Systems and methods for managing regulatory information

• US 8,612,249 B2
• Filed: 12/20/2011
• Issued: 12/17/2013
• Est. Priority Date: 02/15/2006
• Status: Active Grant

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: Lawton, Alison, Carle, Rachel, Mehta, Monica, Durham, Mary, Kiely, James Earl, Puig, David J., Granfield, Richard J.
• Primary Examiner(s): Pauls, John
• Assistant Examiner(s): NGUYEN, TRANG T
• Application Number:
  US13/331,496
• Publication Number:
  US 20120158604A1
• Time in Patent Office: 728 Days
• Field of Search: 705/2, 705/3
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/109 Time management, e.g. calendars, reminders, meetings or time accounting
• CPC Class Codes: G06Q 30/018 Certifying business or products
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Systems, methods, and articles of manufacture are provided for managing regulatory data pertaining to a healthcare product. For example, the system may include a network interface for receiving, from a client terminal, a request for regulatory data related to regulatory activity about a product as it pertains to a regulatory authority. The system also includes interconnected information stores for storing regulatory data associated with the product, where the information stores may include: contact records associated with respective contacts with the regulatory authority; commitment records associated with respective commitments made to the regulatory authority; and product information records associated with respective documents associated with the product. The system also includes a processing module for identifying, in response to the received request, each contact record, commitment record, product information record, and central files record associated with the product related to the received request.

Claims

1. A computer-implemented system utilized by a healthcare entity for managing and accessing a plurality of regulatory data records related to healthcare, the system comprising:

a memory storage configured to store the plurality of regulatory data records;

an interface module configured to receive information related to a communication of the healthcare entity with a regulatory healthcare authority; and

one or more computer processing modules utilized by the healthcare entity and configured to;

generate a contact record for storing the information related to the communication, wherein the communication of the healthcare entity with the regulatory healthcare authority is related to obtaining approval from the healthcare authority for a healthcare product;

perform a determination as to whether the communication results in a commitment, wherein the commitment includes an obligation made by the healthcare entity during the communication to perform a task required by the regulatory healthcare authority in order to obtain the approval for the healthcare product; and

based on the determination, create a link between the contact record and a commitment record which records the commitment, wherein due to the link, a query about one of the contact record and the commitment record results in presenting both the contact record and the commitment record.

2. The computer-implemented system of claim 1, wherein the commitment record reflects commitments made to the regulatory healthcare authority.

3. The computer-implemented system of claim 1, wherein the commitment includes an agreement to perform a product testing or an obligation to perform a study.

4. The computer-implemented system of claim 1, wherein the contact record stores one or more of a date of the communication, a communication medium, an origin of the communication, a product corresponding to the communication, a manufacturing facility corresponding to the communication, a regulation corresponding to the communication, a reason for the communication;

a region or country discussed during the communication;

a summary of a discussion in the communication, information identifying a person involved in the communication, and a digital representation of a signature of a person responsible for signing the contact record.

5. The computer-implemented system of claim 1, further comprising a database module for storing a plurality of links among the plurality of regulatory data records, wherein each of the plurality of links implies a relationship among a pair of the plurality of regulatory data records.

6. The computer-implemented system of claim 1, wherein the one or more computer processing modules are further configured to receive a request from a user to access one of the contact record or the commitment record, and, based on the link, present to the user both the contact record and the commitment record.

7. The computer-implemented system of claim 1, wherein the healthcare entity is a pharmaceutical company or a biotechnological company.

8. The computer-implemented system of claim 1, wherein the regulatory authority is responsible for approving that the healthcare entity manufacture, use, sell, promote, import, export, or store the healthcare product, and wherein the communication is related to obtaining the approval.

9. The computer-implemented system of claim 1, wherein the task includes performing a testing of the healthcare product or a healthcare study by the healthcare entity.

10. The computer-implemented system of claim 1, wherein the one or more computer processing modules further generate a data management display section including a plurality of parameter data fields configured to receive information associated with the contact record, wherein the parameter data fields include a commitment generation field indicating that the commitment was generated.

11. The computer-implemented system of claim 10, wherein performing the determination includes receiving an input through the commitment generation field.

12. The computer-implemented system of claim 10, wherein the parameter data fields further include one or more of a contact date field associated with a date of the communication, an agency field associated with the regulatory healthcare authority, a contact personnel field associated with a personnel of the healthcare entity involved in the communication, a communication medium field associated with a medium of the communication, and a subject field associated with a subject of the communication.

13. A computer-implemented system utilized by a healthcare entity for managing and accessing a plurality of regulatory data records related to healthcare and stored by the healthcare entity, the system comprising:

a memory storage configured to store the plurality of regulatory data records related to healthcare;

one or more computer processing modules utilized by the healthcare entity and configured to generate an interlink between two regulatory data records of the plurality of regulatory data records, wherein the two regulatory data records include a contact report record reflecting a communication between the healthcare entity and a regulatory healthcare authority and a commitment record reflecting a commitment made by the healthcare entity to the regulatory healthcare authority, wherein the communication is related to obtaining approval from the healthcare authority for a healthcare product, the commitment includes an obligation made by the healthcare entity during the communication to perform a task required by the regulatory healthcare authority in order to obtain the approval for the healthcare product, and the interlink is based on a common attribute between the two regulatory data records; and

an interface module configured to receive a query about a first of the two regulatory data records and accordingly present the first of the two regulatory data records and further to present the second of the two regulatory data records due to the interlink.

