Advisor 469
CR & CQA Advisor issue 469
ISSN 2041-3661
5 OCTOBER 2 0 2 0
EMA reports on virtual ICH E6(R3) GCP workshop
MHRA issues guidance on new rules following the Brexit transition period The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a collection of new guidance documents detailing how the industry and other organisations will need to operate from 1 January 2021, following the end of the Brexit transition period. The topics covered in the guidance include the registration of clinical trials for investigational medicinal products, the publication of summary results, substantial protocol amendments, pharmacovigilance procedures, the Qualified Person for Pharmacovigilance and importing investigational medicinal products. According to the Association of the British Pharmaceutical Industry, the guidance is similar to that published in 2019, but more detail is needed to ensure that companies can adapt successfully to the significant changes in the regulatory environment from 2021. Find out more on page 5 u
The European Medicines Agency (EMA) hosted a virtual workshop on the revision of the International Council for Harmonisation (ICH) GCP Guideline (E6(R3)) in June and issued a meeting report at the end of August 2020. The workshop highlighted the key areas that could be addressed in the revision: more patient involvement; openness to electronic informed consent; more informative consent; running clinical trials to assist decision making, by ensuring the reliability of results via a well-designed and well-articulated protocol; focusing on what is really important to the quality of the trial and participant protection; and avoiding complexity and overinterpretation. The report indicates that old habits and approaches will need to be ‘unlearned’, and replaced with new ones that support trial participants and the collection of patient-relevant data. See page 3 u The COVID-19 pandemic continues to have a huge impact on the conduct of clinical trials across the globe, with disruption to almost every aspect of clinical research. The need to ensure continuity in ongoing trials and to enable the initiation of new studies – both generally and on COVID-19 – is obvious but challenging. The Clinical Trials Transformation Initiative (CTTI) is leading several efforts aimed at helping all those affected to move forward, focusing on participant safety and minimising the impact on data integrity. The CTTI has recently released details of eight best practices for conducting trials during the COVID-19 pandemic. Details on page 7 u CTTI shares best practices for conducting trials during COVID-19
GCP lessons: MHRA reports critical data integrity finding during investigator site inspection The latest UK Medicines and Healthcare products Regulatory Agency (MHRA) annual GCP inspections metrics report describes 17 investigator site inspections completed during the 12 months to 31 March 2018. On average each inspection had five findings, but although there was just one critical finding across all the inspections, 11 (65%) of the 17 inspected sites had at least one major finding, representing a small increase in the percentage of sites with critical or major inspection findings compared with the previous 12-month period. The critical inspection finding related to data integrity issues associated with how visual analogue scale data were generated by patients and subsequently handled, primarily by the site. Learn more on page 9 u
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STOP PRESS – global news
Filing email communications in the TMF New guidance is available on handling emails generated during a clinical study. The guidance was published by the Trial Master File (TMF) Reference Model, which is managed by the Drug Information Association Document and Records Management Community. The TMF Reference Model aims to address issues relating to the TMF as described in the International Council for Harmonisation E6 GCP Guidelines. The 21-page guidance document (published on 31 July 2020) provides new recommendations on managing email communications throughout a clinical study. The topics covered include • best practices • responsibility for filing emails • handling email attachments and threads • periodic review • email archiving and preservation The FDA has issued draft guidance to help sponsors design and analyse studies evaluating the impact of impaired renal function on the pharmacokinetics (PK) of investigational drugs. The new draft provides updated recommendations on the following: • when a dedicated PK study in participants with impaired renal function is recommended • the design and conduct of PK studies in those with renal impairment • characterising a drug’s PK in patients undergoing intermittent or continuous dialysis • the analysis and reporting of data from studies that characterise the impact of renal impairment and how these data inform dosing • using PK data from Phase 2 and 3 studies to inform dosing recommendations for patients with renal impairment. The 3-month comments period ends on 3 December 2020. Source:
NIH establishes research network on emerging infectious diseases The US National Institute of Allergy and Infectious Diseases (NIAID) has created the Centers for Research in Emerging Infectious Diseases (CREID), a global network to investigate how and where viruses and other pathogens emerge from wildlife and cause diseases in people. “The impact of the COVID-19 pandemic serves as a potent reminder of the devastation that can be wrought when a new virus infects humans for the first time,” said NIAID Director Anthony S. Fauci. “The CREID network will enable early warnings of emerging diseases wherever they occur, which will be critical to rapid responses.” Each centre in the network will collaborate with peer institutions in the USA and 28 other countries, on research projects including • identifying previously unknown causes of febrile illnesses in humans • identifying the animal sources of viral or other disease- causing pathogens • determining genetic or other changes that enable these pathogens to infect humans. Each centre will also have a geographical focus, and each will be poised to study any newly emerging “pathogen X”. Source:
