Recent News
If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
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A Pharmaceutical Quality Webinar for Global Stakeholders
23rd September 2020A Pharmaceutical Quality Webinar for Global Stakeholders Held: 23rd July, 2020
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COVID-19 EMEA - Life Sciences Survey
16th September 2020What measures have EMEA governments taken in the life sciences sector to fight COVID-19?
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EMA - Big Data Steering Group workplan for 2020-21
16th September 2020The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020-21.
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MHRA - Investigations in the GMDP environment
16th September 2020A blog by Callum McLoughlin.
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Make it Public: transparency and openness in health and social care research
3rd September 2020Why research transparency is important The UK has a thriving health and social care research environment. More people take part in research studies each year, and donations to medical research charities are on the rise. Health and social care research findings translate into better care for patients and service users, and improvements to our health and wellbeing. They also lead to economic growth. Scientific and medical publishing has become more open over recent years and new initiatives are driving towards research findings being ever more freely available. This is making research findings more accessible to researchers and others working in health and social care. However, the people who take part in research studies want to know about the findings of research too. Transparency about what research is going on, and what its findings are, is important for patients, service users and the public. It builds trust and accountability, acknowledges their contribution and encourages participation in research. It’s also essential for research and care professionals. It leads to improvements and avoids duplication of effort. It enables findings to be used to develop new and better treatments for patients and service users, and to identify the best ways for us to stay healthy and well. It also helps improve the quality of research. When research is carried out openly and transparently, everyone benefits: patients and the public can see what research is taking place or has completed, and access clear information about the results patients, service users and carers can find out about research that is relevant to them, giving them the opportunity to join studies health professionals, commissioners, researchers, policy makers and funders can use research findings to make informed decisions
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ARSAC notes for guidance: good clinical practice in nuclear medicine
2nd September 2020Guidance on licencing and best use of radiopharmaceuticals and sealed radioactive sources in diagnosis, treatment or research.
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EU: Checklist for Brexit Preparation
2nd September 2020The end of the transition period is approaching and no agreement is in sight. Having first published a Communication to prepare for the end of the transition period, the European Commission has now published a respective 'Brexit Readiness Checklist' for companies doing business with the UK. This checklist is designed to help EU companies doing business in the UK (United Kingdom; UK) and/or UK companies doing business in the EU to check exactly how well prepared they are for 1 January 2021.
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MHRA - Brexit Transition
2nd September 2020Guidance for industry and organisations to follow from 1 January 2021 issued by the UK Government.
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MHRA - Changes from 1st January 2021
2nd September 2020The MHRA have released lots of documents relating to Brexit and the changes that will need to implemented on 1st January 2021 so it is worth taking a look at their news area.
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MHRA - List of approved countries for authorised human medicines from 1 January 2021
2nd September 2020Approved countries for batch testing and importation of medicines from 1 January 2021
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MHRA - preparing to make submissions to the MHRA from 1 January 2021
2nd September 2020Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems to use from 1 January 2021.
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Helping you navigate the world of medical device regulation
27th August 2020Oxford Global Guidance Helping you navigate the world of medical device regulation A digital tool to make it easier to understand how medical device regulations apply to your product.
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RQA News - JSQA / RQA Collaboration Pharmacovigilance Quality Systems
27th August 2020Members Only Both Japan and the European Union have highly advanced and defined legislation and regulatory expectations for pharmacovigilance. JSQA and RQA have previously collaborated on an overview document for all pharmacovigilance requirements. In this collaboration an analysis of EU and Japan Quality Management Systems (QMS) to support pharmacovigilance as described in legislation and guidance documents is presented. In this collaborative exercise we provide a comparison of these requirements.
