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US company put on notice for marketing unapproved stem cell products
Arizona company claims their products can treat Lyme disease, diabetes, Parkinson’s disease and more, but have not been approved for any use.
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Regs & Legs
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‘Inconsistent’ use of antibodies found in laboratory experiments
16 May 2019 | By
Researchers say they have affirmed inconsistencies in the use of a common laboratory procedure called immunohistochemical staining.
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Drug Target Review – Issue 1 2019
In this issue: AI-driven automated chemistry as a tool to accelerate drug discovery processes, the shifting landscape of immuno-oncology, and how lipid molecules provide an insight into biological research.
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Webinar preview: Compliance with data integrity and computerised system validations
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.
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Application note: Transforming your bioanalysis operations – is a lack of insight slowing you down?
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.
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Drug Target Review – Issue 4 2018
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.
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Compliance with data integrity and computerised system validations
30 October 2018 | By PerkinElmer
During this webinar, we investigated trends seen globally for data integrity violations and avenues for remediation.
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Expert view: Tools for compliance with 21 CFR Part 11
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…
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Drug Target Review – Issue 3 2018
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.
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Drug Target Review: Our 5 Steps to GDPR Compliance
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.
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SMi’s 5th Annual Molecular Diagnostics Conference 2018 agenda released
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...
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SMi’s 13th Annual ADMET conference 2018 brochure released
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...
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Drug Target Review – Issue #1 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.
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Paediatric Clinical Trials
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...
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EMA’s building approval process in Amsterdam initiated
New permanent building to be completed by 15 November 2019...