• regulatory expectations and citations. Source:
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STOP PRESS – global news continued
FDA committed to regulatory oversight of coronavirus vaccines Stephen Hahn and Peter Marks have jointly authored a short ‘FDA Voices’ article (dated 11 September 2020) describing the agency’s scientific and regulatory oversight of vaccines in the context of the coronavirus pandemic. The article notes that the FDA is “committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making”. The FDA’s expectations for the development of COVID-19 vaccines – including clinical trial design, and safety and efficacy considerations – are provided in the guidance document ‘Development and Licensure of Vaccines to Prevent COVID-19’. The guidance also outlines when the agency might consider an emergency use authorisation for a COVID-19 vaccine. The short article repeatedly states the agency’s commitment to being guided by science and data, perhaps acknowledging the pressure it is under to expedite the authorisation of COVID-19 vaccines. Source:
The virtual half-day workshop on 3 June 2020 aimed to gather the views of European patients, healthcare professionals and clinical researchers on clinical trials and applying GCP. The key issues discussed at the meeting and described in the meeting report (published on 28 August 2020) are outlined below. The ICH has initiated the revision of the current E6 GCP Guideline to ensure that in the future it can address the increasing diversity of clinical trial designs and data sources, and the different contexts in which clinical trials can be conducted. E6(R3) will also highlight how GCP principles can be satisfied in a variety of ways. The ICH is committed to engaging stakeholders in the revision process, in particular patient
representatives and academic clinical researchers, to ensure that the final guideline will be appropriate for everyone conducting or participating in clinical trials. The EMA is coordinating the stakeholder engagement process – of which the workshop was part – on behalf of the ICH in Europe. Revision Unlike for E6(R2), the E6(R3) revision will involve a complete rewrite and reorganisation of the current guideline. The aim is to provide • a document describing the overall principles applicable to all clinical trials, ie. that patient safety prevails over scientific and society interest, informed consent is needed, and data should be reliable
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u • two key annexes, one for interventional trials and one for non-traditional interventional clinical trials, including those incorporating real world data sources. The revision will aim to avoid overinterpretation and to focus on key concepts such as quality by design, risk-based approaches, proportionality and critical to quality factors. Wider engagement Currently, no patient or healthcare professional organisations are involved in the ICH, although the ICH would welcome an international patient organisation and an international healthcare professional organisation as official ICH observers in the future. In the meantime, through a series of engagement steps with identified stakeholders, it is hoped that the guideline will be responsive to the needs of those conducting or participating in clinical trials. Survey The Clinical Trials Transformation Initiative survey gave stakeholders an opportunity to provide feedback to the ICH’s update of E6; 60% of respondents were in the EU. The detailed results are already available and indicate that the broad areas requiring the most focus are those related to sponsors (monitoring), essential documents and investigators. The need for flexibility, simplification and updating to accommodate changes in research conduct and technology, as well as to clarify terms and concepts, was also highlighted. The results show a demand for transparency and inclusiveness, with clear requests for the inclusion of a wide variety of stakeholders in the review process and transparency around the creation of the renovation. Expert Working Group The workshop presentation by the ICH E6(R3) GCP Expert Working Group noted that more needs to be done to increase the number of patients engaged in the design of trials. In particular: • informed consent forms (ICFs) are getting longer and less comprehensible to the layperson;
