1. Critical Risk Assessment and Management Practices in Pharmaceutical Industry Abida Zameer Harrisburg University GRAD 699 PGMT

2. Agenda Introduction and Problem Statement Methodology Results
Discussion
Conclusions

3. Special Characteristics of the pharmaceutical industry
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4. Open forum to provide information on file review “how to” and to discuss any issues your teams are encountering in the file review/TMF oversight process
Each functional group has a prescribed process and we are beginning to align some of the processes but there are still significant differences among the functional teams that can lead to overall confusion. For instance – what does a completeness review mean for each functional team?
We would like to come to a common understanding of what Document Review and Completeness review mean and what certification means at the end of a trial
Most of us are familiar with all the tools available but we will take some time to go over them one more time and be sure everyone understands what they are and how to use them
We recently discussed, at a Core Team Meeting, standardizing how feedback is delivered to Quintiles – both in physical format and in communication process - so I want to check in and see if your teams have been able to adapt to what we discussed and see if we are making the transition and what, if any, issues you have encountered
Recent review has opened the door for a discussion about whether functional teams are following up on action items/feedback and verifying that the items have actually been resolved. So, we will discuss that process and how it should work and how we can improve on action item resolution. Because identifying a problem is only the first step, resolving it is the critical step. If we do not resolve, then we have created an even bigger issue in knowing a problem exists and not doing anything about it.
Then, once a file review is complete, what is done with the output. Changes continue to be made in how feedback/results of review and certification are filed so we want to make sure expectations are clear and the process well-defined.
And of course, finally, how do we track compliance to the entire file review process? How do we report results and make sure the process is being followed? Chris Port is here this week to walk us through reporting/metrics as well as how samples are generated for document review and show some possible way to create tools that could aid in completeness review.
Any questions/comments before we get started.
PhRMA profile 2014

5. Special characteristics of projects and project management in Pharmaceutical Industry
Here is a slightly more granular 10,000 ft view of the details within each broad area.
Any comments/questions?
OK – let’s start with a review of the tools available to aid in managing TMF quality
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6. Most basic tool is the Partnership SharePoint site – lots of information contained on this site – go to the site and surf.
TMF Plan – should contain basic information about the maintenance of a TMF
TOC – customized for a trial at the start of the trial
QC workbooks-Chris will be discussing the process for the generation of these workbooks later on today
Feedback template – recommended minimal information and format for that information in order to standardize communication with vendors and facilitate turnaround of feedback.
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7. Not a management gimmick Helps to avoid big disaster
Ensures the successful completion of project
Helps to explore new opportunities
RMP – use 221AD301 as an example

8. RMP – use 221AD301 as an example

9. What is Risk? Undesirable Future Effect What could go wrong?
Other CROs – Covance – PhIL Only

10. Other CROs – Covance – PhIL Only

11. Proper implementation of principles of project risk management is well known to minimize the impact of threats to any project. However, the determination of critical success factors which threat the success of pharmaceutical projects at baseline are usually uncertain.
Good leadership and clear communication and organization culture are the most important critical success factors for the implementation of risk assessment and management practices in the pharmaceutical industry.
Regulatory risk is the most important risk in the pharmaceutical industry.
Other CROs – Covance – PhIL Only

12. Self-administered structured questionnaire
Randomly selected professionals from pharma industries
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13. Important risk encountered Critical Success factors Likert Scale 1-5
Demographics
Risk Awareness
Important risk encountered
Critical Success factors
Likert Scale 1-5
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14. Type of organization of the respondents
N=20 questionnaires were sent
12 Questionnaires were completed
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Type of organization of the respondents

15. Professional backgrounds of the respondents
Showing number of years of work experience of the respondents
Professional backgrounds of the respondents
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16. Ranking of risks based on their importance
Other CROs – Covance – PhIL Only
Ranking of risks based on their importance

17. Other CROs – Covance – PhIL Only
Risk Awareness chart

18. Regulatory risk is the most important risk
In similar studies 67% of the respondents marked as number one risk in the pharmaceutical companies
Awareness of risk management processes is closely linked to the critical success factors of “ effective use of methods and tools” and “availability of specialist risk and management consultants”
Other CROs – Covance – PhIL Only

19. Top three critical success factors : Leadership
communication/ feedback
Organization culture
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20. Significance in the realm pharmaceutical industry
Formulating road map
Application in pharma space
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21. Limited external validity
Descriptive analysis
Small sample size
Limited external validity
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22. Other CROs – Covance – PhIL Only