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 [...]
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 Konstantinopoulou2020-02-14T14:22:30+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 [...]
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 [...]
Learn why requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risks for sponsors.