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CBI - 14th Annual Forum on Off-Label Guidelines
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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.
PHARMACISTS AND PHARMACY TECHNICIANS ONLY -- Please provide the following:
NABP eProfile ID (ePID):
Date of Birth (MM/DD) - Example September 24 would be 0924:
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. 
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 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 in detail (e.g. session title, speaker name, situtation):
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:
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:
Having completed the activity, please rate your ability to meet each of the following objectives:
Discuss  current trends in off-label cases and litigation.
Explain what whistle blowers are saying about their company's conduct.
List the current trends in the type of off-label allegations cited by OPDP.
Discuss the evolving nature of misbranding off-label allegations.
Discuss the future of off-label in the face of the new FDA guidance and Federal Review Notice.

Define off-label promotion.

Discuss recent and notable OPDP letters including activity related to in-person promotion.

Discuss notable settlements from 2011 regarding off-label promotion.
Discuss recent enforcement actions against individuals and the underlying alleged activity.
Explain which actions have been succesful and which have failed.
Discuss key takeaways to improve internal compliance activities.
Discuss recommendation from the government on how to monitor and prevent off-label promotion.
Identify top priorities for enforcement.
Discuss and evaluate False Claim Act Statutes across federal government and individual states.
Explain how to effectively track communications between field-based teams and physicians.
Discuss the positive impact of a concrete, internal set of compliance regulations.
Explain ways to prevent the relay of off-label information from sales to prescribers.

List tips for creation of an internal social media policy that addresses appropriate and inappropriate communication.

Discuss elements of appropriate and inappropriate scientific exchange.
Discuss these elements to the FDA's recent request for public response answering the thirteen questions related to scientific exchange.
Define the distinction between scientific exchange and promotion.

Discuss the difference between communications concerning the use of unapproved products versus new uses of approved products.

Discuss recent industry guidance regarding target lists, sales goals and compensation plans.
Discuss red flags in compensation plans, target lists and sales goals that should be monitored.
Discuss better industry practices to mitigate risk of off-label promotions related to target lists, sales and compensation plans.
Discuss appropriate distinctions between promotion and scientific exchange to ensure understanding of a compliant internal and external communication process.
Discuss the benefits and potential pitfalls of joint training sessions with MSLs and sales representatives that address the purpose of each funtion.
Explain how to manage communication between MSL team and their commercial colleagues to minimize risk and maximize value to the organization.

Discuss Learnings from day 1.

Review compliant MSL interactions with decision makers, prescribers, payers and patients.
Define best practices for interactions and appropriate communications between MSL and sales departments.
Discuss the state of MSL position if the FDA provides guidance clearly permitting specific off-label activities.
Describe the value of MSLs bring to ensuring full and complete information available to decision makers.

Discuss how the evolving needs of an organization impact system selection.

Disucss the impact of new technologies such as iPads on customer engagement.

Explain which features are crucial for an effective and compliant system.
Evaluate potential effective training techniques Benchmark current SOPs against industry peers.
Explain how to improve compliance practices regularly without creating confusion or completely changing processes.

Discuss how an informed promotional review board is the best protection.

Discuss high risk areas in internal and external communications.
Explain how to target SOPs to specific risk areas and functions within your organization.

Explain how to create and implement effective SOPs and best practices for effectively rolling them out to your organization.

Discuss the role of compliance on the committee and how wide spread is their acceptance.
Explain how can compliance add value on the committee.
Discuss real life examples of succesful communications.
Discuss the impact of FDA and DOJ guidance and regulations.
Discuss compliant methods to deliver the proper treatment options to prescribers and patients.
Discuss effective training activities.
Discuss the benefits of up-to-date compliance training, especially in a changing regulatory enviroment.
Discuss the benefits of cross-company training on what is and is not off-label communication.
Objective 1: Discuss FDA's New Guidance on responding to unsolicited requestions for off-label 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.
Objective 2: Discuss risks associated with Responsible Corporate Officer Doctrine.
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.
Objective 3: Discuss the changing role of MSL's in the current compliance environment..
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.
Objective 4: List different types of misbranding violations and discuss notable settlements.
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.
Please answer the following:
Do you believe this activity was appropriate for the scope of your professional activities?
Was the educational content scientifically sound?
If faculty spoke about off-label or investigational uses of a product, was that information disclosed to you?
Was the mode of education effective to learning?
If you answered "No" to any of the above questions, please explain.
Did you perceive any product/service/company/commercial bias in any educational session you attended or materials you received?
If you answered "Yes" to the above question, please detail the situation below (e.g. session title, speaker name):
Were you solicited by sales personnel in an educational room (other areas do not matter) while you attended this educational activity?
If you answered "Yes" to the above question, please explain in detail (e.g. who, when, where):
How much did you learn as a result of this education program?
What specifically 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/client problems or patient/client challenges do you feel you are not able to address appropriately or to your satisfaction?
What problems are your patients/clients 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 (the overall meeting) be improved to better impact competence, performance and/or patient/client outcomes?

Additional comments:

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