פארמה וביוטק

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New drug development and regulation from clinical trials to marketing approval

2020-08-16T12:54:06+00:00June 18th, 2020|

Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) or EU CTA (Clinical Trial Application) submission to the [...]

Medical device cleaning techniques and validation

2020-08-30T12:44:07+00:00June 18th, 2020|

The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure consistently controls potential carryover, contaminants, cleaning agents and extraneous material into the [...]

Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

2020-09-21T08:16:28+00:00June 17th, 2020|

The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, medical devices and combination products. Risk management is a [...]

OTC drugs and cosmetics regulations and good practices

2020-08-16T12:30:38+00:00December 15th, 2016|

Background and history In 1938, the Federal Food, Drug and Cosmetic Act (FFDCA) granted FDA authorization for regulation of cosmetic products and ingredients. The statutory provisions of the [...]

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