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Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, the internet is transforming the way these protocols are communicated to a global audience. Medical writers can use data visualisation to represent study schemas in protocols as infographics and in this way help readers to better understand multiple layers of complex information. Study schemas can be designed using standard tools such as Microsoft PowerPoint. Medical writers can use visual elements such as colour, shapes, and icons to portray timelines, dosage regimens, treatment arms, study periods, and procedures. This article describes key concepts in data visualisation and demonstrates how those concepts can be applied in designing creative, effective, and informative study schemas. [ABSTRACT FROM AUTHOR]

The article discusses the European Union (EU) Clinical Trials Regulation 536/2014 (CTR) which will facilitate sponsors' clinical trial application in EU, while streamlining the assessment and supervision processes for regulatory authorities. Topics include the challenges in the transition from the Old Clinical Trials Directive to the EU CTR, the drive to better inform and involve patients, and the commitment of European Medicines Agency (EMA) to stimulating innovative clinical research.

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as "public disclosure-ready" as possible. It has potential to increase the quality of final CSRs and enhance consistency within and between sponsors. The ever-burgeoning regulatory guidance document substructure contains content requirements mandated subsequent to the International Council for Harmonisation (ICH) E3 guidance that must be worked into CSRs; these are integrated into CORE Reference. It is also the only known freelyavailable resource that pinpoints the sections in an ICH E3-compliant CSR that are potentially affected by public disclosure considerations. Two years on from its initial release in May 2016, the developers of CORE Reference review the growing utility of this important tool, and place it into the context of the current global era of increasing data transparency and disclosure, where policies and guidelines in development beyond European borders will further mandate carefully authored CSRs for sharing in a global public arena. [ABSTRACT FROM AUTHOR]

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available in publications due to reporting bias found in literature. At present, CSRs are the only documents that are comprehensive enough to solve this problem. Developments being carried out by the EMA and journal editors towards data transparency may place CSRs as future core documents. [ABSTRACT FROM AUTHOR]

As of October 2016, EMA publishes clinical data on their clinical data website (https://clinicaldata.ema.europa.eu). This new procedure applies to all marketing authorisation applications submitted by pharmaceutical companies under the centralised procedure to the EMA. Before publication of the documents in scope, companies have to ensure that personal data of trial participants and personnel as well as commercially confidential information is protected. This article describes the challenges for sponsors to implement and maintain efficient and up-to-date processes that also take into account the multitude of transparency requirements of other channels, such as ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

EMA Policies 0043 and 0070 allow access to a broad range of regulatory documents. This article compares the two policies, highlighting key differences relevant for medical writers and professionals focussing on clinical data transparency. This article then summarises Teva's experience with implementing Policy 0070 and preparing the company's first two Policy 0070 dossiers for publication. Finally, the article reviews major challenges and how to overcome them, for example, how to consider previous Policy 0043 requests for the same drug product. Medical writers need to become familiar with these policies because the increased dissemination of regulatory documents will affect how these are prepared in the future. [ABSTRACT FROM AUTHOR]

In 2015, the EMA Policy 0070 came into effect as part of EMA's commitment to increased data transparency. In short, clinical reports included in regulatory applications for example, marketing authorisations are published on the EMA web page and thereby made publicly available. Before the clinical reports can be published, the applicant is required by legislation to protect personal data to ensure individual clinical study participants and other individuals involved in the study are not identified. The applicant has to describe how data protection of personal data has been ensured in an anonymisation report (AnR). This article describes the different steps necessary to prepare an AnR in general, a company's first experience of preparing an AnR for an orphan drug, and the key points learned from this experience. [ABSTRACT FROM AUTHOR]

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of anonymisation in each package and the rationale for these methods. As of December 31, 2017, 64 ARs have been published on the clinical data website of the European Medicines Agency. A preliminary high-level analysis of these reports was performed, with the aim of gaining information on the current industry practices in anonymisation and AR preparation. After excluding 12 ARs from packages that did not contain protected personal data, 52 ARs were analysed. Information on anonymisation methodology, re-identification risk assessment, data utility assessment, and use of software is presented. [ABSTRACT FROM AUTHOR]

