BSTP Call for Papers – Ocular Pathology and Drug Development
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BSTP – Call for Papers for the next special issue of Toxicologic Pathology Journal
Toxicologic Pathology is pleased to announce the publication of a special 2020 issue focusing on The Challenges of Inhaled Biotherapeutics. This peer-reviewed issue will bring together experts in the field of inhalation toxicology and pathology to provide an overview of the commonly encountered challenges associated with inhaled biologics. This issue will be forwarded by two white papers–the first addressing the pathological effects commonly seen with inhaled biologics and their implications for drug development, and the second addressing the toxicological and technical challenges associated with this route of delivery.
CLICK HERE for more information.
This call for papers seeks manuscripts from authors with experience in inhalation toxicology or the nonclinical development of inhaled biologics.
Toxicologic Pathology is pleased to announce the publication of a special 2020 issue focusing on Stem Cell-based Therapy Development. Rapid advances in stem cell biology have produced confusion and misinformation on the readiness of this field for clinical use in humans and animals. This peer reviewed special issue will emphasize the issues concerning cell therapies, exemplified but not limited to stem cell and related fields. Major focus will be safety assessment, issues complicating nonclinical development of stem cell therapies, including study design, methods for evaluating histopathology findings, carcinogenicity evaluation, immune compatibility, and solutions to these issues to propel the field into the future therapies. This issue will explore concepts such as the fate of injected stem cells, teratoma formation and neoplasia, ectopic growths, use of autologous induced stem cells, use of stem cells in veterinary medicine and present state of the field. Also included will be issues of terminology and standardization of methods and nomenclature.
CLICK HERE for more information.
The Biomedical Research Education Trust
Call for proposals
The Biomedical Research Trust (BRET) is a charity which funds work to improve the care, use and replacement of animals in scientific research and increased public understanding of the role of animals in biomedical research. Previous projects include schools speaker programmes, education for veterinary students, preparation of on line resources and travel bursaries.
We are inviting proposals for funding further work in two categories :
- Improved public education and understanding of the role of research using animals in the biological sciences, including medical advances
- to promote the use and development of 3Rs methods
Proposals should be brief, explaining how the work meets the aims of BRET, what you plan to do and a breakdown of costs. Grants are usually up to £5000 but proposals for bigger projects may be considered.
If you would like to discuss an idea before submitting please contact us at bretenquiries@btinternet.com
BRET: Registered charity no 292366
The Pathologist – Webinar
Stay up to date with next-generation multiplex fluorescence immunohistochemistry methods
You are invited to attend a webinar hosted by Alexander Klimowicz, Senior Principal Scientist at Boehringer Ingelheim Pharmaceuticals. This webinar will focus on user experiences with the Ultivue InSituPlex® fluorescence multiplex IHC platform and provide insight into how this technology can be applied in a research setting to address current challenges, enhance research workflow, and create new opportunities for IHC-based experimentation.
Next-generation multiplex fluorescence immunohistochemistry methods offer new capabilities for scientists to explore the biology of disease within patient tissues. New detection methods based on DNA barcoding of primary antibodies, combined with barcode-specific fluorophores, enable higher-plex assays using standard fluorescence microscopy infrastructure. These methods also have the potential to enable more accurate co-expression analysis, higher-resolution target detection, and streamlined multiplex assay development
Date: June 13, 2019
Time: 9am EDT
Click here for more information and to register your place.
BSTP Membership Renewal for 2019
You are reminded that to avoid the late payment fee, please ensure that your payment is received by the BSTP on or before 23.59 on Tuesday 30th April. Any payments received after 00.01 on 1st May, will automatically include the £25 late payment fee. For those members subscribing to the journal, your subscription may be suspended after 1st May until your payment is received.
Several notices have been sent out since January advising that your membership payment would be due for payment on 1st April 2019, and as a reminder the fees are as follows:
£60 - BSTP Member - without Journal
£160 - BSTP Member - with Journal (print and online access, including INHAND Supplements = £60 + £100)
£115 - BSTP Member - with Journal (online access only = £60 + £55)
Please renew online and pay by credit card – the preferred option - to start the renewal process, visit http://www.bstp.org.uk/membership-page/
If you would rather pay by bank transfer, please ensure that payment is made in GBP and that you pay the full amount due within 14 days of the generation of your renewal paperwork. If you pay by bank transfer from outside the UK, you need to ensure that the BSTP receive the full amount due or add £10 to cover any bank or exchange rate charges. If you have an automatic bank transfer payment set up to pay the BSTP, you need to remember that you still need to complete the online renewal process so that we have on file the paperwork, both for financial and data protection reasons.
The BSTP are no longer able to accept payments by cheque.
