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Objective: While many medical practitioners value the interactive nature of in-person conferences, results of these interactions are often poorly documented. The objective of this study was to pilot the Delphi method for developing consensus following a national conference and to compare the results between experts who did and did not attend., Methods: A 3-round Delphi included experts attending the 2023 Society of Disaster Medicine and Health Preparedness Annual Meeting and experts who were members of the society but did not attend. Conference speakers provided statements related to their presentations. Experts rated the statements on a 1-7 scale for agreement using STAT59 software (STAT59 Services Ltd, Edmonton, Alberta, Canada). Consensus was defined as a standard deviation of ≤ 1.0., Results: Seventy-five statements were rated by 27 experts who attended and 10 who did not: 2634 ratings in total. There was no difference in the number of statements reaching consensus in the attending group (26/75) versus that of the nonattending group (27/75) ( P  = 0.89). However, which statements reached consensus differed between the groups., Conclusion: The Delphi method is a viable method to document consensus from a conference. Advantages include the ability to involve large groups of experts, statistical measurement of the degree of consensus, and prioritization of the results.

Competing Interests: Competing interests S.L., A.D., H.S. and K.S. are Directors at The Company of Biologists and serve on the committee of The Company of Biologists Sustainable Conferencing Committee. S.L. is the Meetings Officer for the British Society for Developmental Biology (BSDB). H.S. is the honorary Vice President of the Fisheries Society of the British Isles (FSBI).

How a letter addressing the lack of women invited to speak at a conference in brain stimulation encouraged researchers to take action., Competing Interests: KH, BF, AB No competing interests declared, (© 2021, Hoy et al.)

The role of surgery in the locoregional management of many solid tumors has long been established. For testicular cancer, the incorporation of lymphadenectomy has played an important part in generating long-term survival outcomes in excess of 90% for germ cell tumor patients. In this review, we address several clinical scenarios in which lymphadenectomy at times is underutilized, and others ill advised., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The global health burden of chronic kidney disease is rapidly rising, and chronic kidney disease is an important risk factor for cerebrovascular disease. Proposed underlying mechanisms for this relationship include shared traditional risk factors such as hypertension and diabetes, uremia-related nontraditional risk factors, such as oxidative stress and abnormal calcium-phosphorus metabolism, and dialysis-specific factors such as cerebral hypoperfusion and changes in cardiac structure. Chronic kidney disease frequently complicates routine stroke risk prediction, diagnosis, management, and prevention. It is also associated with worse stroke severity, outcomes and a high burden of silent cerebrovascular disease, and vascular cognitive impairment. Here, we present a summary of the epidemiology, pathophysiology, diagnosis, and treatment of cerebrovascular disease in chronic kidney disease from the Kidney Disease: Improving Global Outcomes Controversies Conference on central and peripheral arterial disease with a focus on knowledge gaps, areas of controversy, and priorities for research.

Background: In 2020, the Guidelines Task Force conducted another systematic review of the relevant literature on deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) to update the original 2014 guidelines to ensure timeliness and accuracy for clinical practice., Objective: To conduct a systematic review of the literature and update the evidence-based guidelines on DBS for OCD., Methods: The Guidelines Task Force conducted another systematic review of the relevant literature, using the same search terms and strategies as used to search PubMed and Embase for relevant literature. The updated search included studies published between 1966 and December 2019. The same inclusion/exclusion criteria as the original guideline were also applied. Abstracts were reviewed and relevant full-text articles were retrieved and graded. Of 864 articles, 10 were retrieved for full-text review and analysis. Recommendations were updated according to new evidence yielded by this update., Results: Seven studies were included in the original guideline, reporting the use of bilateral DBS as more effective in improving OCD symptoms than sham treatment. An additional 10 studies were included in this update: 1 class II and 9 class III., Conclusion: Based on the data published in the literature, the following recommendations can be made: (1) It is recommended that clinicians utilize bilateral subthalamic nucleus DBS over best medical management for the treatment of patients with medically refractory OCD (level I). (2) Clinicians may use bilateral nucleus accumbens or bed nucleus of stria terminalis DBS for the treatment of patients with medically refractory OCD (level II). There is insufficient evidence to make a recommendation for the identification of the most effective target.The full guidelines can be accessed at https://www.cns.org/guidelines/browse-guidelines-detail/deep-brain-stimulation-obsessive-compulsive-disord., (© Congress of Neurological Surgeons 2021.)

