Method and device for building drug vigilance system, electronic equipment and storage medium

Abstract

The present application provides a method and device for building a drug vigilance system, an electronic device and a storage medium. The method includes: building a drug vigilance system according to the original GVP regulations; obtaining the dynamic changes of the GVP regulations, wherein the dynamic changes are the changes of the new GVP regulations compared with the original GVP regulations; determining the process to be adjusted of the drug vigilance system based on the dynamic changes of the GVP regulations; updating the drug vigilance system according to the process to be adjusted, so that the drug vigilance system can be updated in a timely manner when the relevant regulations of drug vigilance change.

Description

Technical Field

[0001] The present application relates to the field of computer technology, and in particular to a method and device for building a drug vigilance system, an electronic device, and a storage medium. Background Art

[0002] Pharmacovigilance (PV) is the scientific research and activities to discover, evaluate, understand and prevent adverse drug effects or any other drug-related problems. The existing pharmacovigilance system is implemented by manually compiled standard operating procedures (SOPs), and relevant personnel perform their duties based on the SOP to establish a pharmacovigilance system. However, the person in charge of pharmacovigilance cannot dynamically learn about changes in relevant pharmacovigilance regulations, such as the Good Pharmacovigilance Practice (GVP), and cannot quickly interpret relevant pharmacovigilance regulations, resulting in a slow update of the existing pharmacovigilance system, which in turn leads to a long-term risk of non-compliance in pharmacovigilance activities. Summary of the invention

[0003] In view of this, the embodiments of the present application are dedicated to providing a method and device for building a drug vigilance system, an electronic device and a storage medium, which can update the drug vigilance system in a timely manner when the relevant laws and regulations on drug vigilance change.

[0004] According to a first aspect of an embodiment of the present application, a method for building a drug vigilance system is provided, comprising: building the drug vigilance system according to original GVP regulations; obtaining dynamic changes in the GVP regulations, wherein the dynamic changes are changes in the new GVP regulations compared to the original GVP regulations; based on the dynamic changes in the GVP regulations, determining a process to be adjusted in the drug vigilance system; and updating the drug vigilance system according to the process to be adjusted.

[0005] In one embodiment, the obtaining of the dynamic changes of the GVP regulations includes: obtaining the new GVP regulations; and interpreting the new GVP regulations to obtain the dynamic changes of the GVP regulations.

[0006] In one embodiment, the obtaining of the new GVP regulations includes: crawling the new GVP regulations from different websites, or receiving the new GVP regulations sent by different websites.

[0007] In one embodiment, the interpreting the new GVP regulations to obtain dynamic changes of the GVP regulations includes: obtaining the dynamic changes of the GVP regulations through a network model according to the original GVP regulations and the new GVP regulations.

[0008] In one embodiment, the method further includes: obtaining a mapping relationship table between the original GVP regulations and various processes of the drug vigilance system, wherein the mapping relationship table is used to store the mapping relationship between the original regulatory keywords of the original GVP regulations and the corresponding processes.

[0009] In one embodiment, the interpretation of the new GVP regulations to obtain the dynamic changes of the GVP regulations includes: determining new regulatory keywords of the new GVP regulations based on the original regulatory keywords in the mapping relationship table; comparing the original regulatory keywords with the new regulatory keywords to determine the dynamic changes of the GVP regulations.

[0010] In one embodiment, determining the process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations includes: locating the process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations.

[0011] In one embodiment, updating the drug vigilance system according to the process to be adjusted includes: improving the process to be adjusted based on the dynamic changes of the GVP regulations, wherein the improvement includes improving the process to be adjusted itself and / or improving the files configured for the process to be adjusted.

[0012] In one embodiment, determining the process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations includes: adding the process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations.

[0013] In one embodiment, updating the pharmacovigilance system according to the process to be adjusted includes: configuring a file for the process to be adjusted based on dynamic changes in the GVP regulations.

[0014] According to the second aspect of an embodiment of the present application, a device for building a drug vigilance system is provided, comprising: a building module, configured to build the drug vigilance system according to the original GVP regulations; an acquisition module, configured to acquire dynamic changes of the GVP regulations, wherein the dynamic changes are differences between the new GVP regulations and the original GVP regulations; a determination module, configured to determine a process to be adjusted of the drug vigilance system based on the dynamic changes of the GVP regulations; and an update module, configured to update the drug vigilance system according to the process to be adjusted.