Recently, the EMA released the revised Module V - Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU - in integrated format. The revision will result in concise, scientifically focussed and riskproportionate documents and is applicable to all sections of the RMP, especially sections that have become overly lengthy over time and often duplicate information presented else - where in the dossier or in other documents, such as the periodic safety update report. [ABSTRACT FROM AUTHOR]

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency's Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to collect data on approved products. NI PASS study reports should be drafted according to a particular mandated format, which may not be intuitive for writers more familiar with clinical study reports for interventional trials. This article addresses the structure of NI-PASS reports, comparing and contrasting with the clinical study reports of interventional trials. [ABSTRACT FROM AUTHOR]

The article focuses on European Medicines Agency (EMA)and its aim of ensuring transparency of its processes and decisions. It discusses balancing by EMA of data protection against transparency. It mentions the plan Risk Management Plan (RMP) public summary(Part VI.2), which was introduced with Good Pharmacovigilance Practices (GVP) legislation in 2012 to provide patients with information for a specific medicine in a language suited to their needs, and details of Revision 2 of GVP module V.

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have played this safe by using heavy content redaction (covering up identifying information with a blue box), but now EMA is encouraging anonymisation over redaction to help maximise data utility while simultaneously mitigating the risk of patient identification. (Anonymisation involves changing identifiers, but they are still readable, such as placing an age of 27 into a band of 20-29). This article explores the issues and considers companies' options. [ABSTRACT FROM AUTHOR]

This section offers news briefs from the European Medicines Agency (EMA). These include changes introduced by EMA to the templates of the product information that accompany all medicines authorized for use in the European Union, EMA's publication of the video recording of its webinar held on June 24, 2015 and the obligation of companies to use electronic application forms provided by EMA for centralized marketing authorisation applications for human and veterinary medicines.

A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a step-by-step approach, the medical writer is led through the RMP template with the aim of taming this mystical beast. [ABSTRACT FROM AUTHOR]

The article offers updates in the European Medicines Agency (EMA) in 2014. EMA releases an illustrated leaflet which explains how the European regulatory system for medicines operates. EMA updates its procedural guideline to ensure that marketing-authorisation holders are prepared in submitting periodic safety update reports. The agency announces changes to the procedures for scientific advice.

The article offers news briefs related to the European Medicines Agency (EMA) as of December 2014. It mentions that the EMA need marketing-authorisation holders to update the information on medicines. It states that the sponsors has to post-clinical trial results in the European Clinical trials Database (EudraCT). It mentions that the Management Board of the EMA has delayed the adoption of the policy on publication of clinical trial data.

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of general strengthening of pharmacovigilance procedures. Interventional PASS will largely adhere to International Conference on Harmonisation requirements, but non-interventional (NI) PASS should be reported according to a particular mandated format, which may appear strange to writers used to drafting clinical study reports for interventional trials. Given their novelty, there is no consensus as to how these reports should be drafted. This article addresses the structure of NI-PASS reports and provides an interpretation, albeit preliminary, of the corresponding European Medicines Agency guidance text. [ABSTRACT FROM AUTHOR]

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising each other's evaluations (the so called decentralised and mutual recognition procedures). It is a system that has evolved over the past half century from one with wholly separate national systems to one where EU countries now harness their regulatory and scientific expertise to harmonise and improve the evaluation of medicines across Europe. Today, the purely national procedure is rarely used by applicants and only when they seek marketing authorisation in a single Member State. Although the different procedures may give an impression of complexity, they have simplified the authorisation process across Member States, reducing the times for new medicines to obtain marketing authorisation and improving patient access to new medicines. [ABSTRACT FROM AUTHOR]

The global population is ageing, but inequalities remain in older people's access to treatment, especially people 75 years of age and older. These people receive less frequent interventions and lower quality medical treatment than their younger counterparts. Explanations for these inequalities include ageism, a lack of testing of medicines in older people, unclear diagnoses resulting in hesitancy to institute treatment, polypharmacy, and a general lack of concordance and compliance. In Europe, responsibility for improving this situation lies with the pharmaceutical industry, the European Medicines Agency, national regulatory agencies, prescribers, dispensing pharmacists, and the patients or consumers themselves. Clinical trial and health economic data are needed to assure the effective and safe treatment of older people. [ABSTRACT FROM AUTHOR]

Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights of patients involved in the studies, and commercial confidentiality concerns of the trial sponsors. In response to an increasing number of formal complaints about restrictive practices in publicising clinical data, the European Medicines Agency has started an initiative to enable access to patient-level study data. In November 2012, they organised a workshop to bring the stakeholders together to discuss and establish the way forward. [ABSTRACT FROM AUTHOR]

In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the 'scientific part of the application' structured according to the EMA's PIP guideline. The PIP should summarize relevant background information on the disease and drug, and use this to justify a paediatric development programme that covers the entire paediatric population. Depending on the type of drug and the relevance of the disease to the paediatric population, specific quality, safety, and/or efficacy measures may be proposed for all or part of the population. If measures are considered inappropriate for all or part of the paediatric population, then a waiver may be proposed but must be justified. If the paediatric development programme cannot be completed before submission of the adult application, then a deferral of the paediatric measures may be proposed but again this must be justified. In any case, a detailed timetable has to be provided and adhered to for any all measures being proposed. The main challenges for medical writers when writing a PIP are application of the guidance to the drug and disease in hand, and obtaining the appropriate input from the project team. [ABSTRACT FROM AUTHOR]

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized products under certain circumstances. In principle, the application needs to be submitted early in the development (before completing basic Phase I studies in adults), which may require an innovative and creative approach to the drafting of the necessary documents. The aim of this article is to provide a guide on already existing and available help and advice, to provide further suggestions and comment, and to illustrate common mistakes; the reader should then be able to increase the chances of a more rapid procedure with a higher probability of a positive outcome of the procedure. [ABSTRACT FROM AUTHOR]

The article offers world news briefs related to medical as of December 1, 2016. Topics mention including the launch of the public consultation on the revised guidance regarding the development of new medicines for the treatment of tuberculosis (TB), published reports from the European Union agency European Medicines Agency (EMA) regarding on the experience gained during the pilot project on adaptive pathways and the new guidelines on good pharmacovigilance practices (EU-GVP).

The article offers news briefs related to the European Medical Writers Association as of 2015. The EMWA has released two draft good practice guides for improving the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the Europe. The clinical development plans submitted to the European Medicines Agency (EMA) were not suitable for future benefit-risk assessment. The EMA agreed the policy on publication of clinical trial data.

The article offers news briefs related to the European Medicines Agency (EMA) as of September 2014. EMA has revised operations for some of its evaluation procedures for human medicines which include administrative procedures. A public consultation best practice guidance was published by EMA for health technology- assessment (HTA) bodies. The publication of the Clinical Trials Regulation in the Official Journal of the European Union (EU) is welcomed by EMA.

The article offers updates in the European Medicines Agency (EMA) in 2014. The EMA reviews all comments received regarding its draft guideline on publication and access to clinical trial data. The EMA and the U.S. Food and Drug Administration (FDA) establish a new cluster on pharmacovigilance topics. EMA will consider extending the application of the eSubmission Gateway and web client to all referral procedures, veterinary medicine submissions, and paediatric submissions.

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and inconsistencies regarding the PIP document. In the USA, the Food and Drug Administration Safety and Innovations Act (FDASIA) has effectively made it mandatory to submit a paediatric study plan (PSP, the US equivalent of a PIP) soon after completion of phase II of development. Drug companies will need to work out how best to manage having two approved plans in parallel and avoid discrepancies. [ABSTRACT FROM AUTHOR]

The article reports on the recommendation by the European Medicines Agency to grant a marketing authorisation for Ocrevus in the European Union for the treatment of relapsing multiple sclerosis (MS) and early primary progressive multiple sclerosis. Topics include multiple sclerosis, the clinical trials that demonstrated the effectiveness of Ocrevus in reducing the relapse rate of MS, and common adverse reactions of Ocrevus.

The article focuses on the periodic safety update report (PSUR) repository developed by agency for protection of public and animal health through supervision of medicines European Medicines Agency in collaboration with European Union (EU) Member States and industry. It discusses the single storage platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. It mentions its introduction by the EU pharmacovigilance legislation.

The article focuses on the review started by agency for protection of public and animal health through supervision of medicines European Medicines Agency (EMA) of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. It discusses the review being done in cooperation with the European Commission and Member States of the European Union (EU). It mention the need for improving safety of human volunteers in trials.

