November Research Group provides a range of training options in support of your pharmacovigilance operations and systems.

Oracle® AERS End-User Training • A three-day course taught on your site on the basics of using Oracle for managing and reporting your adverse event, product complaint, medical error, and pregnancy/lactation exposure cases. The course includes modules on Case Management, Case Data Query, Reporting, and Data Consistency Checking. The cost of the course is based on standard November Research Group time and materials rates.

Oracle AERS Administrator Training • A two-day course taught on your site covering the fundamental aspects of administering Oracle AERS. The course includes modules on AERS Infrastructure, User Administration, Product Repository Maintenance, Basics of Workflow Configuration. The cost of the course is based on standard November Research Group time and materials rates.

Oracle AERS Advanced Configuration and Management • A two- to five-day course taught on your site exploring the configuration and management of Oracle AERS in exhaustive detail. The course can be tailored to your specific needs, and can include modules on Developing Custom Edit Checks, Adding Custom Fields, AERS Data Model Review for ad hoc access, Managing Synonym Lists with Oracle TMS, Establishing Clinical Data Reconciliation, and other topics. The cost of the course is based on standard November Research Group time and materials rates.

Oracle AERS PSUR Workshop • A two- to five-day interactive workshop held on your site focusing on the design, configuration, and production of the PSUR from Oracle AERS. During the course of the workshop the key data elements and processes required for producing the PSUR are reviewed, the various configuration options are analyzed, and the specific configuration options for your company are documented and deployed. The cost of the course is based on standard November Research Group time and materials rates.

PVU is a unique offering of focused, web-based training courses that are offered on-demand. The courses are delivered over the web by a live instructor and full training documentation is provided for each attendee. The fees are a standard $200/hour per student, with discounts available for group training. Any of the individual courses can be expanded or tailored to meet your specific needs, from customizing the course to expanding the content into a full consulting engagement. Current courses are listed below and new courses are added regularly:

Overview of Pharmacovigilance • A two-hour overview of the history and current practices. This course is suitable for an orientation for new hires in the drug safety or pharmacovigilance offices.

Pharmacovigilance Best Practices • A two-hour overview of best industry practices. The course is delivered for small, medium, and large companies.

Pharmacovigilance Technology Review • A two-hour review of the major commercial systems available for pharmacovigilance and safety reporting.

Selecting a Pharmacovigilance System • A two-hour overview of the process of evaluating the commercial systems for pharmacovigilance. The course provides a high-level methodology to manage the entire process of developing requirements, evaluating the software and the vendors, making the selection, then initiating the implementation.

Oracle AERS - Creating Cases • A one-hour review of the process of creating new cases in Oracle AERS, including a review of the Case ID Generation and Duplicate Check functions.

Oracle AERS - Managing Cases • A two-hour review of case management features in Oracle AERS, including case workflow basics.

Oracle AERS - Discrepancy Management • A two-hour review of data consistency checking and discrepancy management.

Oracle AERS - Basic Case Query • A one-hour review of the basics of using the Query Module to identify cases of interest.

Oracle AERS - Advanced Query Techniques • A two-hour review of advanced query techniques in Oracle AERS, including use of dictionary switches, multiple component queries, and working with query conditions.

Oracle AERS - Running Reports • A one-hour overview of the basics of running reports.

Oracle AERS - Submission Management • A one-hour review of the submission management process, including running draft versus submission reports, and tracking initial and follow-up reports.

Oracle AERS - User Administration • A two-hour review of the features of user administration, including a review of the AERS security model and the process for creating and managing users.

Any and all of the training materials and courses above can be combined into a full training curriculum for your department's needs. November Research Group can develop train-the-trainer materials, computer-based training materials or focused training courses tailored for your specific needs.