[0015] In some embodiments, the device further includes: a module for executing each step in the method mentioned in the above embodiments.

[0016] According to a third aspect of an embodiment of the present application, an electronic device is provided, comprising: a processor; a memory for storing instructions executable by the processor; and the processor is used to execute the method described in any one of the above embodiments.

[0017] According to a fourth aspect of the embodiments of the present application, a computer-readable storage medium is provided, wherein the storage medium stores a computer program, and the computer program is used to execute the method described in any of the above embodiments.

[0018] The embodiment of the present application provides a method for building a drug vigilance system. By automatically acquiring the dynamic changes of the original GVP regulations, it is possible to determine the process to be adjusted of the drug vigilance system built based on the original GVP regulations, and update the drug vigilance system according to the process to be adjusted, so that the drug vigilance system can be updated in a timely manner when the relevant regulations on drug vigilance change. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 Shown is a schematic diagram of an implementation environment provided by an embodiment of the present application.

[0020] Figure 2 The figure is a schematic diagram of a process for building a drug vigilance system provided in one embodiment of the present application.

[0021] Figure 3 The figure is a schematic diagram of a process for building a drug vigilance system provided in one embodiment of the present application.

[0022] Figure 4 The figure is a schematic diagram of a process for building a drug vigilance system provided in one embodiment of the present application.

[0023] Figure 5 The figure is a schematic diagram of a process for building a drug vigilance system provided in one embodiment of the present application.

[0024] Figure 6 The figure shows a block diagram of a device for building a drug vigilance system provided by one embodiment of the present application.

[0025] Figure 7 Shown is a structural block diagram of an electronic device provided by an embodiment of the present application. DETAILED DESCRIPTION

[0026] The exemplary embodiments will be described in detail below, examples of which are shown in the accompanying drawings. When the following description refers to the drawings, the same numbers in different drawings represent the same or similar elements unless otherwise indicated. The implementations described in the following exemplary embodiments do not represent all implementations consistent with the present application. Instead, they are only examples of devices and methods consistent with some aspects of the present application as detailed in the attached claims.

[0027] The terms used in this application are only for the purpose of describing specific embodiments, and are not intended to limit the application. The singular forms of "a", "said" and "the" used in this application and the appended claims are also intended to include plural forms, unless other meanings are clearly indicated below. It should also be understood that the term "and / or" used in this article refers to and includes any or all possible combinations of one or more associated listed items. It should also be understood that the word "if" used in this article, depending on the context, can be interpreted as "at the time of" or "when" or "in response to determining".

[0028] The pharmacovigilance system is a system built around pharmacovigilance, which usually complies with certain pharmacovigilance management standards, such as GVP regulations. The pharmacovigilance system typically includes two categories: compliance work and pharmacovigilance work. Compliance work is reflected in the integrity, good planning, executableness, and traceability of the system process. All due diligence work must be completed to be called compliance. Pharmacovigilance work mainly starts from data, focuses on product safety itself, conducts data analysis, and summarizes and discovers risks.

[0029] GVP regulations are formulated to regulate drug vigilance activities throughout the life cycle of drugs. Pharmacovigilance activities are carried out according to the safety characteristics of drugs to minimize drug safety risks and protect and promote public health. According to GVP regulations, quality goals are set, quality assurance systems are established, quality management of drug vigilance systems and activities is carried out, the operational efficiency of drug vigilance systems is continuously improved, and drug vigilance activities are ensured to continue to comply with relevant laws and regulations.

[0030] However, pharmacovigilance managers are unable to dynamically learn about changes in GVP regulations and are unable to quickly interpret GVP regulations, resulting in slow updates to the existing pharmacovigilance system and, in turn, long-term risks of non-compliance in pharmacovigilance activities.

[0031] In order to solve the above problems, the embodiments of the present application can determine the process to be adjusted of the drug vigilance system automatically built based on the original GVP regulations by automatically acquiring the dynamic changes of the original GVP regulations, and update the drug vigilance system according to the process to be adjusted, so that the drug vigilance system can be updated in time when the GVP regulations of drug vigilance change.

