GMP Stats Online Training 2026
Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 2 Contents Introduction Our online training courses: The UK Clinical Trial Regulations are Changing ......................................... 4 A Guide to the UK Clinical Trial Regulations 2026............................... 4 Fundamentals of GCP ...................... 5 Essential GCP for Sponsors ........... 6 GCP Refresher for Sponsors .......... 7 GCP has Changed – what’s new in ICH E6(R3) ........................................ 7 Essential GCP for Investigators .... 8 GCP Refresher for Investigators.... 9 GCP has Changed – E6(R3) for investigators ......................................... 9 The Principles of GCP ........................ 10 Are You Ready for … a GCP Inspection?.............................................. 10 Risk Management in Clinical Trials ......................................................... 10 Essential Guide to the EU Clinical Trial Regulation .................................... 11 Managing and Reporting Serious Breaches of the EU Clinical Trial Regulation ............................................. 12 CTR for ALL – a high-level overview of the EU CTR ................... 12 Clinical Investigator Site Awareness: the EU CTR ................... 12 Non-interventional Studies, General Principles................................ 13 NIS, Practical Aspects ......................... 13 NIS Essentials for Investigators ... 13 Are You Ready for … a PV Inspection?.............................................. 14 PV for ALL .............................................. 14 Essential PV – know PV................... 14 PV for the Local Safety Contact and L-QPPV ........................................... 15 PV Refresher.......................................... 15 Essential Safety Reporting for the Investigator Site .................................. 15 The Principles of the General Data Protection Regulation (GDPR) ....... 16 GCP for Clinical Data Management......................................... 16 GCP for Clinical Laboratories ......... 16 Good Manufacturing Practice ....... 17 Good Distribution Practice............... 18 Data Integrity ....................................... 19
Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 3 Brookwood has delivered training in clinical research and related areas for over 35 years, and is the preferred trainer to a large number of organizations. In addition to ‘face-to-face’ basic, advanced and update courses, Brookwood delivers a wide range of courses as webinars, virtual events and as online courses. All of our courses are kept up to date and can be customized to meet clients’ needs. We offer a fully managed service or clients can license and purchase the courses to run them on their own learning management systems. Our policy has always been to make our training interactive and relevant, engaging and activating participants as much as we can. Take a look at the exciting online courses in this brochure. Please do not hesitate to contact us should you require a bespoke course, either delivered face-to-face, as a webinar or as a customized online course on a topic not covered in this brochure. Our ICH GCP E6(R3) Investigator Site Training meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. These courses have CPD awards from the Royal Colleges of Physicians of the United Kingdom and Hungarian versions have the accreditation of the Semmelweis University (SOTE), Budapest. Why buy our training courses? • Online, on-demand. Do them anywhere! All that is needed is a strong continuous internet signal • Globally log in at any time 24/7, 365 days a year • Delivery by html 5 allows PC, laptop, iPad, iPhone and android mobile devices to be used • Tracking of user activity • Progress reporting by user and group • Certification for satisfactory completion • The training is personalized using the participant’s first name • Costs depend on the number of participants • Excellent packages for multiple users • Option to fix costs with multi-year agreements • Help in the event of problems • Valuable e-resources • Run on our LMS or alternatively purchase the SCORM files and deliver under license on your own LMS. Key: TransCelerate 4
Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 4 The UK Clinical Trial Regulations are Changing This 40 minute update course overviews the key changes to the regulations that enter force on 28th April 2026. It is ideal for anyone who is working on clinical trials in the UK, mainly those who already has a working knowledge of the UK clinical trial regulations Content includes: • Development and scope of the new regulations • Changes to definitions • Requirement for GCP compliance • The new clinical trial approval process • Modifications to the clinical trial • Transparency requirements • Pharmacovigilance changes • Short heads-up on other changes such as urgent safety measures, ethics and consent, record keeping, labelling, non-IMPs, ending a trial • MHRA Guidance. A Guide to the UK Clinical Trial Regulations 2026 This course overviews key UK Clinical trial regulations as implemented in April 2026. This includes SI 2025 No. 87, SI 2025 No.538 and the additional requirements relating to pharmacists and technicians. It is relevant for both sponsors and investigators undertaking clinical trials in the UK and assumes no prior knowledge of the regulation. The course is interactive and divided into a number of short