guidance is needed on how patients can confirm they understand the information and agree to trial participation • study endpoints may not be those that are most important to patients • mobile phones and wearables that are part of patients’ daily lives could be better used for data collection • participants are often burdened with numerous tests, some of which may not support key trial endpoints and require increased visits • trials should be more patient-centric with, for example, some visits happening in the patient’s home. Patient organisations are keen to contribute to E6(R3). This is critical as it will be important to explain all the changes to patient organisations and to patients in general. The revision provides an opportunity to define a global standard on patient engagement in clinical trials. Investigator perspective The meeting highlighted that investigators want increased patient safety and reduced bureaucracy in clinical trials, particularly with respect to safety reporting, the comprehensibility of ICFs and regulatory ambiguity. Improvements in ICFs will only happen if patient organisations are involved in their writing. Concerns were also raised about the tendency of sponsors and contract research organisations to over-interpret GCP guidelines, which impacts the initial aim of optimising patient safety. More clarity about how, who, where and when to implement recommendations would be helpful, eg. by having abbreviated guidelines running alongside the revised full version. Non-commercial organisations The European Clinical Research Infrastructure Network is a non-profit organisation that supports certain types of multinational trials in Europe. During the workshop it reported on the challenges faced by non-commercial organisations as a result of changes in trial design and data use relating to • personalised medicine research u page 5
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• the secondary use of data • complex trials • a risk-based approach.
• proportionality and added value in relation to monitoring and source data verification • interaction between the ICH and international patient and healthcare professional groups • simplifying consent and providing guidance on the use of electronic informed consent • involving more than one investigator and/or institution in the treatment of a single patient • including patients in trial design and the review of patient information • increasing the participation of elderly patients in clinical trials (eg. through the use of new technologies). Copies of the workshop presentations are available online. MHRA issues guidance on new rules following the transition period The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a collection of guidance documents detailing the rules on medicines and medical devices that must be followed from 1 January 2021. From 1 January 2021, the MHRA will be the UK’s stand-alone medicines and medical devices regulator. The UK will offer fully independent regulatory decisions for devices and pharmaceuticals, both nationally and in joint work with other international regulators. Stakeholders need to be ready for the new rules and the MHRA has issued a collection of guidance documents on medicines and medical devices for the industry and other organisations. The guidance also covers product licensing, clinical trials, pharmacovigilance procedures, and importing medicines and investigational medicinal products. Source:
Oncology trials The European Organisation for Research and Treatment of Cancer (EORTC) explained the perspective of a non-profit cancer clinical research organisation, noting that E6(R3) should be approached as a patient topic and not as a medicines issue, and should cover the entire continuum from (early) drug development to applied clinical trials. The revision is seen as an opportunity to re-engineer a holistic continuum of research from innovation through to therapeutic strategy, rather than separating the two. EORTC suggested some challenging changes, including the following: • ensuring that changes to GCP are driven by the diversity of clinical trials and clinical questions rather than by the regulatory industry model • considering how participants in clinical research could ‘unlearn’ what has been done before and do things differently, creating completely new concepts • using the available resources to “raise quality not documentation” • refocusing on the intention of informed consent and providing alternative ways of achieving consent • changing how protocol amendments are implemented • encouraging remote and proportionate monitoring • reducing bureaucracy by limiting data collection, including reduced serious adverse event reporting. Discussion topics Other topics discussed included the following: • debate on and harmonisation in the compensation of clinical trial participants • involving ethics committees in writing E6(R3), particularly to ensure that the requirements add value and are proportionate • enabling larger clinical trials to involve a wider participant population • training patients
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All the documents are available on the MHRA website and are dated 1 September 2020. They will be updated as necessary over the coming months and are categorised under the following headings. Clinical trials • Registration of clinical trials for investigational medicinal products (IMPs) and publication of summary results • Guidance on substantial amendments to a clinical trial Pharmacovigilance • Guidance on pharmacovigilance procedures • Guidance on Qualified Person responsible for pharmacovigilance including pharmacovigilance system master files Paediatrics • Procedures for UK Paediatric Investigation Plan • Completed paediatric studies – submission, processing and assessment • Format and content of applications for agreement or modification of a PIP and requests for waivers or deferrals and concerning the operation of the compliance check Licensing • Conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice • Registering new packaging information for medicines • Guidance on the handling of applications for centrally authorised products (CAPs) pending on 1 January 2021 • How marketing authorisation applications referred under Article 29 will be handled • Converting parallel distribution notices to UK parallel import licences Devices • Regulating medical devices
