The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. The range of activities spans individuals providing ad hoc advice to the outsourcing of the entire suite of critical pharmacovigilance processes and governance roles via licensing or marketing authorisation holder partners, vendors for services or tools, and individual contractors. Whilst the majority of service providers offer a valuable and compliant support to marketing authorisations holders, the MHRA GPvP Inspectorate experience is that marketing authorisation holders do not always include adequate text in written agreements to allow management of the outsourced activities and the risk of serious pharmacovigilance failures.
An update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union
A roundup of links on the EMA relocation decision can be found here.
The 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.
A new recruitment opportunity added to the website - Quality Assurance Manager at the Liverpool Experimental Cancer Medicine Centre (LECMC)
This 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).
The 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 firstname.lastname@example.org or email@example.com, providing details of your experience and what you would bring to the committee as an active member.
A new recruitment opportunity added to the website - QA Manager, Charles River, France
Another recruitment opportunity added to the website - Quality Assurance Manager (part time), UCL Cancer Institute, London
This 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.
This 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.
Document 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)
20th 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.
The EMA Board discussed the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portals go-live date has been postponed.
Welcome to our new website. We would appreciate any feedback you may have. Please send an e-mail to firstname.lastname@example.org with your comments.
Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017 The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.
Key principles and working methodology established The European Medicines Agency (EMA) organised an information meeting yesterday with members of its Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA Member States. The goal was to start discussing how the work related to the evaluation and monitoring of medicines will be shared between Member States in view of the United Kingdom’s (UK) withdrawal from the European Union.
18 May 2017 | GENEVA - Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.