This year’s RQA Annual Conference, held in Leeds was attended by over 300 delegates and many attendees visited the ADAMAS stand in the exhibition hall. The Poster by Dr Annie Chen, ADAMAS Consultant “Conducting remote vendor audits” proved extremely popular and repeat...
About ISCR Conference Indian Society for Clinical Research has announced its 8thAnnual Conference, to be held during February 13-14, 2015 at Hotel Leela Ambience, Gurgaon. In keeping with the conference theme, 'Clinical Research in India - Towards Achche Din' the main...
Transparency within Clinical Trials – The new EU Regulation and Stakeholders chance to provide opinions The new European Clinical Trial Regulation (536/2014) introduces a degree of transparency into information relating to clinical trials performed within EU member...
On 25-Apr-14, the MHRA issued a press release indicating that the definition of a critical GCP inspection finding had been changed. It now includes ‘Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily...
India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a decade. However, the recent changes to regulations, although intended to safeguard patient rights and ethics, has...
The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) (TMF) for management, audit and inspection of clinical trials was 30 April 2013. The draft paper included several recent...
Source data is being collected utilizing electronic methods. This is seen at a site (for example via electronic medical records) but also subjects are being asked to provide data electronically. This could include an interactive voice/web response system or even...
Two new GVP modules were published in December 2012, Module III - Pharmacovigilance Inspections and Module IV - Pharmacovigilance Audits, bringing the total of final modules to nine. It is expected that the remaining modules will be finalised and published in 2013....
Come and meet ADAMAS Consulting at the RQA International QA Conference, Brighton
Enhancing Good Pharmacovigilance Practice with ADAMAS Consulting
DIA 2024 Global Annual Meeting | San Diego, CA
Come and meet ADAMAS Consulting at the RQA European QA Conference, Belfast
Computer Software Assurance (CSA): Why the Change and What Does it Mean?