[0032] In addition, even if the person in charge of pharmacovigilance can accidentally learn about changes in GVP regulations, he or she still needs to manually update the pharmacovigilance system, which has a very low update efficiency and is prone to erroneous updates due to human factors.

[0033] In order to solve the above problems, after automatically acquiring the dynamic changes of the original GVP regulations, the embodiments of the present application can automatically determine the process to be adjusted of the drug vigilance system, and update the drug vigilance system automatically built based on the original GVP regulations according to the process to be adjusted, thereby improving the update efficiency and avoiding erroneous updates.

[0034] Combine the following Figure 1 , the implementation scenario of the drug vigilance system provided in the embodiment of the present application is illustrated in more detail.

[0035] like Figure 1 As shown, the implementation scenario includes: a server 140 and multiple terminal devices 110, 120, 130 (ie, user terminals).

[0036] The terminal devices 110, 120, 130 may be mobile terminal devices such as mobile phones, game consoles, tablet computers, or the terminal devices 110, 120, 130 may also be personal computers (PCs), such as laptop computers and desktop computers, etc. Those skilled in the art will appreciate that the types of the terminal devices 110, 120, 130 may be the same or different, and their number may be more or less. For example, there may be one terminal each, or there may be dozens or hundreds of terminals, or a greater number. The disclosed embodiments do not limit the number of terminals and device types. The servers 110a, 120a, 130a corresponding to the terminal devices 110, 120, 130 are installed with a drug vigilance system, which is automatically built by the original GVP regulations.

[0037] The terminal devices 110, 120, 130 are connected to the server 140 via a communication network. Optionally, the communication network is a wired network or a wireless network. Optionally, the server 140 is a server, or is composed of several servers, or is a virtualization platform, or is a cloud computing service center.

[0038] In some embodiments, the terminal devices 110, 120, 130 obtain new GVP regulations from the server 140. The servers 110a, 120a, 130a obtain new GVP regulations from the terminal devices 110, 120, 130, interpret the new GVP regulations to obtain dynamic changes in the GVP regulations, and then determine the process to be adjusted of the pharmacovigilance system based on the dynamic changes in the GVP regulations, and then update the pharmacovigilance system according to the process to be adjusted, and finally send the updated pharmacovigilance system to the terminal devices 110, 120, 130.

[0039] In some embodiments, the servers 110a, 120a, and 130a may be connected to the server 140 via a communication network. Optionally, the communication network is a wired network or a wireless network, and the servers 110a, 120a, and 130a may directly obtain the new GVP regulations from the server 140. The servers 110a, 120a, and 130a interpret the new GVP regulations to obtain the dynamic changes of the GVP regulations, and then determine the process to be adjusted of the pharmacovigilance system based on the dynamic changes of the GVP regulations, and then update the pharmacovigilance system according to the process to be adjusted, and finally send the updated pharmacovigilance system to the terminal devices 110, 120, and 130.

[0040] By automatically acquiring the dynamic changes of the original GVP regulations, it is possible to determine the process to be adjusted of the drug vigilance system built based on the original GVP regulations, and update the drug vigilance system according to the process to be adjusted, so that the drug vigilance system can be updated in a timely manner when the relevant regulations on drug vigilance change.

[0041] Combination of the above Figure 1 , the implementation scenario provided by the embodiment of the present application is described in detail with examples. Figures 2 to 5 The method for building the drug vigilance system mentioned in the embodiments of the present application is introduced in detail.

[0042] Figure 2 The figure is a schematic diagram of a process for building a drug vigilance system provided in one embodiment of the present application. Figure 2 The method is performed by a device (e.g., a server or other type of electronic device with data processing function) where the pharmacovigilance system is located, such as Figure 2 As shown, the method includes the following contents.

[0043] S210: Establish a pharmacovigilance system according to the original GVP regulations.

[0044] The pharmacovigilance system is an indispensable and important part of the industry. The existing pharmacovigilance system is implemented by manually compiled documents SOP. Relevant personnel perform their duties based on SOP to establish a pharmacovigilance system. However, this requires high business capabilities of relevant personnel. All participants need to undergo training and combine SOP to clarify their respective responsibilities, resulting in low efficiency in the construction of the pharmacovigilance system.

[0045] Therefore, the embodiment of the present application automatically builds a drug vigilance system through the original GVP regulations, which can not only improve the efficiency of building the drug vigilance system, but also reduce the workload of relevant personnel.

