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Data integrity and computerised system validations (CSV) have become an area of increased scrutiny for regulatory agencies over the last several years. Understanding how the agencies view data integrity is critical for laboratories to maintain complete compliance.
Many bioanalytical labs work with a crowded and siloed set of systems and processes. From part electronic to part paper-based workflows to standalone point-solutions, the result is a lack of insight into data and slower reporting and results handling.
In this issue: Omics-informed drug target discovery in combating emerging infectious diseases, measuring intracellular ATP levels to access compound-mediated cellular toxicity, and turning organoids into physiologically relevant high-content assays for drug discovery.
30 October 2018 | By PerkinElmer
During this webinar, we investigated trends seen globally for data integrity violations and avenues for remediation.
All computer systems that store data to make Quality decisions or data that will be reported to the FDA must be compliant with 21 CFR Part 11. The purpose of this law is to define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent…
In this issue: pharmacological targeting of mitochondrial dysfunction in Parkinson’s disease, the evolving role of three dimensional in-vitro cell culture techniques in drug discovery, and NGS: hunting mysterious ‘Dark Matter Genome’ towards rewriting the rules of genetic diseases.
The General Data Protection Regulation (GDPR) is a new set of EU rules governing how a company manages, protects and administers personal data. Whether you are a subscriber, author, advertiser or supplier to our journal, we may hold information about you and we need to keep it private and secure.
SMi proudly presents its 5th annual conference on Molecular Diagnostics, taking place at the Holiday Inn Kensington Forum, London, UK on 9 and 10 July 2018, with a half-day post-conference workshops on 11 July 2018...
The annual ADMET conference is returning to London, UK for its 13th year running and will be taking place at the Holiday Inn Kensington Forum on the 9 and 10 July 2018...
In this issue: how customised cell engineering advances immunotherapy, how insights into auto-immunity are providing new opportunities for immune-oncology, and advances in lab automation and robotics are accelerating the pace of antimicrobial therapy.
When designing a Paediatric clinical trial, a paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children...
New permanent building to be completed by 15 November 2019...
The EMA Management Board have met in an extraordinary session to discuss EMA’s future premises in Amsterdam...
Presenting issues and real-life examples within the RNA space, SMi welcome insights and discussions into new technologies for single-stranded RNA, epigenetics to develop first-in class drugs in oncology, patenting RNA Therapeutics and exploring the latest developments in delivery systems, including Exosomes and Nanocomplexes. Read on for your exclusive discount to…
Our agenda is packed with keynote addresses, expert speakers, informative content and senior figures from within the industry…read on to find out more…