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RQA News - PV Legislative Update
27th August 2020Members Only August 2020 Version
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MHRA - Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
19th August 2020Graeme McKilligan During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities. Requirements and expectations have been refreshed with Inspectors with a particular focus of attention on sites handling products with lower level Health Based Exposure Levels (HBELs), those with products around the red area of the continuum seen in the PIC/S Q&A document,
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OECD - Draft Guidance Documents on Good Laboratory Practice (GLP) for public comments
19th August 2020On 07 August 2020, the OECD made OECD Draft Advisory Document on GLP Data Integrity for public comment.
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PIC/S publishes Aide-Memoire for the Inspection of Health Based Exposure Limit
19th August 2020In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) issued the new document PI 052-1. What is in it?
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Guidance for industry on MHRA’s expectations for return to UK on-site inspections
11th August 2020The MHRA are planning to resume on-site UK risk-based GxP inspections in September.
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International Standard For Medical Device Testing Updated
4th August 2020ISO 14155:2020 - Clinical investigation of medical devices for human subjects — GCP Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.
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MHRA - GCP Serious Breaches update
4th August 2020The annual metrics report for GCP referrals has now been published for 2019. In 2019, MHRA received a total of 112 serious breach notifications, of which: 75 were deemed to be a serious breach 36 deemed not to be a serious breach 1 awaiting further information to enable final determination...
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
29th July 2020EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.
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RQA NEWS - GLP news pages updated
28th July 2020The GLP News pages on the website have been updated today.
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EMA consultation: Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6
23rd July 2020The European Medicines Agency has published for public consultation for a concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6.
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MHRA planning for return to on-site Good Practice (GxP) inspections
23rd July 2020Starting in September, MHRA is making careful preparations for a safe return to normal UK on-site inspection scheduling.
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China - Guiding Principles for the Preservation of Prepared Documents
22nd July 2020China - Circular of the State Food and Drug Administration on Issuing the Guidelines for the Preservation of Essential Documents for Drug Clinical Trials
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EMA published for public consultation on a draft access policy: Union Product Database Access Policy (UPD) - Veterinary Medicinal Products.
22nd July 2020Veterinary stakeholders are invited to comment on a draft access policy for the Union Product Database, which will provide information on all authorised veterinary medicines and their availability in EU Member States. The access policy sets out the types of information different user groups should be allowed to access once the database becomes operational in January 2022. Implementation of the Union Product Database is required by the new Veterinary Medicines Regulation. For more information, see Implementation of the new Veterinary Medicines Regulation. Stakeholders should submit comments on the access policy to vetchange.programme@ema.europa.eu by 18 September 2020.
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First edition of the Veterinary Medicines Regulation Highlight
22nd July 2020First edition of the Veterinary Medicines Regulation Highlight - July 2020
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Pharmacovigilance Audits and Inspections during COVID-19
22nd July 2020The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes Q&As relating to pharmacovigilance.
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MHRA - A Practical example of applying Quality Risk Management in GDP – Transportation Risks
15th July 2020What is your biggest GDP risk? If you had to think about the answer, then it is likely that you haven’t given it much thought. Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation....
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Medical devices given exceptional use authorisations during the COVID-19 pandemic
14th July 2020List of manufacturers and their medical devices which have been granted an exemption by the MHRA
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020
14th July 2020At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
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International regulators provide guiding principles for COVID-19 clinical trials
6th July 2020EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA).
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Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008
2nd July 2020Changes to the Q&A published in May 2020.
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QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC
2nd July 2020QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC - Update to Q&A document released by EMA, EC and HMA. Updated 1st July 2020.
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MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'
30th June 2020Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors (Gail Francis, Steve Vinter and Andy Fisher) and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
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EMA - Academia fee waiver for scientific advice
23rd June 2020The EMA is pleased to inform you about the decision to waive all fees for scientific advice for academic researchers developing orphan medicines, to further encourage the development of treatments for rare diseases.
