Rada Evropy potřebuje nahradit zastaralou IT aplikaci na registraci nových léků

Tendr: IT aplikace  (design, development and deployment)

Zadavatel: Rada Evropy (Council of Europe) – European Directorate for the Quality of Medicines and HealthCare

Tendr bude mít 4 fáze:

Stage 1: The Contracting Authority shall draw up a provisional shortlist of minimum two candidates whose bids best respond to the eligibility and award criteria. These candidates shall be invited to take part in the dialogue and discuss all aspects of the contract in order to define the means required to best meet their needs.

Stage 2: Dialogue:  All the aspects of the bid of the candidate shall be discussed during the hearings (scheduled approximately within the first two weeks of September 2018. Additional meetings may be scheduled before the end of 2018).

Stage 3: Submission of final bids by candidates.

Stage 4: Selection of the successful candidate

Background: Before placing a medicinal product on the market, pharmaceutical companies have to obtain a marketing authorisation (MA) from the respective national or European licensing authority. A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) granted by the EDQM (a Directorate of the Council of Europe) replaces the relevant parts demonstrating the quality of substances for pharmaceutical use of the marketing authorisation application (MAA) and simplifies the procedure for authorities and industry. It certifies that the respective substance complies with the European Pharmacopoeia (Ph. Eur.) and that the Ph. Eur. monograph is able to adequately control it (and therefore that the legal requirements are met).

In order to obtain a certificate of suitability (CEP), a substance manufacturer has to submit a dossier, describing how the substance is manufactured and controlled, to the Certification of Substances Department (DCEP) of the EDQM. The DCEP is responsible for the assessment of these files and their lifecycle management.

 The CEP certifies that by applying the relevant monographs of the Ph. Eur., if necessary with an annex appended to the certificate, it is possible to check whether or not the quality of the substance is suitable for use in medicinal products. In other words, it ensures that all possible impurities and contamination from this particular route of manufacture (including source materials) can be fully controlled by the requirements of the monographs.

 In parallel, the DCEP has established a risk-based inspection programme for drug substance manufacturers, to check compliance with the file submitted to EDQM and Good manufacturing practices (GMP).

 To perform the activities related to these processes, the DCEP uses currently an IT application called KEOS, object-oriented application specifically developed for DCEP, running on 4D RDBMS. The DCEP needs to replace this IT application, which has been used since 2007, the aim being to:  manage the daily activities of approx. 45 users within DCEP, in a single IT application or a combination of applications interfacing automatically in a transparent manner for the users  optimise the existing processes and minimise the activities and tasks performed manually and/or using paper documents  have a secure, robust and reliable tool dealing with highly confidential data  have a better integration of the IT application in the EDQM IT environment to avoid entering the same information in different systems and to make the exchange of information/data easier

 have a robust and reliable process for generating documents and communicating easily with applicants.

The IT application should meet the following objectives to perform and follow the majority of the tasks related to the DCEP activities, such as:  recording and managing applications for CEP and their lifecycle   supporting the activities related to the assessment of the dossiers in collaboration with external assessors (allocation of files and collaborative preparation of documents)  establishing and managing information on manufacturing sites and their lifecycle  establishing and managing the inspection programme and its lifecycle  supporting the activities related to the EDQM inspections in collaboration with external inspectors (allocation of inspections and collaborative preparation of documents)  communicating with the applicants for all activities  communicating with authorities (assessors and inspectors, and other stakeholders)  taking actions on the CEPs in case of failures (e.g. suspensions, withdrawals) and communicating with the authorities concerned.

Deadline 31/5