Information Management Policy

Information Management Policy

SPERA PHARMA is a Contract Development Manufacturing Organization (CDMO) conducting both CMC R&D and manufacturing of investigational drugs. SPERA PHARMA obtains information from customers and conducts business while providing information to customers, so appropriate information management is considered to be of utmost importance. In order to use our service with confidence we have established and comply with the following policies regarding information management.

1.Maintenance of in-house structure

SPERA PHARMA will maintain an information management system necessary for the protection of all information assets held and establish appropriate internal rules.

2.Assignment of information management supervisors

SPERA PHARMA will assign an information management officer and information managers etc. to accurately grasp the company-wide status of information management and promptly take any necessary measures.

3.Fraud countermeasures regarding information assets

In order to prevent any unauthorized access, destruction, information leakage, or tampering with respect to information assets, SPERA PHARMA implements fraud measures from an organizational, physical and technical viewpoint, which are continually being reviewed and improved.

4.Compliance with laws and contractual requirements

SPERA PHARMA will comply with laws, regulations, norms on information assets used in corporate activities and promises concerning contractual information management made with customers.

5.Employee education

SPERA PHARMA will carry out information management education and training for employees, so that all employees recognize the importance of information management and can carry out business with the necessary knowledge.

6.Implementation of audits

SPERA PHARMA will regularly conduct internal audits of information management in order to verify whether the information management system is functioning effectively, in compliance with laws, regulations, norms and internal rules concerning information management in corporate activities.

7.Management of subcontractors

When SPERA PHARMA entrusts the outsourcing to a third party, it will confirm that they have the level of information management that conforms to SPERA PHARMA’s policies and standards, in the process of reviewing eligibility as a contractor. Also, SPERA PHARMA will periodically confirm that the information management level of outsourcing parties is properly maintained.

8.Response to violations and accidents

SPERA PHARMA shall promptly respond to any infringement of laws, regulations, norms related to information management, breach of contract with customers, or accidental information leakage and reduce the effects of any violations or accidents as much as possible.

Date of enactment: September 26, 2018

SPERA provides CMC solutions from early-stage through new drug application