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 [...]
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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 [...]
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 [...]
Kinapse welcomes you to ICH Q12 Back to Kinapse blog May 2020 The USFDA has recently released a presentation and recording of “ICH Q12: Overview and application to Generic drugs” as a part of a 2 day virtual webinar [...]
Kinapse welcomes you to ICH Q12 Back to Kinapse blog April 2020 On 9th April 2020, Swissmedic published an update on the implementation of ICH Q12 in Switzerland. As an ICH member Switzerland also follows the EMA in implementing [...]
Back to Kinapse blog March 2020 On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an implementation note which clearly states that the tools and concepts in the ICH Q12 guideline that are not foreseen in the EU [...]
Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine ImpuritiesKonstantina Konstantinopoulou2020-12-17T15:30:59+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 [...]
Back to Kinapse blog December 2019 Kinapse welcomes you to ICH Q12 The key milestone is reached with adoption (Step 4 of ICH process) of ICH Q12 Guideline on the Technical and Regulatory Considerations for Pharmaceutical Product [...]
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
Kinapse launches Plain Language Summary Portal Kinapse, a Syneos Health Company, a market leader in clinical trial disclosure services, announced the launch of ClinTrialDataShare.com, a web portal for sponsors to publicly share plain language summaries (layperson summaries, lay summaries, or results summaries) of clinical trials. With the aim to improve transparency of clinical [...]