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National Agency for Medicines and
Medical Devices (ANMDM) approved in April 2014 new regulations for (re) approval
of establishments that can conduct clinical trials on medicinal products for
human use (Decision no. 2/22.04.2014 issued by the National Agency Medicines and
Medical Devices and Annexes). According to legislative changes, any medical
facility (medical center, SCM, hospital, etc.) who intend to (re) allow for
clinical trials of therapeutic benefit is required to hold their own standard
operating procedures (Annexes 2 list minimum standard operating procedures) or
be certified to implement a quality management system according to ISO standards
in force trials (Annexes to Decision dated in April 2014 on approval of
Regulations for the approval of establishments that can conduct clinical trials
in medicines for human use - art. 5 (2) d). If your medical center is not ISO
certification, becomes mandatory after 1 year from the entry into force of the
to the said regulations.
In this regard, Mondor Management
supports you, offering advice in developing their own standard operating
procedures (Anexes 2 minimum list of standard operating procedures), mandatory
for running clinical trials. These are:
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procedure on the stages of a
clinical trial;
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procedure for recruitment and
identification of subjects;
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procedure for obtaining informed
consent of the subjects;
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procedures for source documents and
their minimum content of information;
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procedure for assessment and
reporting of serious adverse events;
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procedure for writing procedures;
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procedure for organization of the
team of investigators and delegation of responsibilities within a clinical
trial;
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procedure for study medication -
reception, storage and management;
-
procedure for archiving documents.
Mondor Management will support for the
certification. National Agency for Medicines and Medical Devices has decided
that any medical center to be certified ISO until 22 April 2015. Our company
offers consultancy for ISO certification. You can find more details on our
website at section
Quality
Management and
Stages of
Consultancy.
Quality Management Environmental Management Occupational Health Management
Information Security Management Technical
audit
Clinical
trials Stages of Consultancy
Why Mondor Management Contact
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