Примери за използване на Scientific consultations на Английски и техните преводи на Български
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Joint scientific consultations, whereby developers can seek advice from HTA authorities.
In particular, it includes joint work on clinical assessments,joint scientific consultations and emerging health technologies.
Such national scientific consultations shall be submitted to the Commission for publication on the IT platform referred to in Article 27.
(f) cooperation with the expert panels referred to in Article 106(1) of Regulation(EU)2017/745 on the joint scientific consultations on medical devices.
Joint scientific consultations shall not prejudice the objectivity and independence of joint technological assessments nor its results or conclusions.
The Coordination Group shall include summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27.
The organisational structure should respect the distinctive mandates of the sub-groups conducting the joint clinical assessments and the joint scientific consultations.
(30) During the transitional period, participation in joint clinical assessments and joint scientific consultations should not under any circumstances be mandatory for Member States.
The Commission should endorse, by means of implementing acts, that methodology anda common procedural framework for joint clinical assessments and joint scientific consultations.
The Coordination Group shall include anonymised summary information onpublish the joint scientific consultations in its annual reports andin the IT platform referred to in Article 27.
Joint scientific consultations should concern the clinical study design, the determination of best comparators based on the best medical practice in the interest of patients.
(30) During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States.
Delegates and experts participating in joint scientific consultations for a given health technology shall not participate in the joint clinical assessment of this technology.
Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until….
(21a) Joint scientific consultations should concern the clinical style design and the determination of best comparators based on the best medical practices in the interest of patients.
(26) The Commission should adopt implementing acts on procedural rules for the joint clinical assessments, joint scientific consultations, and for selecting stakeholders.
Delegates participating in the elaboration of joint scientific consultations for a health technology may not participate in the joint clinical assessment of this particular technology.
Assessor and co- assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.
In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group.
The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities andbodies in support of the work on joint clinical assessments and joint scientific consultations.
The Commission should establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments for research on unmet medical needs.
The Commission may establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments which it shall use to finance research regarding unmet medical needs or clinical priorities.
The scientific consultation reports shall be made public upon completion of the joint clinical assessments.
Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate the time-frame.
The scientific consultation reports shall be made public once the joint clinical assessments have been completed.
Support of integrated project teams to participate in the preparation, scientific consultation and full implementation of programs and projects in the interest of defense;
The health technology developer, patients,health professionals and clinical experts may submit comments during the joint scientific consultation.
The designated sub-group shall request the health technology developer to submit the documentation containing the information, data andevidence necessary for the joint scientific consultation.
Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice.