Konstantina Konstantinopoulou

About Konstantina Konstantinopoulou

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So far Konstantina Konstantinopoulou has created 19 blog entries.

KASA system

2020-12-03T16:30:12+00:00

KASA System FDA’s regulatory assessment has evolved from a summary-based review to a question and risk-based review with an integrated quality assessment. Over the years, the FDA has focused on the challenges of efficiency, consistency, and objectivity in its oversight of pharmaceutical quality. To [...]

KASA system2020-12-03T16:30:12+00:00

The Value of Patient Voices in Plain Language Summaries Webinar

2020-12-07T09:51:24+00:00

Plain language summaries (PLSs) aim to meet a need in the industry for clinical trial transparency in a way that is meaningful and understandable for patients and the general public. As the pharmaceutical industry steps up to meet this requirement, patient panels play a crucial role in ensuring that information shared by sponsors [...]

The Value of Patient Voices in Plain Language Summaries Webinar2020-12-07T09:51:24+00:00

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

2020-12-07T09:35:36+00:00

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Summary: The USFDA recently finalized the guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products”. This guidance addresses repackaging of prescription and [...]

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products2020-12-07T09:35:36+00:00

US Agent & Official Correspondent (OC) Services

2020-12-07T09:53:14+00:00

US Agent & Official Correspondent (OC) Services Are you planning to register and market your pharmaceutical, medical device or food and dietary supplement in the US? Do you have a US agent? All non-U.S. Food, Beverage, Dietary Supplement, Medical Device or Drug companies who [...]

US Agent & Official Correspondent (OC) Services2020-12-07T09:53:14+00:00

Kinapse provides expert standalone document quality control services

2020-12-07T09:53:33+00:00

Back to Kinapse blog Kinapse provides expert standalone document quality control services The number of clinical trials as well as the amount of regulatory documentation required for each trial is increasing. The production of high quality documents within strict timelines is therefore resource intensive and demanding. By [...]

Kinapse provides expert standalone document quality control services2020-12-07T09:53:33+00:00

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines

2020-12-07T10:11:32+00:00

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines In 2018, the European medicines regulatory network became aware of the presence of N-nitrosamines in sartan APIs and instituted a series of regulatory actions across the EU, including recalls of some medicines [...]

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines2020-12-07T10:11:32+00:00
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