Background: Managing cancer pain once it is refractory to conventional treatment continues to challenge caregivers committed to serving those who are suffering from a malignancy. Although neuromodulation has a role in the treatment of cancer pain for some patients, these therapies may not be suitable for all patients. Therefore, neuroablative procedures, which were once a mainstay in treating intractable cancer pain, are again on the rise. This guideline serves as a systematic review of the literature of the outcomes following neuroablative procedures., Objective: To establish clinical practice guidelines for the use of neuroablative procedures to treat patients with cancer pain., Methods: A systematic review of neuroablative procedures used to treat patients with cancer pain from 1980 to April 2019 was performed using the United States National Library of Medicine PubMed database, EMBASE, and Cochrane CENTRAL. After inclusion criteria were established, full text articles that met the inclusion criteria were reviewed by 2 members of the task force and the quality of the evidence was graded., Results: In total, 14 646 relevant abstracts were identified by the literature search, from which 189 met initial screening criteria. After full text review, 58 of the 189 articles were included and subdivided into 4 different clinical scenarios. These include unilateral somatic nociceptive/neuropathic body cancer pain, craniofacial cancer pain, midline subdiaphragmatic visceral cancer pain, and disseminated cancer pain. Class II and III evidence was available for these 4 clinical scenarios. Level III recommendations were developed for the use of neuroablative procedures to treat patients with cancer pain., Conclusion: Neuroablative procedures may be an option for treating patients with refractory cancer pain. Serious adverse events were reported in some studies, but were relatively uncommon. Improved imaging, refinements in technique and the availability of new lesioning modalities may minimize the risks of neuroablation even further.The full guidelines can be accessed at https://www.cns.org/guidelines/browse-guidelines-detail/guidelines-on-neuroablative-procedures-patients-wi., (Copyright © 2020 by the Congress of Neurological Surgeons.)

Objectives: The AJCC 8th edition (AJCC 8) has introduced depth of invasion (DOI) and extranodal extension (ENE) into staging for oral squamous cell carcinoma (OSCC). Although validations have been performed on institutional datasets have shown a good performance, particularly in early OSCC, there have been no studies on diverse patient populations that determine the impact on prognostic heterogeneity., Materials and Methods: Retrospective analysis of 4710 patients with oral squamous cell carcinoma (OSCC) treated with surgery +/- adjuvant therapy in 8 institutions in Australia, North America and Asia. With overall survival (OS) as endpoint, the prognostic performance of AJCC 7th and 8th editions were compared using Akaike Information Criterion (AIC), Bayesian Information Criteria (BIC), Harrell's concordance index (C-index)., Results: When comparing AJCC 8 to AJCC 7, the heterogeneity in prediction of OS increased for T-category and N-category while remaining unchanged for TNM staging, suggesting AJCC 8 increased complexity with no improvement in predictive value. There were significant differences in median DOI and incidence of ENE between geographical regions, resulting in dissimilar rates of stage-migration when adopting AJCC 8., Conclusion: In an attempt to improve prognostic performance, AJCC 8 introduced more variables; however heterogeneity in these results in significant geographical differences in model discrimination and performance. Caution should be applied as this may result in inaccurate and unreliable prognostic predictions that may impact treatment recommendations., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

The use of visual presentations to accompany talks has become the established standard in Medical Informatics conferences and has been the sine qua non at AMIA for many years. The most widely used software tool to prepare these presentations has been PowerPoint. AMIA has requested that researchers create their presentations using a standardized template and make them available ahead of time on the AMIA agenda website, typically as .pptx or .pdf files. In this paper, we are providing a few observations about uptake by the community, but, more importantly, we are making tentative steps towards answering questions about the quality of the visual presentation files. The paper starts with a review of four sets of guidelines for good PowerPoint presentations. It then provides basic descriptive statistics and structural observations about the 2019 AMIA presentations available on AMIA's website and concludes with a few recommendations for the future., (©2020 AMIA - All rights reserved.)

