients communicating to you that need attention or follow up?

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:

Mr question