• Handling of active substance master files and certificates of suitability • Reference medicinal products • Converting CAPs to UK marketing authorisations, ‘grandfathering’ and managing lifecycle changes • Renewing marketing authorisations for medicines • Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products • Guidance on licensing biosimilars, advanced therapy medicinal products and plasma master files • Comparator products in bioequivalence/ therapeutic equivalence studies Importing and exporting • Importing medicines on an approved country for import list • Exporting active substances manufactured in Great Britain for use in European Economic Area and Northern Ireland • Importing IMPs into Great Britain from approved countries • List of approved countries for authorised human medicines • Acting as a Responsible Person (import) • Applying for a Certificate of Pharmaceutical Product IT systems • Registering to make submissions to the MHRA • Webinars: preparing to make submissions to the MHRA ABPI response On 1 September 2020, the Association of the British Pharmaceutical Industry (ABPI) indicated that UK companies will welcome the important detail included in the guidance, which will support them in planning for the end of the transition period. However, the ABPI noted that the latest u page 7
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guidance includes some additions relating to the situation with Northern Ireland and a more time-restricted acceptance of EU batch testing and release. The ABPI will continue to seek more engagement with the UK government in these areas. Richard Torbett (Chief Executive of the ABPI) said, “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS [National Health Service] from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.” The ABPI added that companies are still waiting for the MHRA to provide additional technical u
information on issues such as • the handling of decentralised and mutual recognition procedures • how variations to marketing authorisations will be handled • new assessment routes • detailed guidance on the regulation of medicines in Northern Ireland. Even with the new guidance, pharmaceutical companies will face a significant change in the way they operate and will have to work through the practicalities of implementing the requirements. The MHRA will need to be available to work through the detail on an individual-company basis, given the complexity of medicines regulation.
Source: < ://tinyurl.com/y2w698j4>,
CTTI shares best practices for conducting trials during COVID-19 The Clinical Trials Transformation Initiative (CTTI) has published a set of best practices help researchers adapt to the changing clinical trial landscape and conduct successful studies during the pandemic.
The CTTI, a public–private partnership co-founded by Duke University and the FDA, seeks to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Recognising the huge impact of the COVID-19 pandemic on the conduct of clinical trials, the CTTI is considering ways to help the industry (and therefore patients) to move forward. The CTTI has conducted a series of initiatives to help the research community deal with the challenges associated with adapting trials during the pandemic, and has captured eight best practices in a new document, ‘Best Practices for Conducting Trials During the COVID-19 Pandemic’. The CTTI gathered experiences and learnings via
public surveys and discussions, and communicated these findings during two CTTI-hosted webinars. The new best practices document includes detailed information on how stakeholders can best integrate these important recommendations into their ongoing clinical trials. It also refers to and provides links to several additional resources to fully support these efforts, most notably to the ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency’, which was most recently updated on 2 July 2020. Keep participants informed The FDA guidance introduced in response to the pandemic notes that, “It is critical that trial
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u participants are kept informed of changes to the study and monitoring plans that could impact them”. The CTTI survey highlights the importance of communicating effectively with trial participants and acknowledges that patient organisations can assist in reviewing modifications, broader outreach and guidance. It is important to consider how participants view “safety” and their ability to participate in a trial in the context of the pandemic, as well as their concerns about a trial being paused or stopped. Participants’ needs change over time so these issues should be reassessed regularly. Ongoing risk–benefit assessment Participant and research personnel safety takes priority over data integrity concerns, so the aim should be to maintain safety while minimising the risks to trial integrity. The CTTI recommends a risk–benefit assessment for all studies. It outlines a three-tier system for making decisions on how to conduct ongoing and new research and directs readers to Question 1 in the Appendix of the ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency’ (“What are some of the key factors that a sponsor should consider when deciding whether to suspend or continue an ongoing study or to initiate a new study during the COVID-19 public health emergency?”). Remote study visits Useful guidance is provided on how and when remote site visits may be performed, and the steps both participants and site personnel need to take to ensure that such visits are effective and compliant. The document also describes alternatives for planned safety assessments and the collection of endpoint data, when they cannot be conducted via telephone or video calls. Communication Institutional review boards (IRBs) can help sponsors and sites to ensure that their research remains ethical, valid and compliant, but the document notes that IRBs are currently receiving an unprecedented volume of changes to ongoing research. The document outlines which study changes require IRB