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EMA - Pharmaceuticals – safe and affordable medicines (new EU strategy)
23rd June 2020About this initiative: Summary The EU is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. It will address: • the life cycle of medicines from R&D to authorisation and patient access • how to put scientific and technological advances into practice • how to fill market gaps (e.g. new antimicrobials) • lessons learnt from COVID-19 on how to better prepare for future pandemics. Topic: Public health Type of act: Communication Category: Commission Work Programme
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Have your say on the future development of ISO 9000 and ISO 9001
23rd June 2020The current editions of ISO 9000, Quality management systems Fundamentals and vocabulary, and ISO 9001, Quality management systems Requirements, were published in 2015. Both standards will shortly be up for a systematic review as required by the ISO Directives. The choices available for what happens to the standards are: Confirm, Revise/Amend, Withdraw, or Abstain.
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ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS
23rd June 2020Remote auditing is one of the audit methods described in ISO 19011:2018 Annex A1. The value of this audit method resides in its potential to provide flexibility to achieving the audit objectives. In order to realize the benefits of this audit method, all interested parties should be aware of their role in the process, inputs, expected outputs, and risks and opportunities that will provide the basis to achieve the audit and audit program objectives.
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Survey assessing the Member States’ rules on health data in the light of GDPR
23rd June 2020Request for comments from EMA.
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Opportunities for patients and the public to be involved in the work of the MHRA
17th June 2020How the MHRA engage and involve patients and the public in our regulatory decision-making. Updated 15th June 2020.
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Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
17th June 2020FDA/CTTI Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice - meeting materials
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Good Clinical Practice Symposium 2020
16th June 2020Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. This included individual events from the GPvP, GCP and Laboratories Inspectorates where a host of regulators and delegates from across the globe came together.
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Guidance on remote GCP Inspections - 10th June 2020
15th June 2020Guidance on remote GCP inspections during the COVID19 pandemic This document is intended to provide guidance on the steps to be followed during remote good clinical practice (GCP) inspections.
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ICH E6(R3) Good Clinical Practice workshop with Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties
15th June 2020A virtual workshop on the renovation of the ICH guideline on Good Clinical Practice E6, further to the discussions during the March 2020 PCWP/HCPWP Joint meeting. Presentations available.
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Meeting highlights from the PV Risk Assessment Committee (PRAC)
15th June 2020At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
3rd June 2020As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-level meeting of regulators from around the world on 27 May 2020 to discuss COVID-19 policies, regulatory aspects of COVID-19 medicine development and pragmatic approaches to address challenges posed by the ongoing pandemic.
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MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK
3rd June 2020MHRA has today given the first positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for use of Gilead’s remdesivir.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
3rd June 2020Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.
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Good Laboratories Practice Symposium 2020
1st June 2020Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. This included individual events from the GPvP, GCP and Laboratories Inspectorates where a host of regulators and delegates from across the globe came together.
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DRAFT DOCUMENT FOR COMMENTS: GMP water for pharmaceutical use
27th May 2020Open for comments, deadline 30th June 2020.
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Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices
26th May 2020Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term or pre-existing conditions.
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EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials
19th May 2020The European Medicines Agency (EMA) has published a notice for sponsors of clinical trials (CTs) to highlight the requirements for the qualification and validation of computer systems used for managing CT data. This is based on recent inspection findings and takes into account implications on the integrity, reliability, robustness and acceptability of data. In line with this notice, the EMA has also updated questions 8 and 9 on EMA´s GCP Q&A website, which provide further guidance on computerised systems.
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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
19th May 2020The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues and pharmacovigilance in light of the medical emergency presented by COVID-19.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020
19th May 2020PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy
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OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING
19th May 2020Number 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
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MHRA: How to manage temporary GDP process changes and risks through the COVID-19 pandemic
14th May 2020Terry Madigan, 13th May During the Covid-19 pandemic you may need to adjust how you operate, for example using temporary process deviations and temporary staff. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles as described in the EU Guidelines on Good Distribution Practice for finished products.
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MHRA: Patient Support Programmes
14th May 2020Kiernan Trevett, Posted on:7 May 2020 - Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.