sections. Regs Regs • ONLINE TRAINING • The courses are interactive with narrated and read only options and can be stopped and restarted at any time All of our CTR courses come with a link to our unique online bookshelf which contains useful documents relating to the CTR. This bookshelf is updated regularly and participants of courses have ongoing access to this. Certification will be completed on completion of the course. For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 5 • Needs no prior knowledge of GCP • Ideal as core basic training • This course aims to provide training on the key requirements of GCP relating to sponsors and investigators • A great course to provide basic GCP knowledge to sponsors, investigators, service providers, ethics committees and regulators • Can be used to refresh and update GCP knowledge • Takes around 2.5 hours – stop and restart at any time • Consists of 11 sections covering: – GCP Basics – Risk Assessment, critical to quality factors, quality by design – Trial site selection & suitability – The trial protocol – Requirements for ethics and informed consent – Safety monitoring and reporting – Investigational Product management – Data quality and handling, including the use of computerized systems – Trial monitoring & oversight – Requirements for service providers – Essential records – Section quizzes to test and re-inforce knowledge prior to a final test • Narrated, or read-only options • Personalized with first name, interactions to aid learning • Additional resources form part of the course including ICH E6(R3) and E8(R1) guidelines, Declaration of Helsinki 2024 and more • Pass the final test to be awarded certification • Interactions and quiz questions to maintain interest. GMP Stats GCP FLAGSHIP ONLINE COURSE Fundamentals of GCP Modern, exciting, online, on-demand course covering the Good Clinical Practice (GCP) requirements of both sponsors and the investigator site. TransCelerate 4 6
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 6 Essential GCP for Sponsors • Now updated to ICH GCP E6(R3) • Essential Good Clinical Practice for Sponsors Online Training, for those with no current GCP training, and for those needing an update and refresher • Based on the sponsor responsibilities laid down in Section 3 of the ICH GCP E6(R3) guidelines as well as some of the key investigator responsibilities • Includes a section on data handling and key points of data governance as provided in section 4 of the guideline • Covers the basics of essential records as provided in Appendix C of the guideline • Users can choose between a narrated or read-only (no sound) track • The training is divided into key sections, each with interactions GCP • Quick 50-question test at the end of the training confirms knowledge • Those who attain the 80% pass mark will receive certification • Test answers can be reviewed and the incorrect answers in the test retaken • Takes around 1 hour. What are the benefits of this sponsor training? • Online, on demand. Do it anywhere! All that is needed is a strong continuous internet signal • Globally log in at any time 24/7, 365 days a year • Delivery by html 5 allows PC, laptop, iPad, iPhone and android mobile devices to be used • Tracking of user activity, progress reporting by user and group • Certification for satisfactory completion • The training is personalized using the participant’s first name • The training is challenging and long enough to be a true training and evaluation option • Costs depend on the number of participants with excellent packages for multiple users • Fix costs with a 2-year agreement or longer • Help in the event of problems • Valuable e-resources in the course include a Guide to Consent, an Essential GCP book and a copy of the ICH GCP E6(R3) guidelines. This course complements the Essential GCP for Investigators (available in 14 languages) and the GCP Refresher for Investigators which both fulfil TransCelerate Biopharma’s minimum requirements for the mutual recognition of GCP training for investigators. TransCelerate 4 6 FLAGSHIP ONLINE COURSE For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 7 GCP Refresher for Sponsors This GCP refresher course for sponsors and service providers is an interactive quiz game with 55 questions. Takes around 45 minutes. • This course is for those who have previously undertaken comprehensive E6(R3) training and are now in need of a refresher. The course is not a substitute for basic training in E6(R3) • Questions cover a wide range of GCP topics based on ICH E6(R3) Principles and Annex I • 11 levels of slightly increasing difficulty – complete them all to pass • 5 questions at each level – must get 4 correct to proceed (80%) • Feedback given for incorrect answers, with opportunity to review and repeat the level • Compulsory ‘Did You Know?’ sections to enhance learning • Resources to read form part of the course. GCP GCP GCP has changed – what’s new in ICH E6(R3) This 45-minute online course aims to update sponsor and service provider personnel who already have current GCP training in place. It covers the new requirements introduced by the latest E6(R3) Annex 1 guideline. It emphasizes the need for a risk proportionate approach to trial management that focuses on the rights, safety and well-being of participants and the reliability of trial data. It identifies some of the trickier new requirements faced by sponsors, service providers and investigators. TransCelerate 4 4 Keep up to date with a regular newsletter dedicated to clinical research and quality assurance – Advisor Newsletter Advisor is a quick and easy to read interactive newsletter, published 20 times per annum. It provides an ideal opportunity for busy clinical research and quality assurance professionals to keep up to date with the latest news and information. ISSN 2041-367X 13 JANUARY 2025 Issue 554 Major overhaul of UK clinical trial regulations under parliamentary review New legislation has now been laid before the UK parliament to change how clinical trials are conducted in the UK. A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency – with support from partners including the Health Research Authority, academia and researchers – that will make it faster and easier to gain approval and to run clinical trials in the UK. The changes represent the biggest overhaul of the UK clinical trial regulations in over 20 years, and will help to make the UK one of the best countries in the world in which to conduct clinical research for patients and researchers. The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety. Details on page 4 u UK clinical trials performance improves but further support needed The past 2 years have seen positive change for UK industry clinical trials, and the Association of the British Pharmaceutical Industry’s annual report shows evidence of continued progress. The number of pharmaceutical industry trials initiated in the UK grew in 2023 for the second year running, and for the first time since 2017 the UK’s global rankings in late-phase clinical trial initiations improved. However, the numbers remained significantly below those from 2017 and the UK is also underperforming in the delivery of industry trials to time and target, with up to 30% not recruiting the agreed participant numbers within specified timeframes. The annual report makes six recommendations on how best to help the UK to deliver the full benefits of industry trials to UK patients, the National Health Service and the economy. Further details on page 6 u EU agencies finalise common approach to data transparency in medicines regulation On 18 December 2024, the European Medicines Agency and the Heads of Medicines Agencies adopted comprehensively revised guidance on the identification of commercially confidential information (CCI) and personal data (PD) in marketing authorisation applications for human medicines. The updated document reaffirms the commitment of regulatory authorities across the European Economic Area to extensive transparency when disclosing information, both in response to access-to-documents requests and in the proactive publication of data once a medicine is authorised. The new final guidance supersedes initial guidance on this topic from 2012, describing the agreed principles on CCI and PD, and providing recommendations on whether such information can be disclosed. See page 5 u Call for more dedicated paediatric drug research Despite multiple regulatory incentives, an examination of FDA paediatric drug approvals over a 13-year period suggests that more needs to be done to encourage the development of treatments for conditions that are unique to children. As reported in JAMA Pediatrics, between 1 January 2011 and 31 December 2023 orphan indications (for rare diseases) were more likely than non-orphan indications to be approved for paediatric use, and most non-orphan indications required the support of one of the three paediatricspecific regulatory programmes available in the USA. The researchers suggest that there is a need to plug gaps in the current regulatory process in order to maximise paediatric drug development. More on page 9 u page 2 u ISSN 2041-367X 3 FEBRUARY 2025 Issue 555 CDER report details approvals of safe and effective therapies in 2024 The FDA’s Center for Drug Evaluation and Research (CDER) has issued its ‘New Drug Therapy Approvals 2024’ report. The report highlights the work of the Center’s review teams in their thorough evaluation and approval of safe and effective therapies, resulting in multiple new medicinal products that are likely to have a significant positive impact on public health. The 2024 approvals include a significant number of new therapies for rare diseases and a record annual total for biosimilar products. The report also notes the importance of innovative regulatory approaches to help expedite drug review. See page 6 u EU rules on health technology assessments take effect The new Health Technology Assessment Regulation (Regulation (EU) 2021/2282) came into effect on 12 January 2025, and the European Medicines Agency has committed to supporting enhanced EU collaboration to allow faster and wider access to innovative health technologies. Health technology assessments (HTAs) help EU Member States to decide on the use, price and reimbursement level of new health technologies, and support them in ensuring the quality, accessibility and sustainability of healthcare. Close interaction between regulators, HTA bodies and other relevant parties is critical to enabling patient access to new treatments, for the wider benefit of public health. Details on page 4 u GCP lessons: FDA warns Polish investigator over record keeping and protocol compliance An investigator in Poland has received an FDA warning letter highlighting violations of the federal regulations during the conduct of a Phase 3 clinical study. The warning letter highlights