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Temas is an Italian company offering Regulatory Services and Market Access Temas is part of Quintiles Group, world leader in services for biopharmaceutical companies. The services offered by Tema are: Regulatory Affairs for the development, registration and maintenance of medical products; Pharmacovigilance in clinical trials and post-marketing; Market Access Solutions; Training including seminars, conferences and custom-made training projects. The areas of expertise are medicinal products for human use, medical devices, nutraceuticals, biocides, cosmetics.
Founded in 1994 Tema stands out by representing the first company of outsourced Regulatory services as well as the first company in outsourcing services in Italy to obtain, in 2000, the ISO 9001 certification
- Regulatory Affairs
- Market Access Solutions
The Temas Pharmacovigilance Team offers a wide range of on-demand support activities.
We have between our Medium and Small Pharma customers with extra headquarters in Italy who prefer to outsource this service by meeting the regulatory requirements for pharmacovigilance required by AIFA.
We also provide special support to start-up companies that, in completing all the Italian requirements, need efficient management of local pharmacovigilance activities, meeting the initial needs of not addressing important management costs;
Being part of the Quintiles leader group in Clinical Monitoring and Site Management services gives us the opportunity to handle many Pharmacovigilance clinical trials for many clients.
Post marketing activities
Temas offers the following services:
- QPPV and / or back up administration
- Local Contact Point administration and / or back up
- Registration to Eudravigilance and insertion of ICSR on behalf of the Customer
- Compliance with the specific requirements of the Italian authorities on pharmacovigilance
- Monitoring of the National Pharmacovigilance Network
- Report Management (received from the network, spontaneous, from literature)
- Reconciliation and case filing
- Support to the Customer's Pharmacovigilance System through Audit in preparation for Regulatory Authorities inspections, SOPs processing
- Definition of Security Information Exchange Agreements (SDEA)
- Literature screening
- Training in house and / or at the customer and one to one education programs
- Processing of Periodic Safety Reports
- Maintenance of Medical Product Information (XEVMPD)
- Preparation of the Risk Management Plan (RMP)
- Preparing the Pharmacovigilance System Master File (PSMF)
Pharmacovigilance in Clinical Studies
Management of reports of serious adverse events, notification of relevant cases to the authorities involved, registration to Eudravigilance and inclusion of SUSAR on behalf of the Promoter, preparation of the Development Safety Update Report (DSUR) and submission of the same.
Surveillance on medical devices
Manufacturers, or agents or delegated distributors are required to handle any alteration of the characteristics and performance of a device or any inadequacy in the instructions for use that may cause or have caused the death or serious deterioration of a patient's health condition Or an operator.
They must therefore have an efficient system capable of:
- Collect any information coming from public and / or private operators or legal representatives of public and private healthcare facilities
- Evaluate the event as an Incident and produce an "Initial Incident Report"
- To instigate any verification to determine the causes of it, to arrange any tests
- Have verifications and conclusions to be submitted by the Ministry through the "Final Incident Report"
- Prevent any corrective actions to be communicated to customers and the Ministry of Health through Field Safety Notice (FSN)
Temas is able to provide a watchdog on medical devices by fully supporting companies
Temas may also be in support of the preparation of the Company Quality System MDD, in the preparatory activities to comply with ISO 13485 standards and in the preparation of specific SOPs such as for handling accidents, complaints and product referrals.
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