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

Agenda Introduction and Problem Statement Methodology Results Discussion Conclusions

Special Characteristics of the pharmaceutical industry Taken from http://tuta.aalto.fi/en/midcom-serveattachmentguid-1e468c4f000159668c411e4a6e1d56a8c2c0eb70eb7/report_saari_012004.pdf

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

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 Taken from http://tuta.aalto.fi/en/midcom-serveattachmentguid-1e468c4f000159668c411e4a6e1d56a8c2c0eb70eb7/report_saari_012004.pdf

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. Taken from http://tuta.aalto.fi/en/midcom-serveattachmentguid-1e468c4f000159668c411e4a6e1d56a8c2c0eb70eb7/report_saari_012004.pdf

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

RMP – use 221AD301 as an example

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

Other CROs – Covance – PhIL Only https://pdfs.semanticscholar.org/f97a/7667bab74756fc9b26f594f0ae7f9a4c1bb2.pdf

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

Self-administered structured questionnaire Randomly selected professionals from pharma industries www.surveymonkey.com Other CROs – Covance – PhIL Only

Important risk encountered Critical Success factors Likert Scale 1-5 Demographics Risk Awareness Important risk encountered Critical Success factors Likert Scale 1-5 Other CROs – Covance – PhIL Only

Type of organization of the respondents N=20 questionnaires were sent 12 Questionnaires were completed Other CROs – Covance – PhIL Only Type of organization of the respondents

Professional backgrounds of the respondents Showing number of years of work experience of the respondents Professional backgrounds of the respondents Other CROs – Covance – PhIL Only

Ranking of risks based on their importance Other CROs – Covance – PhIL Only Ranking of risks based on their importance

Other CROs – Covance – PhIL Only Risk Awareness chart

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

Top three critical success factors : Leadership communication/ feedback Organization culture Other CROs – Covance – PhIL Only

Significance in the realm pharmaceutical industry Formulating road map Application in pharma space Other CROs – Covance – PhIL Only

Limited external validity Descriptive analysis Small sample size Limited external validity Other CROs – Covance – PhIL Only

Other CROs – Covance – PhIL Only