[0046] S220: Obtain dynamic changes of GVP regulations, wherein the dynamic changes are changes in the new GVP regulations compared with the original GVP regulations.

[0047] When the GVP regulations change, if the pharmacovigilance system is not updated in time, there will be a risk of non-compliance in pharmacovigilance activities. Therefore, by comparing the new GVP regulations with the original GVP regulations, we can know the changes in the new GVP regulations compared to the original GVP regulations, thereby obtaining the dynamic changes of the GVP regulations.

[0048] However, it should be noted that the embodiments of the present application do not specifically limit how to obtain the dynamic changes of GVP regulations, and those skilled in the art may make different choices based on actual needs.

[0049] S230: Based on the dynamic changes in GVP regulations, determine the processes to be adjusted in the pharmacovigilance system.

[0050] The drug vigilance system includes multiple processes, each of which is also configured with files. When the GVP regulations change, the multiple processes in the drug vigilance system will also change accordingly. For example, a process in the drug vigilance system itself may change, or a new process may be added to the drug vigilance system. The embodiments of the present application do not specifically limit this.

[0051] S240: Update the pharmacovigilance system according to the process to be adjusted.

[0052] When GVP regulations change, not only will the processes in the pharmacovigilance system change, but the files configured for each process in the pharmacovigilance system will also change accordingly. Therefore, after each adjustment to the process in the pharmacovigilance system, its supporting files will also be adaptively adjusted, for example, by modifying the supporting files or deleting invalid supporting files, thereby completing the update of the pharmacovigilance system.

[0053] In one embodiment, the impact point on the pharmacovigilance system is determined according to the dynamic change, and then the process to be adjusted is determined according to the impact point. The process to be adjusted can be an existing process in the pharmacovigilance system or a new process in the pharmacovigilance system.

[0054] In one embodiment, when the process to be adjusted is an existing process in the drug vigilance system, the process to be adjusted can be adaptively improved based on the dynamic changes in GVP regulations, for example, the process to be adjusted itself can be improved, or the files configured for the process to be adjusted can be improved. This embodiment of the present application does not specifically limit this.

[0055] In another embodiment, when the process to be adjusted is a new process in the pharmacovigilance system, a new process to be adjusted can be added to the pharmacovigilance system based on the dynamic changes in GVP regulations, and a configuration file for the process to be adjusted can be created. It should be noted that the embodiments of the present application do not specifically limit how to determine the process to be adjusted, and those skilled in the art can make different choices based on actual needs.

[0056] The embodiments of the present application can determine the process to be adjusted of the drug vigilance system built based on the original GVP regulations by automatically acquiring the dynamic changes of the GVP regulations, and update the drug vigilance system according to the process to be adjusted, so that the drug vigilance system can be updated in a timely manner when the relevant regulations on drug vigilance change.

[0057] In another embodiment of the present application, Figure 3 The method shown is Figure 2 An example of the method shown is Figure 3 The method shown also includes the following.

[0058] Figure 3 Step S310 in the method shown is Figure 2 The step S210 in the method shown is the same, and the specific details will not be repeated here, see Figure 2 Step S210 in the method shown.

[0059] S320: Obtain new GVP regulations.

[0060] In one embodiment, new GVP regulations can be crawled from different websites, and new GVP regulations sent by different websites can also be received. Specifically, GVP regulations can be subscribed to different columns of different websites, or GVP regulations from different websites can be automatically received, or regulatory monitoring information processed by TM-PV can be browsed.

[0061] S330: Interpret the new GVP regulations to obtain the dynamic changes of GVP regulations.

[0062] In one embodiment, the new GVP regulations are automatically interpreted using a deep learning method or a machine learning method, that is, the dynamic changes of the GVP regulations are obtained through a network model based on the original GVP regulations and the new GVP regulations.

[0063] Specifically, the original GVP regulations are input into the network model so that the network model learns the characteristics of the original GVP regulations. At the same time, the new GVP regulations are input into the network model so that the network model learns the characteristics of the new GVP regulations. In this way, the network model can learn the dynamic changes of GVP regulations by comparing the differences between the original GVP regulations and the new GVP regulations.