how, on several occasions, the information provided to the FDA during the inspection was subsequently contradicted in the investigator’s written response to the inspection findings. Additionally, the inspector tried to attribute the lack of contemporaneous record keeping to internet connectivity issues resulting from the effects of the COVID-19 pandemic. However, the FDA noted that the delays in recording data took place prior to the start of the pandemic. The agency also highlighted that the times and/or dates of assessments appear to have been edited to look as if they were recorded during the assessments. Details on page 9 u page 2 u ABPI demands regulatory renewal across UK life sciences In a statement accompanying a new report issued on 4 December 2024, the Association of the British Pharmaceutical Industry (ABPI) notes that it is now time to explore how the UK pharmaceutical industry can contribute to shaping a globally leading UK regulatory framework for innovative medicines. The ABPI wants the UK to be the best place in the world to research, develop and use the medicines and vaccines of the future. In its report (entitled ‘Enhancing the Role of UK Medicine Regulation’) the ABPI explores the crucial role of regulatory excellence in driving innovation and early access, supporting patient trust and attracting investment into the UK. More on page 8 u Follow us on LinkedIn for the latest developments in clinical research, GCP and quality assurance. ISSN 2041-367X 17 FEBRUARY 2025 Issue 556 Editorial 2025 is a defining year in the regulation of clinical trials in humans. The ICH GCP guideline has been hugely changed, for the first time since its original release in 1996. The E6(R3) Guideline will define how clinical trials are to be conducted globally for years to come. Before the Step 4 (final) version of E6(R3) was released, over 7000 comments received during the public consultation on the Step 2 draft (issued in May 2023) had to be considered. This was indeed a major workload for the Expert Working Group (EWG), but the result speaks for itself and the EWG members should be congratulated. We now have a final guideline that encompasses modern trends and developments in clinical trials, such as new data acquisition tools and electronic methodologies. E6(R3) is divided into a set of overarching Principles of GCP, and guidance in the forms of Annexes 1 and 2. Annex 2 is still to be finalised. It is vital that sponsors, investigators and other stakeholders become familiar with and adhere to the Principles of GCP. These will be incorporated into some regional regulations, such as those of the UK. This issue of Advisor – written by Jane Baguley – reviews what has changed between the draft Step 2 and the final Step 4 versions of the E6(R3) Guideline, highlighting some of the key changes. We hope that you find it useful. The development of an updated GCP guideline On 6 January 2025, the ICH Harmonised Guideline ‘Guideline for Good Clinical Practice E6(R3)’ was endorsed by the Regulatory Members of the ICH Assembly under Step 4 of the ICH process. By reaching this milestone, the final draft is recommended for adoption to the regulatory bodies of the ICH regions. GCP is an international ethical, scientific and quality standard for the conduct of trials that involve human participants. Conducting clinical trials in accordance with this standard helps to assure that the rights, safety and well-being of trial participants are protected; that trial conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the results are reliable. Back in 2019 ICH noted that, in the two decades since the ICH E6 Guideline was first drafted, clinical trials had become more complex in their design, utilisation of technology, quantity of data collected and involvement of central testing facilities or other service providers. E6(R2) was issued to address the emerging use of electronic data sources and risk management processes, but clinical trials continued u page 2 KEEP UP TO DATE For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 8 Essential GCP for Investigators • Comprehensive training on investigator ICH GCP E6(R3) responsibilities • Based on the investigator responsibilities laid down in Sections 2 and 4 of the ICH GCP E6(R3) guidelines • Meets the minimum requirements for the mutual recognition of investigator GCP training laid down by TransCelerate BioPharma Inc in 2025 • Available in numerous languages including English, Japanese, Chinese, Polish, LatAm Spanish, Turkish and Hungarian • Users can choose between a narrated or read-only (no sound) track • The training is divided into key sections, each with interactions • Takes around 1.25 hour • Integral quizzes and an online multichoice test at the end of the training confirms knowledge • Those who attain the 80% pass mark receive certification • Test answers can be reviewed and the test retaken • It is recommended that participants also undertake the GCP Principles course to ensure comprehensive training in E6(R3). What are the benefits of this Investigator training? • Online, on demand. Do it anywhere! All that is needed is a strong continuous internet signal • Globally log in at any time 24/7, 365 days a year • Delivery by html 5 allows PC, laptop, iPad, iPhone and android mobile devices to be used • Tracking of user activity, progress reporting by user and group • Certification for satisfactory completion • The training is personalized using the participant’s first name • The training is challenging and long enough to be a true training and evaluation option • Costs depend on the number of participants with excellent packages for multiple users • Fix costs with a 2-year agreement or longer • Help in the event of problems • Valuable e-resources in the course include a Guide to Consent, an Essential GCP book and a copy of the ICH GCP E6(R3) guidelines. GCP For details of packages for training larger groups contact us at info@brookwood-global.com TransCelerate 4 6 FLAGSHIP ONLINE COURSE
