About Konstantina Konstantinopoulou

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So far Konstantina Konstantinopoulou has created 21 blog entries.

Kinapse provides expert standalone document quality control services

2021-06-17T16:19:38+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 services2021-06-17T16:19:38+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

Conferences

2020-07-16T15:50:53+00:00

Conferences and Workshop Presentations Creating Meaningful Phase 1 PK Lay Summaries Speaker: Vidhi Vashisht CBI Lay Summary Summit, Sep 2018 General Data Protection Rule: What is in for Redaction and Anonymization Speakers: Pooja Phogat and Shalini Dwivedi DIA Medical Writing India Chapter, Aug 2018 CBI Clinical [...]

Conferences2020-07-16T15:50:53+00:00

Overview of the new drug regulation registration (DRR) in China

2020-12-07T10:11:21+00:00

Overview of the new Drug Regulation Registration (DRR) in China On the 1st July 2020 the new Drug Regulation Registration (DRR) will be implemented in China. There are a number of significant changes within this new regulation covering new marketing applications, clinical [...]

Overview of the new drug regulation registration (DRR) in China2020-12-07T10:11:21+00:00

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities

2020-12-17T15:30:59+00:00

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities The deadline to respond to EMA Art. 5(3) Referral on NITROSAMINES is fast approaching. MAHs are obliged to submit the conclusions of risk evaluations for all of their medicinal products containing [...]

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities2020-12-17T15:30:59+00:00

Writing Plain Language Summaries for Clinical Trials Webinar

2019-12-06T11:00:08+00:00

Join this free webinar to learn how the pharmaceutical industry is engaging with patients and patient advocates to gain feedback and produce high-quality plain language summaries. When Friday December 06th 9 am EST | 2pm GMT | 3pm CET | Register

Writing Plain Language Summaries for Clinical Trials Webinar2019-12-06T11:00:08+00:00
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