Pharma & Biotech

ההבדלים בין תעשיית הפארמה המסורתית לתחום הבריאות הדיגיטלית

2020-06-28T07:22:00+00:00ינואר 23rd, 2020|

המעבר מרפואה מסורתית לרפואה מבוססת כלים טכנולוגיים ובריאות הדיגיטלית תחום הפארמה קיים מזה מאות שנים ואף הוביל לתמורות רבות בכל הנוגע לטיפול בחולים, ריפוי מחלות, הארכת תוחלת החיים, [...]

Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

2017-11-30T10:30:55+00:00נובמבר 30th, 2017|

The medical and pharmaceutical industries are involved with new product development and manufacturing (such as medical devices & products, medicines, and combinations thereof). Risk management is a regulatory requirement [...]

New drug development and regulation from clinical trials to marketing approval

2015-05-20T07:19:52+00:00מאי 20th, 2015|

[vc_row][vc_column][vc_column_text] 1.   Background After new investigational drug pre-clinical stage 1 was completed, and IND (Investigational New Drug application) or CAT (Clinical Trial Application) submission to the FDA or CE [...]

Fermentation in the Bio-Pharmaceutical industry

2014-07-30T07:20:07+00:00יולי 30th, 2014|

[vc_row][vc_column][vc_column_text] 1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra or extra cellular metabolites that have a pharmacological effect. [...]

New drug development and regulation from pre-clinical to clinical trials

2014-07-21T07:20:03+00:00יולי 21st, 2014|

[vc_row][vc_column][vc_column_text] 1.   Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the Chemistry Department of Agriculture. Five years later, a [...]

Corrective And Preventive Actions (CAPA system)

2012-01-22T07:20:22+00:00ינואר 22nd, 2012|

[vc_row][vc_column][vc_column_text]1. Introduction "Non-conformity" investigation is very common term being used in production and product quality improvement areas in the Pharmaceutical and Medical Devices world. It is mandatory and considered [...]

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