At the 8th conference of Occupational and Environmental Exposure of the Skin to Chemicals (OEESC) (16-18 September 2019) in Dublin, Ireland, several researchers performing skin permeation assays convened to discuss in vitro skin permeability experiments. We, along with other colleagues, all of us hands-on skin permeation researchers, present here the results from our discussions on the available OECD guidelines. The discussions were especially focused on three OECD skin absorption documents, including a recent revision of one: i) OECD Guidance Document 28 (GD28) for the conduct of skin absorption studies (OECD, 2004), ii) Test Guideline 428 (TGD428) for measuring skin absorption of chemical in vitro (OECD, 2004), and iii) OECD Guidance Notes 156 (GN156) on dermal absorption issued in 2011 (OECD, 2011). GN156 (OECD, 2019) is currently under review but not finalized. A mutual concern was that these guidance documents do not comprehensively address methodological issues or the performance of the test, which might be partially due to the years needed to finalize and update OECD documents with new skin research evidence. Here, we summarize the numerous factors that can influence skin permeation and its measurement, and where guidance on several of these are omitted and often not discussed in published articles. We propose several improvements of these guidelines, which would contribute in harmonizing future in vitro skin permeation experiments., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Abdominal and peritoneal pain after surgery is common and burdensome, yet the lack of standardized diagnostic criteria for this type of acute pain impedes basic, translational, and clinical investigations. The collaborative effort among the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, American Pain Society, and American Academy of Pain Medicine Pain Taxonomy (AAAPT) provides a systematic framework to classify acute painful conditions. Using this framework, a multidisciplinary working group reviewed the literature and developed core diagnostic criteria for acute abdominal and peritoneal pain after surgery. In this report, we apply the proposed AAAPT framework to 4 prototypical surgical procedures resulting in abdominal and peritoneal pain as examples: cesarean delivery, cholecystectomy, colorectal surgical procedures, and pancreas resection. These diagnostic criteria address the 3 most common surgical procedures performed in the United States, capture diverse surgical approaches, and may also be applied to other surgical procedures resulting in abdominal and peritoneal pain. Additional investigation regarding the validity and reliability of this framework will facilitate its adoption in research that advances our comprehension of mechanisms, deliver better treatments, and help prevent the transition of acute to chronic pain after surgery in the abdominal and peritoneal region. PERSPECTIVE: Using AAAPT, we present key diagnostic criteria for acute abdominal and peritoneal pain after surgery. We provide a systematic classification using 5 dimensions for abdominal and peritoneal pain that occurs after surgery, in addition to 4 specific surgical procedures: cesarean delivery, cholecystectomy, colorectal surgical procedures, and pancreas resection., (Copyright © 2020 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Skin sensitising substances that induce contact allergy and consequently risk elicitation of allergic contact dermatitis (ACD) remain an important focus regarding the replacement of animal experimentation. Current in vivo methods, notably the local lymph node assay (LLNA) refined and reduced animal usage and led to a marked improvement in hazard identification, characterisation and risk assessment. Since validation, regulatory confidence in the LLNA approach has evolved until it became the first choice assay in most regulated sectors. Currently, hazard identification using the LLNA is being actively replaced by a toolbox of non-animal approaches. However, there remains a need to increase confidence in the use of new approach methodologies (NAMs) as replacements for LLNA sensitiser potency estimation. The EPAA Partners Forum exchanged the current state of knowledge on use of NAMs in various industry sectors and regulatory environments. They then debated current challenges in this area and noted several ongoing needs. These included a requirement for reference standards for potency, better characterisation of applicability domains/technical limitations of NAMs, development of a framework for weight of evidence assessments, and an increased confidence in the characterisation of non-sensitisers. Finally, exploration of an industry/regulator cross-sector user-forum on skin sensitisation was recommended., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Chronic low back pain (CLBP) conditions are highly prevalent and constitute the leading cause of disability worldwide. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION) public-private partnership with the US Food and Drug Administration and the American Pain Society (APS), have combined to create the ACTTION-APS Pain Taxonomy (AAPT). The AAPT initiative convened a working group to develop diagnostic criteria for CLBP. The working group identified 3 distinct low back pain conditions which result in a vast public health burden across the lifespan. This article focuses on: 1) the axial predominant syndrome of chronic musculoskeletal low back pain, 2) the lateralized, distally-radiating syndrome of chronic lumbosacral radicular pain 3) and neurogenic claudication associated with lumbar spinal stenosis. This classification of CLBP is organized according to the AAPT multidimensional framework, specifically 1) core diagnostic criteria; 2) common features; 3) common medical and psychiatric comorbidities; 4) neurobiological, psychosocial, and functional consequences; and 5) putative neurobiological and psychosocial mechanisms, risk factors, and protective factors. PERSPECTIVE: An evidence-based classification of CLBP conditions was constructed for the AAPT initiative. This multidimensional diagnostic framework includes: 1) core diagnostic criteria; 2) common features; 3) medical and psychiatric comorbidities; 4) neurobiological, psychosocial, and functional consequences; and 5) putative neurobiological and psychosocial mechanisms, risk factors, and protective factors., (Copyright © 2020. Published by Elsevier Inc.)

Nursing faculty are predominantly women, and many are of childbearing age. Academic responsibilities for nursing faculty include attendance at scientific meetings and conferences. When nursing faculty members are breastfeeding, situations arise that may require them to make difficult decisions to meet both demands as mothers and academics. The purpose of this article is to describe the experiences of three nursing faculty members who brought their breastfed infants to professional nursing conferences, as well as identify major barriers to an inclusive working environment that cultivates "work-life balance" and propose workable solutions for breastfeeding mothers in academe., (© Copyright 2020 Creative Health Care Management.)

The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug's perceived benefit-risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit-risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics., (Copyright © 2020, the American Society of Anesthesiologists, Inc. All Rights Reserved.)

Science is expected to be borderless and inclusive of any interested individuals. The efforts made by academic institutions to promote diversity and inclusiveness are unfortunately undermined by discriminatory government policies. Iranian researchers suffer from limited mobility for attending scientific gatherings and are underrepresented due to lack of exposure, as they can be subject to discrimination for entering some countries, e.g. the US travel ban. As an Iranian citizen, I was denied an academic visitor visa to attend FEMS congress in Glasgow in 2019 to share my Ph.D. research results. This resulted in considerable waste of time, funds and efforts leaving me with a great deal of pain and frustration. In this article, I share my story to help raise awareness about compromised equity in the scientific community as a result of institutional discrimination and racism., (© FEMS 2020.)

The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. PERSPECTIVE: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry., (Copyright © 2020. Published by Elsevier Inc.)

Background: Effective teaching and learning strategies in online postconference can assist students to find meaning within clinical experiences., Purpose: To explore this, we completed a literature review about meaningful learning in online clinical postconferencing in prelicensure nursing education., Methods: Articles that were peer-reviewed, published within the last 10 years, written in English, and addressed online learning in clinical postconferences in prelicensure nursing programs were included., Results: Analysis revealed the following themes: connecting theory to practice, reflective practice, impact on future practice, peer and instructor support, mentoring and leadership development, giving and receiving feedback effectively, critical thinking, and engagement of active learners. Gaps were evident with minimal evidence-based practice described related to postconferences in general. Additionally, there is limited discussion of online postconferencing., Conclusions: Understanding the nuances of meaningful learning in online postconference is critical to facilitating students' ability to connect theory to practice.

Summary: The Canadian Network for International Surgery (CNIS) hosted a workshop in May of 2020 with a goal of critically evaluating Trauma Team Training courses. The workshop was held virtually because of the coronavirus disease 2019 (COVID-19) pandemic. Twenty-three participants attended from 8 countries: Canada, Guyana, Kenya, Nigeria, Switzerland, Tanzania, Uganda and the United States. More participants were able to attend the virtual meeting than the traditional in-person meetings. Web-based videoconference software was used, participants presented prerecorded PowerPoint videos, and questions were raised using a written chat. The review proved successful, with discussions and recommendations for improvements surrounding course quality, lecture content, skills sessions, curriculum variations and clinical practical scenarios. The CNIS's successful experience conducting an online curriculum review involving international participants may prove useful to others proceeding with collaborative projects during the COVID-19 pandemic.