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 9 GCP Refresher for Investigators • This course is for those who have previously undertaken comprehensive E6(R3) training and is now in need of a refresher. The course is not a substitute for basic training in E6(R3) – see our other courses if this is required • Investigator-specific questions cover a wide range of GCP topics based on ICH E6(R3) Principles and Annex I • 11 levels of slightly increasing difficulty – complete them all to pass • 5 questions at each level – must get 4 correct to proceed (80%) • Feedback given for incorrect answers, with opportunity to review and repeat the level • Compulsory ‘Did You Know?’ sections to enhance learning • Resources to read form part of the course • Takes around 45 minutes. GCP GCP For details of packages for training larger groups contact us at info@brookwood-global.com GCP has changed – E6(R3) for investigators This short online, on-demand narrated or read-only course informs investigators and other site personnel about changes to GCP brought about by the ICH E6(R3) guideline. It is aimed at those who already have current GCP training in place. The course covers the new requirements that investigators need to adopt as part of their clinical trial practices. TransCelerate 4 4 Brookwood Global have published books in clinical research and related areas for over 30 years. Our books include reference texts as well as useful best-practice guides and include the ICH GCP Guidelines, the European Clinical Trial Regulation, the Declaration of Helsinki and much more. The books are now also available as e-books and can be read on a variety of devices and computers. As a bespoke alternative, all of our books and e-books can be fully customized in your own colours bearing your corporate logo. Visit the website for our full range. www.brookwood-global.com
Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 10 • ONLINE TRAINING • GCP GCP The Principles of GCP This 30-minute course covers the overarching principles of GCP that are the key requirements to be followed in all clinical trials. It is important for everyone involved in human clinical trials whether commercial or noncommercial. It should be taken in conjunction with the other GCP courses we offer. It is especially suitable for those who do not need to know the detail of their practical implementation presented in Annex 1 and the Appendices of the E6(R3) guideline, such as administrators, coordinators and those in departments outside clinical operations. The course is personalized, interactive and has narrated and read-only options. Valuable e-resources in the course include a Guide to Consent, an Essential GCP book and a copy of the ICH GCP E6(R3) guidelines. For details of packages for training larger groups contact us at info@brookwood-global.com Are you ready for … a GCP inspection? • Online, on-demand inspection readiness training • Personalized, narrated or read-only options • Takes around 35 minutes • Highly interactive • Based on answers to a series of questions relating to inspections • Developed with those experienced in inspections and those who perform them! • Comes with a downloadable self-checklist • The training content addresses a wide range of common questions that are often asked and provides information based on experience, words of advice and practical tips. Risk Management in Clinical Trials In this 60-minute course, we look at the general principles relating to risk management in clinical trials. We utilize relevant regulatory guidance as well as the principles in ICH GCP to help you to understand the risk management process and how this is done. Content includes: • The principles of risk-based management of clinical trials • Who should be involved in a risk assessment? • Why might risks change as the trial progresses? • Identification of ‘Critical to Quality Factors’ • The steps involved in a risk-based approach to clinical trials • Setting Quality Tolerance Levels • Risks at the system and trial level • Risk mitigation • Risk-based monitoring • Case studies • Quick quiz to test knowledge • Glossary of terms. RM