[0064] The embodiment of the present application does not limit the specific type of the network model. The network model can be a shallow model obtained by machine learning, such as a SWM classifier, or a linear regression classifier, etc. The network model obtained by machine learning can achieve rapid difference recognition to improve efficiency; the network model can also refer to a deep model obtained by deep learning. The network model can be composed of any type of neural network, and these networks can be based on ResNet, ResNeXt or DenseNet, etc. The network model obtained by deep learning can improve the accuracy of model recognition differences. Optionally, the network model can be a convolutional neural network (CNN), a deep neural network (DNN) or a recurrent neural network (RNN). The network model may include neural network layers such as input layer, convolution layer, pooling layer, connection layer, etc., and the embodiment of the present application does not specifically limit this. In addition, the embodiment of the present application does not limit the number of each neural network layer.

[0065] In one embodiment, a mapping relationship table between the original GVP regulations and various processes of the pharmacovigilance system is first obtained. The mapping relationship table is used to store the mapping relationship between the original regulation keywords of the original GVP regulations and the corresponding processes. That is, each regulation in the original GVP regulations will correspond to a process of the pharmacovigilance system, and each regulation will correspond to an original regulation keyword. Therefore, an original regulation keyword will correspond to a process. The mapping relationship between the original regulation keyword and the corresponding process is stored in the mapping relationship table, so there are many mapping relationships stored in the mapping relationship table.

[0066] In one embodiment, new regulatory keywords of the new GVP regulations are determined based on the original regulatory keywords in the mapping relationship table. Specifically, by querying the original regulatory keywords in the mapping relationship table, keywords corresponding to the original regulatory keywords can be located in the new GVP regulations, which indicates that the dynamic changes of the GVP regulations are improvements made on the basis of the original GVP regulations, and the keywords corresponding to the original regulatory keywords are determined to be new regulatory keywords; by querying the original regulatory keywords in the mapping relationship table, keywords corresponding to the original regulatory keywords cannot be located in the new GVP regulations, which indicates that the dynamic changes of the GVP regulations are improvements newly added to the original GVP regulations, and the new regulatory keywords are interpreted in the new GVP regulations.

[0067] By searching for the original regulatory keywords in the mapping relationship table, it is possible to avoid analyzing all the contents of the new GVP regulations, thus saving time in interpretation.

[0068] In one embodiment, the original regulatory keywords are compared with the new regulatory keywords. When there is a certain degree of similarity between the original regulatory keywords and the new regulatory keywords, the difference between the two is determined. The difference is the change of the new GVP regulations compared with the original GVP regulations, thereby determining the dynamic change of the GVP regulations.

[0069] In another embodiment, the original regulatory keywords are compared with the new regulatory keywords. When the original regulatory keywords are completely different from the new regulatory keywords, it is determined that the regulatory content where the new regulatory keywords are located is a dynamic change of the GVP regulations.

[0070] It should be noted that the embodiments of the present application do not specifically limit how to interpret the new GVP regulations, and those skilled in the art may make different choices based on actual needs.

[0071] Figure 3 Steps S340 and S350 in the method shown are respectively Figure 2 Steps S230 and S240 in the method shown are the same, and the specific details will not be repeated here, see Figure 2 Steps S230 and S240 in the method shown.

[0072] In another embodiment of the present application, Figure 4 The method shown is Figure 2 An example of the method shown is Figure 4 The method shown also includes the following.

[0073] Figure 4 Steps S410 and S420 in the method shown are similar to Figure 2 Steps S210 and S220 in the method shown are the same, and the specific details will not be repeated here, see Figure 2Steps S210 and S220 in the method shown.

[0074] S430: Locate processes to be adjusted in the pharmacovigilance system based on dynamic changes in GVP regulations.

[0075] In one embodiment, when it is determined that the process to be adjusted is an existing process in the pharmacovigilance system, this indicates that the dynamic change of the GVP regulations is an improvement based on the original GVP regulations. Since the dynamic change of the GVP regulations includes the differences between the original regulation keywords and the new regulation keywords, the original regulation keywords can be used to Figure 3 The mapping relationship table in the illustrated embodiment locates the process corresponding to the original regulatory keyword, and the process corresponding to the original regulatory keyword is the process to be adjusted.

[0076] Of course, the embodiments of the present application do not specifically limit the method of locating the process to be adjusted. It is also possible to first determine the keywords corresponding to the dynamic changes of the GVP regulations, and then locate the process to be adjusted in the drug vigilance system based on the keywords corresponding to the dynamic changes.

