Commercial arrangements (distributors, licensing partners, co-marketing etc.) Technical providers (hosting of computer systems etc.) Individual contractual agreements II.B.4.3. The sources of safety data. The description of the main units for safety data collection. All parties responsible (including third parties). Medical information sites. List describing: (table) Product. Country. Nature of activity. Contact point for the site (address, telephone and The description of the process for ICSRs from Flow diagrams shall be used collection to reporting to national medicines to indicate the main stages, authorities. timeframes and parties involved. For safety data arising from studies. (list/ table) The list should describe, the status of each study/ programme, the applicable country(ies), the product(s) and the main objective. It should distinguish between interventional and studies and should be organised per active substance. The list should include ongoing studies/programmes as well as studies/ programmes completed in the last two years. Computerised systems and databases. II.B.4.4. Validation status of computer The location, functionality and operational responsibility system functionality should for computerised systems and databases used to receive, also be described, the change collate, record and report safety information. control, nature of testing, back-up procedures.
Commercial arrangements (distributors, licensing partners, co-marketing etc.) Technical providers (hosting of computer systems etc.) Individual contractual agreements II.B.4.3. The sources of safety data. The description of the main units for safety data collection. All parties responsible (including third parties). Medical information sites. List describing: (table) Product. Country. Nature of activity. Contact point for the site (address, telephone and The description of the process for ICSRs from collection to reporting to national medicines authorities. Flow diagrams shall be used to indicate the main stages, timeframes and parties involved. For safety data arising from studies. (list/ table) The list should describe, the status of each study/ programme, the applicable country(ies), the product(s) and the main objective. It should distinguish between interventional and studies and should be organised per active substance. The list should include ongoing studies/programmes as well as studies/ programmes completed in the last two years. II.B.4.4. Computerised systems and databases. The location, functionality and operational responsibility for computerised systems and databases used to receive, collate, record and report safety information. Validation status of computer system functionality should also be described, the change control, nature of testing, back-up procedures.
19_195.docx