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Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice.
Covering Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice, there has been significant stakeholder interest in the development of the guide. MHRA received over 1300 comments from industry, and trade and professional groups across all GxPs during the consultation process. Such a high degree of engagement required an extended period of review by the MHRA’s GxP data integrity team formed from their GCP, GDP, GLP, GMP and GPvP inspection groups. The GxP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.
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