14. The computer-implemented system of claim 13, wherein the one or more computer processing modules are further configured to receive update information from a user related to the first of the two regulatory data records, and accordingly to create the second of the two regulatory data records or issuing a prompt to update the second of the two regulatory data records, wherein the received update information results from the communication between the healthcare entity and the regulatory healthcare authority, and wherein creating or updating the second of the two regulatory data records includes creating or updating the commitment record.

15. The computer-implemented system of claim 13, wherein the first or the second of the two regulatory data records is related to plans for filing the healthcare product.

16. The computer-implemented system of claim 13, further comprising a security module configured to assign a security profile to a user and for presenting to the user a subset of the plurality of regulatory data records, wherein the subset is consistent with the security profile of the user.

17. The computer-implemented system of claim 13, wherein the one or more computer processing modules are also configured to capture an audit trail of modifications to the plurality of regulatory data records.

18. A computer-implemented method performed by a healthcare entity for managing and accessing a plurality of regulatory data records related to healthcare, the method comprising:

storing, via a memory storage, the plurality of regulatory data records;

receiving, via an interface module, information related to a communication of the healthcare entity with a regulatory healthcare authority;

generating, via one or more computer processing modules utilized by the healthcare entity, a contact record for storing the information related to the communication, wherein the communication of the healthcare entity with the regulatory healthcare authority is related to obtaining approval from the healthcare authority for a healthcare product;

performing, via the one or more computer processing modules, a determination as to whether the communication results in a commitment, wherein the commitment includes an obligation made by the healthcare entity during the communication to perform a task required by the regulatory healthcare authority in order to obtain the approval for the healthcare product; and

based on the determination, creating a link, via the one or more computer processing modules, between the contact record and a commitment record which records the commitment wherein due to the link, a query about one of the contact record and the commitment record results in presenting both the contact record and the commitment record.

19. The computer-implemented method of claim 18, wherein the commitment record reflects commitments made to the regulatory healthcare authority.

20. The computer-implemented method of claim 18, wherein the commitment includes an agreement to perform a product testing or an obligation to perform a study.

21. The computer-implemented method of claim 18, wherein the contact record stores one or more of a date of the communication, a communication medium, an origin of the communication, a product corresponding to the communication, a manufacturing facility corresponding to the communication, a regulation corresponding to the communication, a reason for the communication;

a region or country discussed during the communication;

a summary of a discussion in the communication, information identifying a person involved in the communication, and a digital representation of a signature of a person responsible for signing the contact record.

22. The computer-implemented method of claim 18, further comprising storing, via database module, a plurality of links among the plurality of regulatory data records, wherein each of the plurality of links implies a relationship among a pair of the plurality of regulatory data records.

23. A computer-implemented method utilized by a healthcare entity for managing and accessing a plurality of regulatory data records related to healthcare and stored by the healthcare entity, the method comprising:

storing, via a memory storage, the plurality of regulatory data records related to healthcare;

generating, via one or more computer processing modules utilized by the healthcare entity, an interlink between two regulatory data records of the plurality of regulatory data records,

wherein the two regulatory data record include a contact report record reflecting a communication between the healthcare entity and a regulatory healthcare authority and a commitment record reflecting a commitment made by the healthcare entity to the regulatory healthcare authority, wherein the communication is related to obtaining approval from the healthcare authority for a healthcare product, the commitment includes an obligation made by the healthcare entity during the communication to perform a task required by the regulatory healthcare authority in order to obtain the approval for the healthcare product, and the interlink is based on a common attribute between the two regulatory data records;

receiving, via an interface module, a query about a first of the two regulatory data records;

presenting the first of the two regulatory data records; and

presenting the second of the two regulatory data records due to the interlink.

24. The computer-implemented method of claim 23, further comprising:

receiving from a user, via the one or more computer processing modules, update information related to the first of the two regulatory data records, wherein the received update information results from the communication between the healthcare entity and the regulatory healthcare authority; and

accordingly creating, via the one or more computer processing modules, the second of the two regulatory data records or issuing a prompt to update the second of the two regulatory data records, wherein creating or updating the second of the two regulatory data records includes creating or updating the commitment record.

25. The computer-implemented method of claim 23, wherein the first or the second of the two regulatory data records is related to plans for filing the healthcare product.

26. The computer-implemented method of claim 23, further comprising:

assigning, via a security module, a security profile to a user; and

presenting to the user a subset of the plurality of regulatory data records, wherein the subset is consistent with the security profile of the user.

27. The computer-implemented method of claim 23 further comprising capturing, via the one or more computer processing modules, an audit trail of modifications to the plurality of regulatory data records.