The article offers information on PRIME (Priority Medicines) scheme of European Medicines Agency (EMA) supporting medicines which aim for unmet medical need. Topics discussed include condition that needs to be met by medicine to be accepted by PRIME such as its potential of benefiting patient needs based on clinical trials data, posts selection the agency organises a meeting with Committee for Medicinal Products for Human Use (CHMP) and regulatory toolkit for medicines.

In this article the author opines that patient narratives are a critical area where medical writers and editors need to remember and apply the guidance of the European Medicines Agency (EMA) Policy 0070. Topics include the recent European Medical Writers Association workshop, Patient Data Protection in the Clinical Trial Disclosure Era, in which attendees were reminded to include only the amount of data needed.

An introduction to a section of the journal is presented which includes articles on topics including regulatory public disclosure (RPD), RPD Special Interest Group (SIG) of the European Medical Writers Association and methods of anonymisation used in European Medicines Agency clinical report.

The article reports that the vast majority of investigator brochures lack sufficient information to systematically appraise the strength of the supporting preclinical findings as per investigation of 109 investigator brochures (IBs) reported in an April 2018 issue of the journal "PLoS Biology." Topics include the IBs covered 8 of 12 therapeutic areas as distinguished by the European Medicines Agency.

The article reports that in the 2 years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical needs.

The article reports that the European Medicines Agency and its European and international partners have strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers as per the International API inspection programme report for 2011-2016. Topics include APIs stated to be responsible for the activity of a medicine, and the report focusing on the activities carried out by the U.S. Food and Drug Administration, and World Health Organization.

The article reports on the recommendation of the European Medicines Agency (EMA) regarding the contraindication of using the prostate cancer medicine known as Xofigo with Zytiga and prednisone or prednisolone due to an increasing risk of fractures and death with this combination.

The article reports on the recommendation of the European Medicines Agency (EMA) for an immediate suspension and recalling of multiple sclerosis medicine known as Zinbryta (daclizumab beta) following several reports of serious inflammation brain disorders.

The article reports on the publication of a new tool published by the European Medicines Agency (EMA) which shows the milestones and deliverables regarding the Agency's relocation from London to Amsterdam.

The article reports on the revised guidelines for the clinical studies in medicines which targets the Alzheimer's disease adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The article reports on the landmark rulings delivered by the General Court on February 6, 2018 for the European Medicines Agency (EMA) regarding its approach to transparency.

The article reports on the marketing authorisation granted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to the first class medicine known as Hemlibra (emicizumab). Topics mention including preventing bleeding episodes in patients with haemophilia A with factor VIII inhibitors, development of inhibitors and cogulation function of factor VIII inhibitors.

The article reports that the European Medicines Agency will relocate its headquarters to Amsterdam, Netherlands from London, England, following the decision of the Great Britain to withdraw from the European Union.

The article reports on a joint action plan published by the European Commission's Directorate-General for Health and Food Safety and the European Medicines Agency (EMA) for the development of advanced therapy medicinal products (ATMPs). A definition of ATMPs is given, along with its significance for severe, untreatable, or chronic diseases. Examples of the actions in the plan are outlined.

The article offers information related to medical writing, particularly on health authority briefing documents, which are documents prepared by a pharmaceutical company to support its interactions with health authorities. It discusses basic principles and the diversity of types of briefing documents, which are rarely purely clinical documents. The European Medicines Agency is mentioned.

The article focuses on the European Medicines Agency's (EMA's) conclusion of its reviewing human factor VIII medicines which shows that there is same level of risk regarding production of inhibitors between the two classes of factor VIII medicines.

The article reports that the European Medicines Agency (EMA) is inviting public comments on a reflection paper regarding development of medicines for older people as of January 2018.

The article discuses the The Joint Interagency Antimicrobial Consumption and Resistance Analysis report on antibiotic consumption and antibiotic resistance from the European Food Safety Authority, the European Medicines Agency, and the European centre for Disease Prevention and Control.

The article focuses on the revision of guidelines formed by European Medicines Agency (EMA) for the first-in-human clinical trials and mentions the impact of the guidelines on the medicine development, the safety of the participants, and management of the risks associated with the clinical trials.