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Creating value through managing idea from bench to clinicWorking together to secure successful regulatory approvalProviding creative solutions to the healthcare industry
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Creating value through managing idea from bench to clinicWorking together to secure successful regulatory approvalProviding creative solutions to the healthcare industry
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Regulatory Affairs Consulting
News & Events
פגישות היכרות, ליעוץ רגולטורי, תכנון וביצוע ניסויים קליניים לחברות הזנק
07/02/2024
B.R.D Bio Medical Research Design Ltd. is taking part in the Israeli conference for life sciences and health technologies, of the Israeli Association for Advanced …
פורסמה טיוטת נוהל הגשת שינויים במסמכי ניסויים קליניים
06/09/2023
המחלקה לניסויים קליניים פרסמה להערות הציבור את פרק 4 לנוהל משרד הבריאות לביצוע ניסויים רפואיים בבני אדם בישראל. הנוהל נועד להחליף את הנאמר בסעיף 4.8.1 …
קובץ הנחיות חדש לכתב והליך ההסכמה פורסם ע”י מנהל המזון והתרופות בארה”ב
06/09/2023
מנהל המזון והתרופות האמריקאי ה- FDA פרסם קובץ הנחיות מפורט לדרישות נוסח כתב ההסכמה וביצוע הליך ההסכמה ותיעודו. המסמך שכולל 66 עמודים מחליף את הגרסה …
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