Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the m...Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws.Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system.We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system,which includes building a sound pharmacovigilance organizational structure,establishing a series of operational system files and cultivating professional talents.MAHs of China should improve the structure of enterprise pharmacovigilance system.Besides,members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment.If MAHs possess a large variety and quantity of products,a Drug Safety Committee should be established to ensure the timely discovery of risks.In addition,MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant,effective and operatable files combing with the actual operation of pharmacovigilance system.Finally,MAHs should introduce and train pharmacovigilance talents,and hire pharmacovigilance experts as consultants to solve the problem of talent shortage.展开更多
These days,data is regarded as a valuable asset in the era of the data economy,which demands a trading platform for buying and selling data.However,online data trading poses challenges in terms of security and fairnes...These days,data is regarded as a valuable asset in the era of the data economy,which demands a trading platform for buying and selling data.However,online data trading poses challenges in terms of security and fairness because the seller and the buyer may not fully trust each other.Therefore,in this paper,a blockchain-based secure and fair data trading system is proposed by taking advantage of the smart contract and matchmaking encryption.The proposed system enables bilateral authorization,where data trading between a seller and a buyer is accomplished only if their policies,required by each other,are satisfied simultaneously.This can be achieved by exploiting the security features of the matchmaking encryption.To guarantee non-repudiation and fairness between trading parties,the proposed system leverages a smart contract to ensure that the parties honestly carry out the data trading protocol.However,the smart contract in the proposed system does not include complex cryptographic operations for the efficiency of onchain processes.Instead,these operations are carried out by off-chain parties and their results are used as input for the on-chain procedure.The system also uses an arbitration protocol to resolve disputes based on the trading proof recorded on the blockchain.The performance of the protocol is evaluated in terms of off-chain computation overhead and on-chain gas consumption.The results of the experiments demonstrate that the proposed protocols can enable the implementation of a cost-effective data trading system.展开更多
基金Integration Application Status and Problems Investigation of ICH Q8,Q9,Q10 across the Product Life Cycle(No.20210605).
文摘Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws.Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system.We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system,which includes building a sound pharmacovigilance organizational structure,establishing a series of operational system files and cultivating professional talents.MAHs of China should improve the structure of enterprise pharmacovigilance system.Besides,members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment.If MAHs possess a large variety and quantity of products,a Drug Safety Committee should be established to ensure the timely discovery of risks.In addition,MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant,effective and operatable files combing with the actual operation of pharmacovigilance system.Finally,MAHs should introduce and train pharmacovigilance talents,and hire pharmacovigilance experts as consultants to solve the problem of talent shortage.
基金supported by Basic Science Research Program through the National Research Foundation of Korea(NRF)funded by the Ministry of Education(No.2022R1I1A3063257)supported by Electronics and Telecommunications Research Institute(ETRI)grant funded by the Korean Government[22ZR1300,Research on Intelligent Cyber Security and Trust Infra].
文摘These days,data is regarded as a valuable asset in the era of the data economy,which demands a trading platform for buying and selling data.However,online data trading poses challenges in terms of security and fairness because the seller and the buyer may not fully trust each other.Therefore,in this paper,a blockchain-based secure and fair data trading system is proposed by taking advantage of the smart contract and matchmaking encryption.The proposed system enables bilateral authorization,where data trading between a seller and a buyer is accomplished only if their policies,required by each other,are satisfied simultaneously.This can be achieved by exploiting the security features of the matchmaking encryption.To guarantee non-repudiation and fairness between trading parties,the proposed system leverages a smart contract to ensure that the parties honestly carry out the data trading protocol.However,the smart contract in the proposed system does not include complex cryptographic operations for the efficiency of onchain processes.Instead,these operations are carried out by off-chain parties and their results are used as input for the on-chain procedure.The system also uses an arbitration protocol to resolve disputes based on the trading proof recorded on the blockchain.The performance of the protocol is evaluated in terms of off-chain computation overhead and on-chain gas consumption.The results of the experiments demonstrate that the proposed protocols can enable the implementation of a cost-effective data trading system.