[0077] Figure 4 Step S440 in the method shown is Figure 2 The step S240 in the method shown is the same, and the specific details will not be repeated here, see Figure 2 Step S240 in the method shown.

[0078] In another embodiment of the present application, Figure 5 The method shown is Figure 2 An example of the method shown is Figure 5 The method shown also includes the following.

[0079] Figure 5 Steps S510 and S520 in the method shown are similar to Figure 2 Steps S210 and S220 in the method shown are the same, and the specific details will not be repeated here, see Figure 2 Steps S210 and S220 in the method shown.

[0080] S530: Based on the dynamic changes in GVP regulations, new processes to be adjusted are added to the pharmacovigilance system.

[0081] In one embodiment, when it is determined that the process to be adjusted is a new process in the pharmacovigilance system, this indicates that the dynamic changes in the GVP regulations are new improvements relative to the original GVP regulations, and there is no process corresponding to the new improvements in the pharmacovigilance system. Therefore, based on the dynamic changes in the GVP regulations, the SOP in the pharmacovigilance system can be further expanded, that is, a new process to be adjusted is added to the pharmacovigilance system.

[0082] Figure 5 Step S540 in the method shown is the same as Figure 2 The step S240 in the method shown is the same, and the specific details will not be repeated here, see Figure 2 Step S240 in the method shown.

[0083] In another embodiment of the present application, the method further includes: sending the task corresponding to the process to be adjusted in the updated drug vigilance system to the user terminal, so that the task corresponding to the process to be adjusted is pushed to the user at the user terminal for execution.

[0084] In another embodiment of the present application, the method further includes: storing keywords corresponding to dynamic changes in GVP regulations. When other relevant GVP regulations change, there is no need to interpret other relevant GVP regulations again, and the keywords corresponding to the dynamic changes can be directly used.

[0085] Combination of the above Figures 2 to 5 , describes the method embodiment of the present application in detail, and the following is combined with Figure 6 , describes the device embodiment of the present application in detail. It should be understood that the description of the method embodiment corresponds to the description of the device embodiment, so the parts not described in detail can refer to the previous method embodiment.

[0086] Figure 6 FIG. 1 is a block diagram of a device for building a drug vigilance system according to an embodiment of the present application. Figure 6 As shown, the device 600 includes:

[0087] A building module 610 is configured to build a pharmacovigilance system according to the original GVP regulations;

[0088] An acquisition module 620, configured to acquire dynamic changes of the GVP regulations, wherein the dynamic changes are differences between the new GVP regulations and the original GVP regulations;

[0089] A determination module 630, configured to determine a process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations;

[0090] The updating module 640 is configured to update the pharmacovigilance system according to the process to be adjusted.

[0091] A method for building a drug vigilance system provided in an embodiment of the present application can determine the process to be adjusted of the drug vigilance system built based on the original GVP regulations by automatically acquiring the dynamic changes of the original GVP regulations, and update the drug vigilance system according to the process to be adjusted, so that the drug vigilance system can be updated in a timely manner when the relevant regulations on drug vigilance change.

[0092] In one embodiment, the acquisition module 620 is further configured to: acquire the new GVP regulations; and interpret the new GVP regulations to obtain dynamic changes of the GVP regulations.

[0093] In one embodiment, when acquiring the new GVP regulations, the acquisition module 620 is further configured to: crawl the new GVP regulations from different websites, or receive the new GVP regulations sent by different websites.

[0094] In one embodiment, when the acquisition module 620 interprets the new GVP regulations to obtain the dynamic changes of the GVP regulations, it is further configured to: obtain the dynamic changes of the GVP regulations through a network model according to the original GVP regulations and the new GVP regulations.

[0095] In one embodiment, the device 600 also includes: a re-acquisition module, configured to obtain a mapping relationship table between the original GVP regulations and the various processes of the drug vigilance system, wherein the mapping relationship table is used to store the mapping relationship between the original regulatory keywords of the original GVP regulations and the corresponding processes.

