Understanding Case Processing and Fda Submission

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UNDERSTANDING CASE PROCESSING AND FDA SUBMISSION

INTRODUCTION
There is a major turnaround time for the hiring physicians and support staff. Physicians tend to terminate their position after three years, so that area is always understaffed. The support staff is frequently hiring new nurses, but it takes 1-2 months to fully train them. The support staff has a training center for all new hires. The new hires are trained in customer service and medical technology such as coding and triage. Since the senior level nurses are training the new hires, the caseload is increasing considerably. Without proper training, some support staff members are submitting incorrect data.

The FDA requires that all cases be submitted within a 5-day period. The support staff will need to report all cases to affiliate countries within the 5-day period to meet their regulatory requirements. If timeline requirements are not met, this could result in a fine. There are usually seven physicians that review cases from sixty-five nurses. The training period is very intense. Some physicians work as contractors which means they could leave within six months. The physicians’ area is always understaffed. Lawler has also to implement a new database (AEGIS) to acquire new products and have a stronger gateway to the FDA’s database. This new process in still in the beginning stages, so training will be required for all employees. My current position is being a liaison between the physicians and support staff. I am responsible for submitting various reports to the FDA and our regulatory department. I am also required to perform a quality check on several documents prior to submission. My job is complete once I receive confirmation from a FDA agent and documentation is sent via email or fax. In Table 1, the OCI shows the power culture in the Aggressive/Defensive cultural target. This culture has members to believe they will be rewarded for taking charge and controlling subordinates. Power-oriented organizations are often deceived the rebellious workers due to the strict demands and controlling conditions. Unfortunately, this has not worked in this department considering the numerous employees that have left the company.

Table 1
| OCI STYLE| RAW SCORE| PERCENTILE SCORE| GAP|
CONSTRUCTIVE| AchievementSelf-Actualizing| 72%82%| 54%79%| 20%3%| | Humanistic-EncouragingAffiliative| 85%71%| 74%72%| 11%+1%| | | | | |
PASSIVEDEFENSIVE| ApprovalConventionalDependentAvoidance| 27%18%24%27%| 48%42%13%33%| +21%+24%11%+6%| | | | | |
AGGRESSIVEDEFENSIVE| OppositionalPowerCompetitivePerfectionistic| 45%30%42%25%| 30%88%46%48%| 15%+58%+4%+23%| | | | | |

PROBLEM STATEMENT
Reviewing the current workflow process for the medical inquiry fulfillment and identifying areas for improvement between the physicians and support staff. The physicians are constantly overworked due to the change in caseload and limited manpower. The support staff has an abundance of new hires with little training. The main concern is organization and communication between the two areas. In the past months, the areas work under a 15-day timeline reporting requirement to the FDA. In the recent weeks, the timeline has increased to 5-day reporting requirement to the FDA. Over the past years, the company has been cited seven times for late case reporting and incorrect data submitted. A new database has been created to make Lawler compatible with other pharmaceutical companies and the FDA. With the new process change, no one has been completely trained on the new database. How will the department process the caseload using the new timeline to report to the FDA? Would technology improvements be needed to process the cases in a timely manner? LITERATURE REVIEW

According to The Federal Trade Commission, physicians obtain drug information from reports on clinical trials published in medical journals and distributed by drug...
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