Once the payment has been processed, you will automatically receive confirmation of your renewal, don't forget, to download your own receipt or invoice. The BSTP Secretariat will be notified of your renewal and unless there are any problems, there will be no need for the Secretariat to contact you to confirm your renewal.
If you have any problems renewing your membership online or your circumstances have changed and you prefer not to renew your membership at this time, please contact the BSTP Secretariat as soon as possible.
2019 ACVP Mid-Career Awards
Nominations for the 2019 ACVP Mid-career Awards in Research, Diagnostics, and Education are open. Please note that nominations and receipt of these awards are limited to ACVP members in good standing.
ACVP_2019_-_Mid-Career_Excellence_Award.pdf (680.6 KiB, 118 hits)
Applications may be accessed in the members only section of the ACVP website - https://www.acvp.org/
EMA communications
The EMA London offices has moved to Amsterdam, The Netherlands.
See full details on our website:
https://www.ema.europa.eu/en/about-us/contact/how-find-us#official-address-from-4-march-2019-section
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
The European Medicines Agency (EMA) has released for public consultation an open call for data on use of antimicrobials in animals.
Regulation (EU) 2019/6 on veterinary medicinal products, which sets the future regulatory framework for veterinary medicines, provides a wide range of concrete measures to fight antimicrobial resistance and to promote the prudent use of antimicrobials. Such measures include, in particular, the possibility to reserve certain antimicrobials for treatment of certain human infections only, in order to preserve their efficacy.
The European Commission has asked the EMA to provide scientific advice on how these provisions could best be addressed in forthcoming additional legislation.
In order to support the EMA in the preparation of its scientific advice, the CVMP invites all interested parties, such as pharmaceutical industry, veterinarians, professional groups, learned societies, governmental institutions as well as EU and EEA Member States to submit information on cascade use of antimicrobials in animals and any scientific evidence of an impact on public and animal health that the CVMP should consider.
We kindly ask you to respond to the questions by filling in the questionnaire: https://ec.europa.eu/eusurvey/runner/OpenCallUseofantimicrobialsinanimals (please note, that these questions relate to EU practices only).
Please provide details of your area of work (e.g. veterinarian and type of practice, industry, professional body) and country where you are located at the top of the template. Please note that your responses will be considered anonymously. The data collected will be used to inform the advice provided to the Commission on the Implementing Acts under the new Regulation 2019/6. It may be included in the report in an aggregated format.
The call is open until 6 March 2020. For more details, please consult the open call, which includes the list of questions.
The European Medicines Agency has released for public consultation the concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products.
With the aim of promoting availability of veterinary medicines, the Agency established in 2009 (revised in 2014) a policy, complemented by supporting guidance, for Minor Uses/Minor Species which defined a procedure for classification of products as MUMS as well as the support provided to companies submitting marketing authorisation applications for veterinary medicinal products that have been classified as MUMS/Limited markets. This support includes financial incentives (fee waivers and fee reductions) and reduced data requirements.
The CVMP developed specific guidelines detailing reduced data requirements for products classified as MUMS in relation to quality, efficacy and safety of pharmaceutical veterinary medicinal products also in relation to immunological veterinary medicinal products. The guidelines were initially developed in 2006 and 2007 and subsequently revised in 2016.
The current guidelines were developed with the aim of reducing data requirements, where possible, for products classified as MUMS/Limited markets, according to the Agency’s policy, while still providing assurance of appropriate quality, safety, and efficacy, and complying with the legislation in place, leading to an overall positive benefit-risk balance for the product.
The draft guideline is available by clicking here.
Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu by 31 January 2020.
The European Medicines Agency has published the “Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use”.
This guideline has been revised and provides new text to be included in the package leaflet of medicines containing ethanol as excipient. It contains more detailed information on the effects of ethanol when used as excipient, in particular on babies and children.
This document is the Annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use. It contains the information which should appear in the package leaflet for the excipients known to have a recognised action or effect. The annex is effective from 22 November 2019.
For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.
For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex
Please find a link to additional information on the Annex. The rational for revising information on ethanol, which went through public consultation, has also been published: Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use.
We would like to inform you that the call for express of interest to participate in the European Medicines Agency (EMA) third Awareness Session, focused on science and regulation for animal health and welfare is now open.
The session will be held at the EMA in Amsterdam, on Thursday 2 and Friday 3 April 2020.
This awareness session will give an insight into the Veterinary EU regulatory system and the role of EMA and the EU network, and into specific aspects of the new veterinary medicines regulation. It will address Veterinary topics such as antimicrobial resistance, support for innovation and collaboration with Academia. In addition, there will be parallel sessions on more specific topics, such as animal welfare, food safety and security, Veterinary medicines and the environment and Animals & society.
The early programme overview is attached for more details.
Places are limited so early expression of interest is recommended and should be sent to EMA at EMAinternational@ema.europa.eu by 2 March 2020. The session will also be broadcast and selected information published on the EMA website after the event.