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 11 Essential Guide to the EU Clinical Trial Regulation This online, on-demand course covers in more depth the main content and requirements of the EU Clinical Trial Regulation (CTR). The course is interactive and takes around 1 hour. It also contains questions as an integral part of the course to check knowledge gained. Content includes: • Structure of the CTR and supporting guidelines • The Clinical Trial Information System (CTIS) – what is it? Functionality of the CTIS • Interventional, non-interventional and low interventional trials EU CTR • Authorization of a clinical trial – a single application • Notifications and templates • Substantial and non-substantial modifications • Conditions for conducting a clinical trial • Site suitability statement • Additional informed consent requirements • Consent for vulnerable patients • Safety reporting • Serious breach reporting • Urgent safety measures • Summary of trial results • Trial Master File and document retention. All of our CTR courses come with a link to our unique online bookshelf which contains useful documents relating to the CTR. This bookshelf is updated regularly and participants of courses have ongoing access to this. For details of packages for training larger groups contact us at info@brookwood-global.com The EU Clinical Trial Regulation It is important that both sponsors and investigators are aware of the requirements of the EU Clinical Trial Regulation 2014 No 536. Our four online courses offer training: • for those needing a high-level overview • for those needing more in-depth knowledge • for investigator site members who need awareness of how the CTR changes their responsibilities and working practices. FLAGSHIP ONLINE COURSE www.brookwood-global.com info@brookwood-global.com Stats COMING SOON Our new range of courses in Clinical Statistics GMP Stats
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 12 CTR for ALL – a high-level overview of the EU CTR This 15-20 minute course is ideal for those needing a short, high-level introduction to the EU CTR. It covers the main changes to working practices and highlights some of the new important requirements. Content includes: • When the CTR applies • What the CTR brings that’s new • Heads-up on the new trial authorization process • Significant changes to trial conduct • Modifications, notifications and reports • How the CTR affects the Trial Master File. EU CTR Clinical Investigator Site Awareness: the EU CTR This short 20-minute course provides investigators and members of their team with a heads-up on what clinical trial staff need to know about the CTR. It highlights what is new and different, and what has changed from the previous EU requirements. Content includes: • Why the EU introduced the CTR • Scope of the CTR • New requirements relating to trial conduct • New consent requirements • Serious breaches and urgent safety measures • Changes to safety reporting requirements • Pre-trial information requirements • Retention of essential documents • Risk-proportionate approaches to clinical trials • Changes for the sponsor. EU CTR Managing and Reporting Serious Breaches of the EU CTR This 30-minute, on-demand course overviews the requirements of the EU Clinical Trial Regulation (CTR) and the content of the European Medicines Agency guideline relating to the management and reporting of serious breaches of the Regulation, protocol and GCP. This training is suitable for all those involved in clinical trials in humans who may encounter a serious breach, including both sponsors and investigator site personnel, whether based in Europe or elsewhere. Content includes: • What is a reportable serious breach? • Definition of serious breaches: what the key words mean • Who should make a report and when • Examples of serious and non-serious breaches • Responsibilities of vendors and investigators. EU CTR For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 13 Non-interventional Studies, General Principles Interactive, personalized, narrated and readonly tracks, suitable for both inexperienced and experienced staff. Provides a generic core basic training (takes approx. 35 minutes). Content includes: • What are non-interventional studies (NIS)? • Why perform NIS? • Definition of NIS • Declaration of Helsinki • Rules governing NIS • Data protection • Requests by regulators • PAS, PASS, PAES explained • NIS in pharmacovigilance • Pharmacovigilance inspections • Abbreviations explained • Glossary of terms • Short quiz. NIS NIS, Practical Aspects Designed around an air journey to different parts of the real world to learn about key elements of running NIS. Content includes: • Setting up and running NIS • Planning • Impact of EU and US requirements • Choosing a design • Role of SCOPE; GRACE principles • Cross-sectional, case-control and cohort studies • Protocol content and development • Declaration of Helsinki and NIS • ENCePP guidance • Study milestones • Consent in NIS • Study conduct • Analysis of data • Codes of conduct and agreements • Scientific independence • Monitoring • MAH oversight obligations • NIS and safety reports; risk management plans • Data privacy • Study report • Publication of results • Training • Documentation and archives • Glossary of terms • Short quiz. NIS NIS Essentials for Investigators This training provides an understanding of the general obligations of researchers when undertaking NIS. Topics include: • Definition of non-interventional • Types of study • Key factors affecting NIS • Ethics and consent • Health authority approval • Data privacy • Protocol and its content • Current medical practice • Safety data collection • Study contracts • Data access • Study reports • Publication of results • Glossary of terms and abbreviations • Short quiz. NIS For details of packages for training larger groups contact us at info@brookwood-global.com www.brookwood-global.com/GCP info@brookwood-global.com MD COMING SOON Our new course – GCP in Medical Device Investigations GMP Stats
