English to Russian Medical Medical: Pharmaceuticals

All persons to whom the information is disclosed must be informed that it is privileged and/or confidential and may not be further disclosed by them unless prior written consent is gained from our company.
Any information and data generated is owned by our company.
Only authorized regulatory officials, relevant health authority personnel, our company, and its authorized representatives are allowed access to the records.
Program Termination
The objective of this EAP is to provide drug to patients in need of treatment who are otherwise unable to participate in a clinical program or for whom access is otherwise not available through marketed product in their country.
However, Rezolute, reserves the right to terminate the EAP at any time.
In consideration of patient’s best interest, our companyintends to provide physicians and patients reasonable advance notice (1 Month) of the shift to a commercial product, or to the extent possible under the circumstances, EAP discontinuation.
Physicians and patients reserve the right to withdraw their consent to participate in the EAP at any time for any reason.
Please refer to section 4.3.1 regarding Patient Discontinuation.
This program will provide access to patients until:
RZ358 has received marketing authorization, or the product is commercially available and accessible to the participating patient or;
RZ358 is no longer produced or made available by the Supplier or;
The patient no longer fulfils the criteria for the provision of EAP or;
Alternative treatment options (including participation in clinical studies and cohort EAPs) are available and/or;
In case of changes in the safety profile or a lack of overall efficacy of the product or;
The Treating Physician and/or the treatment site no longer meets the requirements with regard to qualification and/or reliability concerning the treatment with RZ358.
Appendix 1:
Schedule of Assessments
Recommendations do not replace investigator determined evaluations as per local standard of care for hyperinsulinism or other medical conditions
Task
Baseline (Visit 1)
Schedule A
(Even Visit #’s starting at Visit 2)
Schedule B
(Odd Visit #’s starting at Visit 3)
Patient Information
X
CHI History
X
Program Visit
(Study Drug Infusion/Continuing Study Question)
X
X
X
SAE Summary
X
X
X
Concomitant Medication
X
X
X
*Glycemic PRO*