Background: Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2; COVID-19), which causes coronavirus disease 2019, is highly contagious and a particularly popular problem in all around the world and also in all departments of every hospital., Aims: Protecting the well-being of the aesthetic dermatologists while providing a sufficient workforce is vital for pandemic planning., Results and Conclusions: In this article, we will discuss this problem from an aesthetic dermatology aspect and we will review whether these procedures are safe or not., (© 2020 Wiley Periodicals LLC.)

Study Design: Systematic review., Objective: We systematically reviewed the level of clinical evidence presented at Cervical Spine Research Society annual meetings from 2008 through 2017., Summary of Background Data: The Cervical Spine Research Society is dedicated to advancing knowledge of the cervical spine to promote evidence-based care. Research presented at these meetings impacts clinical practice., Methods: A total of 774 paper abstracts presented at Cervical Spine Research Society (CSRS) annual meetings were independently assessed by two reviewers. Reviewers designated a clinical level of evidence (LOE) to each included abstract from level I to level IV based on criteria set forth by the Oxford Centre for Evidence-Based Medicine. Reviewer agreement was assessed using Cohens Kappa coefficient (k) and disagreements were discussed until a consensus was reached. Wilcoxon rank sum test was used to assess for differences in LOE grades. Chi-squared testing was used to assess nonrandom changes in level of evidence and in excluded studies., Results: A total of 583 abstracts were included. Over the last 10 CSRS meetings, 5.15% of presentations were level I, 27.8% level II, 27.4% level III, and 39.6% level IV. The average LOE from 2008 to 2017 was 3.02 (median = 3). Additionally, 49.7% were therapeutic studies, 37.6% prognostic studies, and 12.7% diagnostic studies. When comparing the first 5 years (2008-2012) to the last 5 years (2013-2017), we observed a significant increase in Level II (P = 0.007) evidence and a corresponding decrease in level IV evidence (P < 0.001). The average LOE improved from 3.14 (2008-2012) to 2.91 (2013-2017); there was a significant improvement in LOE between the two periods (P = 0.001)., Conclusion: Emphasis on evidence-based medicine within cervical spine research has positively influenced the clinical level of evidence disseminated at CSRS annual meetings between 2008 and 2017. Continued focus on higher quality Level I studies is warranted., Level of Evidence: 4.

Background: Medical meetings are a tool to help physicians advance and update their medical knowledge. Their quality is the responsibility of colleges and institutions., Objective: To assess and compare the academic level of four different annual rheumatology meetings., Material and Methods: As a source of information, we used the abstracts published in the supplements of the journal Reumatología Clínica, SE1 Vol. 12, issued in February 2016, SE 1 Vol. 13 issued in February 2017, the electronic application of the 2016 ACR/ARHP of the 2016 American Congress of Rheumatology, devoted to the works presented at the 44th Mexican Congress of Rheumatology (CMR 44), the 45th Mexican Congress of Rheumatology (CMR 45), and the 2016 ACR/ARHP Annual Meeting (ACR 2016), as well as the Web page on the files and abstracts of EULAR 2017, respectively; from each work we compiled information on the major disease being referred to, the type of information provided and the type of report. We should point out that some were combined conditions or designs, from which we selected that which we considered to be the most important., Results: In all, 275, 340, 3275 and 4129 studies were submitted to the XLIV Mexican Congress of Rheumatology, XLV Mexican Congress of Rheumatology, the 2016 ACR/ARHP Annual Meeting and EULAR 2017, respectively. Rheumatoid arthritis was the most common disorder, dealt with in 23%, 26%, 21% and 27% in CMR 44, CMR 45, 2016 ACR and EULAR 2017, respectively, followed by systemic lupus erythematosus; in third place, Mexican congresses reported trials related to systemic vasculitis, whereas spondylitis was the main subject of international congresses. In the case of rheumatoid arthritis, clinical topics accounted for 30% in the Mexican congresses and ACR, and nearly 20% in EULAR. Observational studies accounted for 40% in the Mexican congresses vs. 33% in 2016 ACR and 55% in EULAR 2017. Studies on basic science were minimal in the Mexican congress, whereas in 2016 ACR, they represented 21% and 12% in EULAR 2017., Conclusion: Rheumatology meetings constitute a tool to obtain adequate evidence-based medical knowledge in this important branch of medicine. For our Mexican Congress, we should encourage collaborative efforts between institutions, which will result in a greater number of controlled studies, clinical trials and basic studies that support the quality of the congress. We wish to emphasize that a greater diffusion of other musculoskeletal diseases is needed, not only autoimmune diseases, since the former represent an important percentage of the daily practice., (Copyright © 2018 Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. Publicado por Elsevier España, S.L.U. All rights reserved.)