review and which do not, and notes that the US regulations allow immediate changes to be made in certain situations. Recommendations on informed consent are also provided. Adjust study starts and enrolment The document acknowledges that the impact of the pandemic on new and ongoing clinical trials has been highly variable and will continue to be so. The CTTI document recommends keeping participants informed about the risks of site visits and the precautions being taken to reduce these. A list of common precautionary measures that should be implemented is provided, most of which will already be familiar to study staff and participants. Remote monitoring Existing drivers for the move towards risk-based and remote monitoring have undoubtedly been reinforced by the pandemic. The FDA has issued guidance to help expand the availability and capability of non- invasive remote monitoring devices to facilitate patient monitoring during COVID-19, and the CTTI document makes several recommendations on the implementation of remote risk-based monitoring. Critically, in all cases, any change to an existing monitoring plan must be documented. Flexibility New levels of flexibility are needed to accommodate workforce issues, remote working, changes to study monitoring, different systems and platforms, different ways of performing study assessments, remote participant screening and changes to the informed consent process. The clinical trial environment, which has historically changed rather slowly, has seen unprecedented changes since March, highlighting the importance of flexibility. COVID-19 tags All changes implemented in response to the COVID-19 pandemic should be identified and documented. The CTTI document recommends the use of a “COVID-19 tag”– a standard template for recording items such as missed assessments – and clear procedures for documenting and communicating changes.
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GCP lessons MHRA reports critical data integrity finding during investigator site inspection GCP inspections of investigator sites performed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) from 1 April 2017 to 31 March 2018 revealed a single critical finding. As described in the MHRA’s annual metrics report for the 12-month period, a total of 17 investigator sites were inspected and the emphasis of each inspection was on how the investigator site had been overseen by the sponsor/ contract research organisation. Across the 17 inspections, one (5.9%) had a critical finding and 11 (64.7%) had at least one major finding. The total number of findings and the number of findings per inspection are summarised in Table 1. will also be useful in other regions, where they should be considered alongside relevant local national or regional regulatory requirements and legislation, including • the European Medicines Agency’s (EMA’s) ‘Guidance on the Management of Clinical Trials Table 1 . Investigator site inspection findings (1 April 2017 to 31 March 2018). Guidance The CTTI document repeatedly references additional information in the applicable FDA guidance and is focused on the USA. However, the recommendations
during the COVID-19 (coronavirus) Pandemic’ (Version 3, 28 April 2020) • the Medicines and Healthcare products Regulatory Agency (MHRA) guidance on manging clinical trials during coronavirus.
Source:
Overview Overall, the inspection findings for investigator sites fell into 14 of the 42 listed categories, compared with 24 in the previous 12 months. Major inspection findings were in seven of the 42 different categories. The only category with more than one major finding was case report forms/ source data (with eight findings); the other six findings were all in different categories: data integrity, investigational medicinal product management/pharmacy, medical oversight by the principal investigator, pharmacovigilance, protocol compliance, and staff delegation and responsibility. Critical finding There was one critical inspection finding identified during an investigator site inspection undertaken as an associated site for a commercial sponsor organisation. The finding related to data integrity. The visual analogue scale (VAS) scores used as part of the exploratory endpoint for the trial could not be reconstructed. The scores were supposed to be generated by the patient using a tablet device after they had logged in, with a paper back-up available if the device was not functioning. In most cases both the paper document and the device had been populated, and there were significant differences between the scores. For example, in one case • there was no documentation to explain why there were three different scores for the same data point or which was the true source • time was not recorded on the paper form, which meant that it was not possible to determine which entry was generated first • the score was entered as 36 on the device but written as 60 on the paper document, and when measured was 62 • most of the paper sheets had not been signed by the patient but 80% had been signed by the investigator, so it was not possible to verify who had completed them • of the 60 examples checked by the inspectors, one match was found between the device and paper entries where the patient had entered 100 (maximum) on both.