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 14 Are You Ready for … a PV Inspection? This online, on-demand inspection readiness training takes around 35 minutes to complete. It is ideal for those facing a pharmacovigilance (PV) inspection, including the safety and clinical operations departments. Developed with Dr Lisbeth Tofte Hemmingsen, a well-respected PV and QA expert who has huge experience of inspections. • Based on answers to a series of questions relating to inspections • Packed with information, ‘Words of Advice’ and practical tips • Personalized, narrated or read-only options • Highly interactive • Can be done on PCs, Macs, laptops and mobile devices 24/7/365 • Comes with a downloadable self-checklist. PV PV for ALL This short online PV training is for an entire organization’s staff. It can be fully customized. Run it on your own server or let us manage it for you. Content includes: • Types of product safety information that may be encountered • Who might report safety information • How and when to report to the Local Safety Contact • Key information to be obtained. PV PV Essential PV – know PV This online training covers essential PV in more depth. It is approximately 60 minutes long and is ideal for those who need a more detailed knowledge of PV. Content includes: • What is and what governs PV • Roles and responsibilities • Key PV process steps; safety information and its capture • Product safety oversight • ADRs – basic facts, solicited v unsolicited reports • Expedited individual case safety reporting • MedDRA coding • Periodic safety reporting, PSURs, PBRERs, DSURs • Risk management planning • Safety signals • Reference safety information • PV system master file • Inspections. For details of packages for training larger groups contact us at info@brookwood-global.com We facilitate Webinars on a variety of subjects relating to clinical trials.Be sure to check the website frequently to view our forthcoming webinar events.
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 15 PV for the Local Safety Contact and L-QPPV This online training covers the responsibilities of the company’s Local Safety Contact and the additional obligations of a Local QPPV (L-QPPV). The course takes around 40 minutes and is suitable for those involved as Local Safety Contacts and those who work with them. Content includes: • Regulatory requirements and main responsibilities • L-QPPV’s role in capturing, recording and reporting local safety information and PV activities • Managing local challenges. PV Refresher An interactive Q&A game to update and refresh PV knowledge. Face five inspectors and answer 8/10 questions correctly each time to ‘pass the inspection’! Questions include a wide range of PV topics. PV All of our online courses can be customized to meet your specific requirements. Let us run them for you using our full service package of registration, tracking, reporting and certification, or run them on your own learning management system. PV PV Essential Safety Reporting for the Investigator Site This course is essential for all investigators needing to have awareness of their safety reporting obligations arising from the treatment of patients in clinical research. • Covers the basic principles of safety reporting, key regulations, guidance and best practices that apply to clinical trials and observational/non-interventional studies • Consists of presented material, ‘Did You Know?’ highlights to supplement knowledge and numerous interactions to make the learning more enjoyable • Has great resources including ICH E2A e-book, ‘Essential Pharmacovigilance’ e-book, CIOMS form and CTCAE quick reference guide for causality assessment. For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 16 For details of packages for training larger groups contact us at info@brookwood-global.com The Principles of the General Data Protection Regulation (GDPR) This 30-minute online on-demand training with a quiz and certification is an ideal way for those processing personal data to learn about the latest requirements for data protection. Content includes: • Key roles • Definitions of personal data • Applicability of the GDPR and exemptions • Consent and rights of Data Subjects • Legal basis for processing • Obligations towards Data Subjects • Risk assessment • Data transfer outside EEA • Record keeping • Data security and storage • The Data Protection Officer • Data protection ‘by design and default’ • Audits • Managing breaches, compensation and penalties • Data protection checklist • Specific content on the impact of GDPR on pharmacovigilance and clinical trials. GDPR GCP for Clinical Laboratories This 30-minute narrated course is ideal for laboratory staff needing an insight into GCLP requirements, as well as sponsors’ monitors, medical experts and auditors who utilize laboratory services in clinical trials. It is based on the guidance given in the European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012. It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply. The program also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge. GCLP GCP for Clinical Data Management This online on-demand training with a quiz and certification is a fun interactive way for data management personnel to learn about their GCP responsibilities. Content includes: • Qualifications, training, SOPs • Computerized systems • Data flow and source data quality • Data collection, quality and management • Documentation • Using CROs • Risk register and risk-based approaches • GCP checklist for clinical data management. CDM