Dental professionals are encouraged by the American Dental Association (ADA) to recommend the HPV vaccine to eligible patients. To better understand their comfort level in following this recommendation, we conducted a mixed methods study of dentists and dental hygienists. A total of 173 providers were surveyed and 8 interviewed. The majority felt they had an important role in preventing HPV-related OPC and that they should educate their patients and encourage HPV vaccination. However, most providers had low knowledge about HPV and expressed a need to obtain more information on the topic. In particular, they desired information about the HPV vaccine, its connection to cancer and where to refer patients for vaccination. They also wanted access to visual aids to help them bring up the topic. This study demonstrates the need to develop and disseminate educational programs for dental providers so they can assist with efforts to raise HPV vaccination rates., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

An international collaborative study was organised to establish the 3rd World Health Organization (WHO) International Standard (IS) for amphotericin B. Sixteen laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 2nd IS for amphotericin B was used as a reference. Based on the results of the study, the 3rd IS for amphotericin B was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2019 with an assigned potency of 953 International Units (IU) per mg. The 3rd IS for amphotericin B is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM)., (© Council of Europe 2020.)

An international collaborative study was organised to establish the 3rd World Health Organization (WHO) International Standard (IS) for Erythromycin. Fifteen laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 2nd IS for Erythromycin was used as a reference. Based on the results of the study, the 3rd IS for Erythromycin was adopted at the meeting of the WHO Expert Committee on Biological Standardization (ECBS) in 2018 with an assigned potency of 925 International Units (IU) per mg. The 3rd IS for Erythromycin is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM)., (© Council of Europe 2020.)

Two preparations of the chimeric anti-Tumour Necrosis Factor (TNF) monoclonal antibody Infliximab were formulated and lyophilised at the National Institute for Biological Standards & Control (NIBSC) prior to evaluation in a collaborative study for their suitability to serve as a World Health Organization (WHO) International Standard (IS)/European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for the potency assay of Infliximab. Twenty-six laboratories tested the preparations using different in vitro cell-based bioassays (TNF-α neutralisation, antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity) and binding assays. Amongst them, 19 laboratories performed cell-based bioassays. The results of this study indicated that the candidate preparation coded 16/170 was suitable to serve as an International Standard for Infliximab based on the data obtained for biological activity. This candidate standard was established in 2017 as the first International Standard for Infliximab with an assigned potency for TNF neutralisation activity of 500 IU per ampoule. In the same study, the suitability of preparation 16/170 of Infliximab to serve as the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for the Infliximab potency assay as described in the Ph. Eur. monograph on Infliximab concentrated solution (2928) was also evaluated. The corresponding analysis, based on the measurement of the inhibitory action of anti-human TNF (Infliximab) on the cytotoxic activity of TNF-alpha, was performed using data from a subset of 9 laboratories using the TNF-alpha-sensitive fibrosarcoma cell line WEHI-164. The results obtained were compared to those obtained from different cell-based neutralisation assays that were used by other laboratories in the context of establishing the 1st World Health Organization (WHO) International Standard (IS) for Infliximab. Based on the analyses, preparation 16/170 was adopted by the Ph. Eur. Commission in June 2018 as Infliximab BRP batch 1 with an assigned potency of 500 IU per ampoule., (© Council of Europe 2020.)