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MHRA: Using personal data in your business or other organisation during and after the transition period
14th May 2020What you should do when transferring people’s personal data between the UK and the EU/EEA.
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Safety Observer - COVID-19 Update Now Available
14th May 2020Clinical Safety & Pharmacovigilance Regulatory Intelligence Review
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MHRA: How tests and testing kits for coronavirus (COVID-19) work
13th May 2020The MHRA has released information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits....
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COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
5th May 2020As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible.
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Good Pharmacovigilance Practice Symposium 2020
5th May 2020The Good Pharmacovigilance Practice (GPvP) Symposium 2020, held on 11 February in London and attended by 380 delegates, launched the weeklong series of events led by the Inspectorate as part of the MHRA Good Practice Symposia week.
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 April 2020
1st May 2020CVMP adopts concept paper on environmental risk assessment for parasiticide veterinary medicinal products used in companion animals CVMP opinions on veterinary medicinal products
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Notice to sponsors on validation and qualification of computerised systems used in clinical trials
1st May 2020Note: This notice should be read in conjunction with Q8 and Q9 from the good clinical practice (GCP) Q&As published on the EMA website: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinicalpractice/qa-good-clinical-practice-gcp
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Coronavirus: EC issues guidance to mitigate clinical trial disruption
28th April 2020Today, the European Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic.....
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Delayed implementation of MDR
27th April 2020The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.
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MRC Regulatory Support Centre COVID-19 Bulletin
27th April 2020The COVID-19 pandemic has significantly impacted health research as it has every aspect of our lives. In this bulletin we pull together information about the special research governance arrangements currently in place to help tackle the pandemic. Many of these arrangements will be temporary.
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Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak
22nd April 2020These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
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EMA - Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20th April 2020The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.
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Pharmacovigilance Inspection Metrics April 2018 to March 2019
20th April 2020The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019. The full metrics report is available on GOV.UK.
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MedDRA Version 23.0 Update to be Produced
15th April 2020The ICH MedDRA Management Committee has decided to provide the new COVID-19 terms within the MedDRA dictionary in a very expedited fashion, given the current very exceptional time with the COVID-19 pandemic demanding flexible approaches to ensure that any scientific and medical information from the COVID-19 outbreak can be captured, shared and analysed appropriately.
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Guidance on regulatory requirements in the context of the COVID-19 pandemic
14th April 2020The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.
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MHRA New opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.
14th April 2020Guidance on coronavirus (COVID-19) tests and testing kits - updated with new opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.
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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
10th April 2020Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
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CVMP Draft Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
10th April 2020Deadline for comments 30th April 2020
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Pharmaceutical and diagnostics industries are already responding to Governments call to arms
9th April 2020We can first ensure that testing is available for patients who need it, then expand testing of critical NHS staff and their families, followed by testing critical key workers, and then the community as a whole. The plan includes a national effort for diagnostics, to build mass testing capacity at a totally new scale. We did not start this crisis with a large diagnostics industry, so instead we are going to have to build one.
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Conduct of remote Investigator Site Audits (ISAs) - Guidance
8th April 2020TMQA have produced this document on the conduct of remote ISAs.
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MHRA - Flexibility in GxP Labs
8th April 2020Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak
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Process Licensing Update
3rd April 2020A blog post by Asif Janjua, Posted on:3 April 2020, to give an update on a change to how the MHRA are issuing their licences and certificates due to the coronavirus pandemic; and a reminder to keep your contact details up to date.
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EMA Regulatory Science to 2025
1st April 2020EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed. The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary. The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.
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Advice for Good Laboratory Practice facilities in relation to coronavirus (COVID-19)
31st March 2020MHRA Blog Entry: It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.
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Health Research Authority (NHS) - News
31st March 2020Important updates about health research during the COVID-19 pandemic.
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Links from COVID-19 Webinar held on 31st March 2020
31st March 2020Please find the links from the recent webinar on COVID-19, held at 1pm (BST) on 31st March 2020.
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