Type of finding
Number of inspection findings
Mean number of findings/ inspection
Maximum number of inspection findings
Critical Major Other
1
0.1 0.8 3.8 4.7
1 3 6
14 65 80
Total
Not applicable
Compared with the previous 12-month period, there were fewer inspections (17 versus 24) and a small increase in the percentage of sites with critical or major inspection findings. However, for both major and other inspection findings, there was a decrease in the total number of inspection findings, the mean number of inspection findings per inspection and the maximum number of inspection findings compared with the previous 12 months,
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u Further data integrity issues were associated with the way in which the VAS data were collected and handled: • the audit trail of the tablet only captured the results once all three VAS assessments at the visit had been completed • the patient could change their score at any point until the finish button was pressed on the final confirmation screen; any changes before this were not recorded in the audit trail • the tablet displayed the numerical value of the point at which the patient marked their score and could be changed, therefore potentially biasing the scaled assessment • the final scores used to measure the primary outcome were calculated from the raw data by the sponsor’s statistics department, and these scores were not given to the site New EU framework to ensure ‘preparedness’ of paediatric trials The European Medicines Agency (EMA) has released the final version of a framework for paediatric clinical trial preparedness. The 22-page document (dated 31 August 2020) provides guidance on the principles of good preparation, and approaches to preparing plans and trials. The document defines trial preparedness as “a structured assessment of the key factors that could increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan”. The document argues that paediatric trials are a special case. Paediatric drug development plans and individual clinical trials can be difficult to perform for many reasons, and the number of eligible paediatric patients is often limited. As a result, timely trial completion is often difficult and paying particular attention to study design is critical. Trial conduct is often improved iteratively, and the perspectives of participants, parents/carers and patient advocacy groups can make significant contributions to optimising trial design, increasing patient retention, and reducing protocol amendments, delays and further expenses. However, such perspectives are not always included at the planning stage. The framework document notes that the research community needs to • develop strategies to improve site selection and management • tackle critical trial practicalities such as the location of sites and traveling costs • disseminate good practice • promote transparency about results and preparation. Source:
Principal Author & Editor: Prof David Hutchinson Senior Contributor: Jane Baguley Production Editor/Writer: Sharon Jordan Senior Correspondents: Fabio Camarri, Mark Elsley, Hideki Fujiwara, Lisbeth Tofte Hemmingsen, Peter Marks, Stuart McCully, ColinWilsher Aim To provide news and information to allow clinical research and quality assurance professionals, trainers, regulators, academics and members of ethics committees to stay up to date with clinical research and good practice developments. Scope Executive summaries of key laws and guidelines relating to clinical research in the ICH regions. Summaries of relevant articles and information in other publications, press releases and information on the Internet. Information on: • changes in regulations, codes of practice, guidelines and new clinical research procedures • news from important meetings and conferences • ICH developments and progress • news, views and opinions about ICH GCP implementation • solutions to compliance-related problems • inspection findings and lessons to be learnt • clinical research methodology, statistical and legal issues • quality assurance issues and procedures • self- and independent audit practice • training courses, jobs and other opportunities. Sources of information • We gather news from correspondents and other sources around the world. • We gather intelligence from those actively involved in the regulatory process. • We review the major medical, clinical research and QA journals. • We search the web and regularly visit the websites of the major regulatory authorities in Europe, the USA and Japan, pharmaceutical industry and professional associations, major academic organisations and health associations. • Sources of information, current at the time of publication, are usually quoted at the end of each article. Published by: Brookwood Global (Canary Ltd), 5 Studley Court Mews, Chobham, Surrey GU24 8EB, UK Telephone: +44 1483 811383; Fax: +44 1483 812163 Email: info@brookwood-global.com; website
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