[0096] In one embodiment, when the acquisition module 620 interprets the new GVP regulations to obtain the dynamic changes of the GVP regulations, it is further configured to: determine the new regulatory keywords of the new GVP regulations based on the original regulatory keywords in the mapping relationship table; compare the original regulatory keywords with the new regulatory keywords to determine the dynamic changes of the GVP regulations.

[0097] In one embodiment, the determination module 630 is further configured to locate the process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations.

[0098] In one embodiment, the device 600 also includes: an improvement module, configured to improve the process to be adjusted based on the dynamic changes of the GVP regulations, wherein the improvement includes improving the process to be adjusted itself and / or improving the files configured for the process to be adjusted.

[0099] In one embodiment, the determination module 630 is further configured to: based on the dynamic changes of the GVP regulations, add the process to be adjusted in the pharmacovigilance system.

[0100] In one embodiment, the device 600 further includes: a configuration module configured to configure the process profile to be adjusted based on the dynamic changes of the GVP regulations.

[0101] Below, reference Figure 7 An electronic device according to an embodiment of the present application is described. Figure 7 1 shows a block diagram of an electronic device according to an embodiment of the present application.

[0102] like Figure 7 As shown, the electronic device 700 includes one or more processors 710 and a memory 720.

[0103] The processor 710 may be a central processing unit (CPU) or other forms of processing units having data processing capabilities and / or instruction execution capabilities, and may control other components in the electronic device 700 to perform desired functions.

[0104] The memory 720 may include one or more computer program products, which may include various forms of computer-readable storage media, such as volatile memory and / or non-volatile memory. The volatile memory may include, for example, a random access memory (RAM) and / or a cache memory (cache), etc. The non-volatile memory may include, for example, a read-only memory (ROM), a hard disk, a flash memory, etc. One or more computer program instructions may be stored on the computer-readable storage medium, and the processor 710 may execute the program instructions to implement the above-described method for building a pharmacovigilance system of each embodiment of the present application / or other desired functions.

[0105] In one example, the electronic device 700 may further include: an input device 730 and an output device 740 , and these components are interconnected via a bus system and / or other forms of connection mechanisms (not shown).

[0106] For example, the input device 730 may be the microphone or microphone array mentioned above. In addition, the input device 730 may also include, for example, a keyboard, a mouse, and the like.

[0107] The output device 740 can output various information to the outside, including dynamic changes, etc. The output device 740 can include, for example, a display, a speaker, a printer, a communication network and a remote output device connected thereto, and the like.

[0108] Of course, to simplify, Figure 7Only some of the components related to the present application in the electronic device 700 are shown, and components such as a bus, an input / output interface, etc. are omitted. In addition, according to specific application conditions, the electronic device 700 may also include any other appropriate components.

[0109] In addition to the above-mentioned methods and devices, an embodiment of the present application may also be a computer program product, which includes computer program instructions, which, when executed by a processor, enable the processor to execute the steps in the method for building a drug vigilance system described in the above-mentioned embodiments of this specification.

[0110] The computer program product may be written in any combination of one or more programming languages ​​to write program codes for performing the operations of the embodiments of the present application, including object-oriented programming languages, such as Java, C++, etc., and conventional procedural programming languages, such as "C" language or similar programming languages. The program code may be executed entirely on the user computing device, partially on the user device, as an independent software package, partially on the user computing device and partially on a remote computing device, or entirely on a remote computing device or server.

[0111] In addition, an embodiment of the present application may also be a computer-readable storage medium on which computer program instructions are stored. When the computer program instructions are executed by a processor, the processor executes the steps in the method for building a drug vigilance system in the above embodiment of this specification.

[0112] The computer readable storage medium can adopt any combination of one or more readable media. The readable medium can be a readable signal medium or a readable storage medium. The readable storage medium can include, for example, but is not limited to, a system, device or device of electricity, magnetism, light, electromagnetic, infrared, or semiconductor, or any combination of the above. More specific examples (non-exhaustive list) of readable storage media include: an electrical connection with one or more wires, a portable disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above.

[0113] The above description has been given for the purpose of illustration and description. In addition, this description is not intended to limit the embodiments of the present application to the forms disclosed herein. Although multiple example aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, changes, additions and sub-combinations thereof.