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 17 This Good Manufacturing Practice (GMP) online course is aimed at new starters and existing staff as part of their induction and/or ongoing GMP training. The Royal Society of Chemistry (RSC) Approved GMP online course provides a detailed overview of why we have GMP and what GMP is in three core chapters, with additional chapters covering specific GMP requirements for different parts of the site. To achieve certification each participant must complete the three core chapters and one role-specific chapter, which can be selected from the drop-down list of available options. Additional chapters can be purchased as an extra by choosing the additional chapter required from the list of related products shown. GMP Good Manufacturing Practice Core chapters The core chapters shown below are available as either a UK or non-UK version. The UK version has references to the UK’s regulatory authority (the MHRA) and its ‘Orange Guide’, whereas the non-UK version does not. Chapter 1: An introduction to the pharmaceutical industry This chapter provides an overview of the pharmaceutical industry and the need to regulate medicines manufacture and supply. Duration: 10–15 minutes Chapter 2: An introduction to Good Manufacturing Practice This chapter introduces the concept of Manufacturing Authorisations for sites and Marketing Authorisations for medicines, and the need for GMP at sites making pharmaceuticals. Duration: 10–15 minutes Chapter 3: The Good Manufacturing Practice guidelines The main content and requirements of the nine chapters of EU GMP are explained and why these are important. Reference is also made to the additional requirements in the Annexes of EU GMP. Duration: 15–20 minutes Additional chapters These are specific for different parts of the site – please choose one from the following depending on which area you work in. Chapter 4: GMP in the warehouse Chapter 5: GMP in manufacturing Chapter 6: GMP in packaging Chapter 7: GMP in the laboratory Chapter 8: GMP for engineering personnel Chapter 9: GMP for QA personnel This course has been approved by the RSC For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 18 This Good Distribution Practice (GDP) course targets new hires as well as current employees needing ongoing or refresher GDP training. It explains why GDP exists, what it entails and its key requirements. The course is approved by the Royal Society of Chemistry (RSC). The course consists of the following chapters. Chapter 1: An introduction to the pharmaceutical industry This chapter provides an overview of the pharmaceutical industry and the need to regulate medicines manufacture and supply. GMP Chapter 2: An introduction to Good Distribution Practice This chapter introduces the concept of Wholesale Dealer Authorisations and the need for GDP. Chapter 3: The GDP guidelines The main content and requirements of the 10 chapters of GDP are explained and why these are important. Chapter 4: Working to GDP The key elements of GDP are covered, with a special focus on what GDP means for the individual working for an organization involved in the storage, transport and/or brokering of medical products. Good Distribution Practice This course has been approved by the RSC These chapters are available either as a UK or non-UK version. The UK version has references to the UK’s regulatory authority (the MHRA) and its ‘Green Guide’, whereas the non-UK version does not. Each chapter has a series of randomly selected assessment quiz questions at the end. An 80% pass mark is expected. Guidance is provided if a delegate gets an answer wrong. After successful completion of the course, a certificate including the RSC ‘Approved Training’ logo is available for download by the delegate. For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 19 Data Integrity Data integrity is currently a major focus area during regulatory inspections. It is therefore essential that your team have the correct understanding of what is required. This online data integrity course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. This 20-minute online data integrity course will give you and your team a clear understanding of your role in meeting the expectations of European inspectors and the FDA. GMP Course content • What is data integrity? • Why it is important • The ALCOA principles for paper-based, computer-based and hybrid systems • Application of the ALCOA principles • ALCOA+ update • The importance of metadata • Positive Quality Culture • Assessment At the end of the online data integrity course there is a series of randomly selected assessment quiz questions. An 80% pass mark is expected to successfully complete the course. Guidance is provided if a delegate gets an answer wrong. Once you have completed the course you will be able to print a certificate including the RSC ‘Approved Training’ logo. This course has been approved by the RSC The course is based on the guidance given in the European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012. It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply. The program also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge. For details of packages for training larger groups contact us at info@brookwood-global.com
Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 20 5 Studley Court Mews, Chobham, Surrey GU24 8EB, UK Tel: +44 1483 811383 Email: info@brookwood-global.com Web: www.brookwood-global.com
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