Planning for a Successful Safety Data Conversion
- PDF / 635,120 Bytes
- 9 Pages / 504 x 719.759 pts Page_size
- 4 Downloads / 186 Views
0092-8615/200 1 Copyright 0 2001 Drug Information Association Inc.
PLANNING FOR A SUCCESSFUL SAFETY DATA CONVERSION JANETSTEINER,RN, BSN, MS Director, Safety Strategy
CHRISTINA CAUTERUCCI Director, Safety Operations
YOUNGSHON Drug Safety US Manager AstraZeneca LP (formerly Astra Pharmaceuticals), Wayne, Pennsylvania
ALANR. MUIRHEAD,PHD Senior Validation Consultant, Taratec Development Corporation, Bridgewater, New Jersey
Proper planning is critical when converting or migrating adverse event databases, especially when products are shifted between different companies. This article, based upon experience gained in several recent conversions, presents key elements that must be addressed when preparing for safety database conversions. Initial planning should include a careful definition ofproject scope, based on both business process reviews and technical analysis of the database systems. Throughout the project, sufficient resources, drawn from all groups that are impacted by the conversion, must be committed to the conversion effort to be sure all issues are identified and resolved. Communications must be open and frequent, not only among the conversion team but also with other affected groups. Contingency plans must be prepared in case of delays or problems in the conversion, and provision must be made for follow-up support after the conversion. Key Words: Adverse events; Data conversion; Validation; Planning; Data migration
INTRODUCTION
tained in order to keep the business successful. A significant example of such a process is the adverse event reporting capability. Even as organizations are restructured, they must continue to meet international regulatory requirements for reporting adverse events that occur in association with their products. To do this, organizations must reconcile, merge, or convert disparate drug safety databases into a single database. Over the past several years the Drug Safety Department of AstraZeneca LP has converted adverse event data from three different companies and migrated the data into
THE END OF THE 20th century has seen major structural changes in the pharmaceutical industry, as corporations are merged, divisions are spun off, product lines are sold or exchanged, and new companies are created. While corporate management focuses on potential strategic impact, at an operational level fundamental processes must be main-
Reprint address: Janet Steiner, FW,BSN, MS, Astra~ p 800 , Concord Pike, wilmington, DE 19850.
zenecaph-aceuticals
61
Downloaded from dij.sagepub.com by guest on August 18, 2015
62
Janet Steiner. Christina Cauterucci, Young Shon, and Alan R. Muirhead
SafeTNet, its in-house adverse event system. Based upon experience gained in these conversions, key elements have been identified that should be included in planning for a safety database conversion. Careful planning greatly influences how well a data conversion will go. Successful conversions require: Careful definition of the project scope, including analysis of costs, review of the business processes, and
Data Loading...
