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CSQA and RQA Collaboration Agreement
7th September 2017The Asia QA Forum is a confederation of QA societies in Japan, Korea, China, Taiwan, Thailand, India, Malaysia and Singapore. The Forum arranges a conference every two years - RQA was invited to the 2017 Asia QA Forum 3rd International Conference in Beijing, China. On day one of the Forum Conference, on 7th September 2017, the Chinese Society of Quality Assurance (CSQA) and the Research Quality Association (RQA) signed a Collaboration Agreement that recognises the importance of mutual contribution to both parties, the industry and society. At a luncheon organised by the Asia QA Forum Council, the Research Quality Association was invited to speak in support of its application to become an Associate Member of the Asia QA Forum. Following a brief presentation, by Anthony Wilkinson, introducing the RQA and outlining what the Association could contribute to the Asia QA Forum, the Council unanimously agreed to approve RQA’s application. Accordingly, the Research Quality Association has been formally accepted as an Associate Member of the Asia QA Forum.
New recruitment Opportunity - The University of Liverpool
7th August 2017A new recruitment opportunity added to the website - Quality Assurance Manager at the Liverpool Experimental Cancer Medicine Centre (LECMC)
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
26th July 2017This is the first revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’. It extends the existing EU guidance to address first-in-human (FIH) and early phase clinical trials (CTs) with integrated protocols. The revision is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs).
PV Committee Vacancy
24th July 2017The RQA Good Pharmacovigilance Practice Committee is recruiting a new committee member. We are open to applications from all parties, but may be particularly interested in those currently employed in a biotech organisation, or those with expertise with safety databases, perhaps working in the PV-IT world. Please contact Louise Handy, the Committee Chair, on louise@handyconsulting.co.uk or pharmacovigilance@therqa.com, providing details of your experience and what you would bring to the committee as an active member.
New recruitment opportunity
12th July 2017A new recruitment opportunity added to the website - QA Manager, Charles River, France
Recruitment opportunity
12th July 2017Another recruitment opportunity added to the website - Quality Assurance Manager (part time), UCL Cancer Institute, London
Regulatory and procedural guidelines (human and veterinary)
12th July 2017This guidance specifies the technical requirements and the process of transmission of individual case safety reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the European Economic Area.
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance
5th July 2017This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request.
First ever guidance for stem cell therapies in animals published
27th June 2017Document gives advice on sterile manufacturing processes for veterinary stem cell medicines The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has approved today the first ever guidance at European Union (EU) level for stem cell-based medicines for veterinary use, in the form of a question-and-answer document prepared by the CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
FDA Announces Availability of Draft Guidance on Electronic Records and Electronic Signatures in Clinical Investigations
21st June 201720th June 2017 FDA is announcing the availability of a draft guidance for industry entitled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11-- Questions and Answers.” The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products.
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