Claims

1. A method for building a drug vigilance system, characterized in that: include: According to the original GVP regulations, the pharmacovigilance system is built, wherein the GVP regulations are specifications formulated to regulate pharmacovigilance activities throughout the life cycle of drugs, and according to the GVP regulations, quality objectives are formulated, a quality assurance system is established, and quality management of the pharmacovigilance system and activities is performed; Crawl new GVP regulations from different websites, or receive new GVP regulations sent by different websites; According to the original GVP regulations and the new GVP regulations, automatically interpreting the new GVP regulations by using a deep learning method or a machine learning method; Inputting the original GVP regulations into the network model so that the network model learns the characteristics of the original GVP regulations; Then, the new GVP regulations are input into the network model, so that the network model learns the characteristics of the new GVP regulations; The network model learns the dynamic changes of the GVP regulations by comparing the differences between the original GVP regulations and the new GVP regulations; or Obtaining a mapping relationship table between the original GVP regulations and various processes of the pharmacovigilance system, wherein the mapping relationship table is used to store the mapping relationship between the original regulatory keywords of the original GVP regulations and the corresponding processes; Determining new regulatory keywords for the new GVP regulations based on the original regulatory keywords in the mapping relationship table; Comparing the original regulation keywords with the new regulation keywords, determining the dynamic changes of the GVP regulations, wherein the dynamic changes are changes in the new GVP regulations compared to the original GVP regulations; Determine the process to be adjusted in the pharmacovigilance system based on the dynamic changes of the GVP regulations; The drug vigilance system is updated according to the process to be adjusted.

2. The method according to claim 1, characterized in that Determining the process to be adjusted of the pharmacovigilance system based on the dynamic changes of the GVP regulations includes: Based on the dynamic changes of the GVP regulations, the process to be adjusted is located in the pharmacovigilance system.

3. The method according to claim 2, characterized in that The updating of the pharmacovigilance system according to the process to be adjusted includes: Based on the dynamic changes of the GVP regulations, the process to be adjusted is improved, wherein the improvement includes improving the process to be adjusted itself and / or improving the files configured for the process to be adjusted.

4. The method according to claim 1, characterized in that: Determining the process to be adjusted of the pharmacovigilance system based on the dynamic changes of the GVP regulations includes: Based on the dynamic changes of the GVP regulations, the process to be adjusted is added to the pharmacovigilance system.

5. The method according to claim 4, characterized in that The updating of the pharmacovigilance system according to the process to be adjusted includes: Based on the dynamic changes of the GVP regulations, the process profile to be adjusted is configured.

6. A device for building a drug vigilance system, characterized in that: include: A building module, configured to build the pharmacovigilance system according to the original GVP regulations, wherein the GVP regulations are specifications formulated to regulate pharmacovigilance activities throughout the life cycle of drugs, and according to the GVP regulations, formulate quality goals, establish a quality assurance system, and perform quality management on the pharmacovigilance system and activities; An acquisition module, configured to crawl new GVP regulations from different websites, or receive new GVP regulations sent by different websites; According to the original GVP regulations and the new GVP regulations, automatically interpreting the new GVP regulations by using a deep learning method or a machine learning method; Inputting the original GVP regulations into the network model so that the network model learns the characteristics of the original GVP regulations; Then, the new GVP regulations are input into the network model, so that the network model learns the characteristics of the new GVP regulations; The network model learns the dynamic changes of the GVP regulations by comparing the differences between the original GVP regulations and the new GVP regulations; or Obtaining a mapping relationship table between the original GVP regulations and various processes of the pharmacovigilance system, wherein the mapping relationship table is used to store the mapping relationship between the original regulatory keywords of the original GVP regulations and the corresponding processes; Determining new regulatory keywords for the new GVP regulations based on the original regulatory keywords in the mapping relationship table; Comparing the original regulation keywords with the new regulation keywords, determining the dynamic changes of the GVP regulations, wherein the dynamic changes are the differences between the new GVP regulations and the original GVP regulations; A determination module configured to determine a process to be adjusted in the pharmacovigilance system based on dynamic changes in the GVP regulations; An updating module is configured to update the drug vigilance system according to the process to be adjusted.

7. An electronic device comprising: A processor, configured to execute the method according to any one of claims 1 to 5; as well as A memory for storing executable instructions for the processor.

8. A computer-readable storage medium having computer-executable instructions stored thereon, characterized in that: When the executable instructions are executed by a processor, the method according to any one of claims 1 to 5 is implemented.

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