Please note that there is no registration fee but the EMA will not fund participation, nor reimburse travel, visas, or accommodation.
The European Medicines Agency has released today for public consultation two draft consultation papers:
This document provides internationally harmonised recommendations for criteria on data requirements to waive laboratory animal batch safety testing of veterinary vaccines in regions where it is required.
Deadline for comments: 10 April 2020
The CVMP has adopted a draft reflection paper on ‘Promoting the authorisation of alternatives to antimicrobials in the EU’. This draft reflection paper has been developed to identify additional measures that could be implemented to promote the authorisation of alternatives to antimicrobials in the EU
Deadline for comments: 30 April 2020
Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu.
The European Medicines Agency has published for public consultation three European Union herbal monographs on:
Deadline for comments: 15 January 2020.
Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.
The European Medicines Agency has released for public consultation a draft CVMP Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU.
Antimicrobial resistance (AMR) is now recognised as a major threat to human and animal health. The European Medicines Network Strategy to 2020 highlights that, with respect to veterinary medicines, controlling the risks of AMR arising from the use of antimicrobials, and particularly arising from the non-prudent use, is one of the highest priorities related to animal and public health.
This reflection paper performs a gap analysis by reviewing the measures currently in place to support the authorisation of alternatives to antimicrobials (ATAm) in veterinary medicine, with particular emphasis given to alternatives to antibiotics, and identifying where and how these could be improved.
The draft paper is available by clicking here.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 30 April 2020.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
The EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022.
On this webpage, stakeholders can find all relevant information regarding EMA’s scientific and technical recommendations to the European Commission that will feed into delegated and implementing acts as part of the implementation of the legislation, as well as updates on other activities such as the preparation for implementation progresses.
The new regulation contains new measures for increasing the availability of veterinary medicines and enhances EU action against antimicrobial resistance, a high priority for the Agency and the European medicines regulatory network. It also aims to reduce administrative burden and encourage medicine innovation and development.
For more details, please click here.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
EMA has published a questions-and-answers (Q&A) document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU.
It explains that in case of a withdrawal agreement, there will be a transition period during which EU law will continue to apply in the United Kingdom. This means that access to medicines will not be affected.
If the UK leaves without a withdrawal agreement or deal (‘no-deal scenario’), EU law will cease to apply in the UK. In this case, in order to be able to continue to supply medicines in the EU, companies carrying out certain activities in the UK will need to make changes to comply with EU law.
The Q&As explain how EMA, the European Commission and EU/EEA Member States have been working closely together since May 2017 to advise companies on how to apply for the necessary changes in order to minimise the impact on the supply of medicines, if the UK leaves the EU without a withdrawal agreement.
The document underlines that Brexit will not impact the safety of medicines, nor the way they are evaluated. EMA and the Member States will continue to monitor the safety and efficacy of medicines without any changes.
This document applies to both human and veterinary medicines and will be updated as necessary.
Industry preparations for new Brexit deadlines
In view of the conclusion of the European Council on 22 March to extend the date of the withdrawal of the UK from the EU, EMA calls on all pharmaceutical companies in the EU to continue their preparedness activities, taking into account all possible outcomes. Based on the European Council conclusions, the deadline of 29 March referred to in EMA’s published Brexit-related guidance should be understood to be replaced by 12 April 2019 until further notice.
Further information is available by clicking here.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
We are pleased to send you our latest edition of the monthly Newsletter which includes decisions by our Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.
You can access the Newsletter by clicking here. Previous editions can also be found on this page.
BSTP/STP Webinar: Experimental Pathology Slide Review
BSTP/STP Webinar: Experimental Pathology Slide Review
The third Experimental Pathology Slide Review BSTP/STP case webinar was held on Tuesday 18th September 2018.
To access a recording of the webinar, please logon to the MEMBERS ONLY area of the BSTP website and view the WEBINARS page.
If you have forgotten your login details please contact the BSTP Secretariat - bstpoffice@aol.com
BSTP – EPSR Metadata
The EPSR Co-ordinator would like to thank everyone who has registered by returning their EPSR Website Access T&Cs. If this is still on your to do list, the form is available in the EPSR section in the members only area of the website.
Also available is a filterable Excel spreadsheet containing the species, tissue and finding of each EPSR case for ease of identifying lesions of interest and we are now able to share the original case descriptions and discussions if any more detail is required on any of the cases in the EPSR archive.
I hope you agree that this is an exciting offering from the BSTP that will benefit all our members as well as enhancing future Webinars, Continuing Education Symposia and Annual Scientific Meetings, where we can also make use of this facility to share scanned slides. New cases for future use are always very welcome so if you have any interesting or unusual lesions or cases please contact the EPSR Co-ordinator via the BSTP Secretariat.
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