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IIR - The Safety Continuum in the Medical Product Life Cycle
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Agreement
By completing this form, you attest that you have attended the activity in its 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:

Objective 1: Review current pre- and post-marketing pharmaceutical safety reporting requirements in the United States and European Union.
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 the latest pharmacovigilance standards in Japan and Asia/Pacific Rim
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: Describe the FDA medical device 510(k) approval process and implications for patient safety
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: Explain the integration of preclinical animal and human clinical pharmacology data into premarketng development, safety assessment and risk management.
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 5: Compare regulatory agency approaches to clinical trial safety and post-marketing pharmacovigilance inspections in the US, Europe and Japan.
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 6: Recognize the relative contributions of data quality, data mining and periodic safety update reports to signal detection and evaluation.
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 7: Discuss optimal Quality Assurance in medical product safety across the pre-and post-marketing continuum.
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 8: Define current risk management approaches in a global medical product safety 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 9: Summarize ongoing assessment of a medical product's benefit/risk profile throughout its life cycle.
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 practice?
Was the educational content scientifically sound?
Was the educational content free from commercial bias?
Was the mode of education effective for 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:
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 from this training?
How could this training be improved to impact your competence or performance in practice?
Additional comments regarding the speaker or session:
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