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Below is the July issue of the Davis-Thompson Foundation Newsletter, brilliantly prepared, as always, by Stephanie Shrader and Javier Asin, our wonderful editors.

The Newsletter is loaded with free or low cost training opportunities provided by the Foundation and our traditional CE and MOC credits .

In addition, this month we are also very happy to announce the winner of the first contest for pathology images: Dr Nataly Mamaliger. See her beautiful lymphangiectasia image on the front page of the newsletter. Congratulations Dr Mamaliger! This contest was organized by Dr Kate Watson, to whom we thank from the bottom of our hearts!

Looking forward to seeing you at one or more of our upcoming seminars.

Enjoy

Paco Uzal, Davis/Thompson Foundation CEO

Enjoy the full-resolution version of the July 2021 newsletter -

  DTF_Newsletter_-_July_2021.pdf (9.8 MiB, 10 hits)

Keeping track of webinars and for prompt information and networking, join our social media:

If you use Google calendar, please feel free to sync your calendar with the Davis-Thompson Webinar Calendar linked below. Make sure to save in your timezone, to set reminders to ON and never miss a webinar again!

https://calendar.google.com/calendar/u/1?cid=Y19mdWQ2c3Y4aG5qa3ExODRtdXByMGdnZ3Nyc0Bncm91cC5jYWxlbmRhci5nb29nbGUuY29t

Facebook: https://www.facebook.com/groups/CLDavisFoundation/

YouTube: https://www.youtube.com/channel/UCvGM1s5wysXq-HGLAyZzClQ

You can also visit the Non-BSTP Events and Webinar Page - http://www.bstp.org.uk/non-bstp-events/

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It gives me enormous pleasure to announce that Dr Bruce Williams, Treasurer of the Davis Thompson Foundation, has been named a Distinguished Member of the American College of Veterinary Pathologists.

Bruce works tirelessly and with great pasion for Veterinary Pathology education and it is great to see these efforts acknowledged. We are all extremely proud of his achievements.

Read the full story in the June issue of the Foundation’s Newsletter.

Thanks!

Paco Uzal - Davis Thompson Foundation CEO

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We are ready for May! One the Non-BSTP events pages you will find the Davis-Thompson Foundation webinar schedule for May 2021 as well as upcoming courses. Please click on the webinar title to be directed to the registration page and find additional details on the flyers.

First, we have lots of news to cover!

• We are giving away registrations to a full-day webinars for those endorsing our mission by using our new Facebook frame. If you are not using it yet, what are you waiting for? If you are using it, look for a private message on Facebook on Fridays prior to a Full-Day webinar to see you have been selected for a free registration.

Frame in white
Frame in black 

• We are giving 10 scholarships for the rebroadcast Version of the 2021 Descriptive Veterinary Pathology Course (details attached). To apply follow the instructions in the document below:

 Descriptive Veterinary Pathology Course scholarship application

To ensure the information we bring you stays relevant and current, beginning July 31st, we will be removing from YouTube the Free-Friday and Full-Day webinars that are older than 6 months. Catch up on your favourites and while you are doing it, like and comment on the videos! We’ll be selecting likes/comments to give away registration to a Full-Day webinar!

YouTube channel

• In order to accommodate all time zones, from May forward, Full-Day webinar presentations that receive authorization for rebroadcast will be available for 14 days beginning 24 hours following the live broadcast, but for registrants only.

• To promote a continuous improvement culture we generate a survey for each webinar we put out via SurveyMonkey. Your opinion is then carefully analysed, shared with presenters and with our team. Please, keep those great insights coming by filling out our SurveyMonkey questionnaire. To show our appreciation for your feedback, we’ll be drawing a free registration to a Full-Day webinar to those who fill the Survey. Thank you for being an important part of our continuous improvement culture!

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As the Foundation has entered the digital age, we have entered with the bold new logo as well!

The Foundation’s symbol was created by Samuel Wesley Thompson (in the mid 1970s). The original design was actually a cloth patch - maroon in colour, this embroidered patch came with the V device, the snake, the shield, and the bay leaves. The maroon colour, the snake and the V were inspired by the emblem of the U.S. Army Veterinary Corps, where Dr. Charlie Louis Davis and Dr. Samuel Wesley Thompson met and spent their careers at. The bay leaves are traditional emblems of healing and the shield represents protection of animal and human health.

In the 1990s, a heraldic artist was commissioned to adapt the path to make a crest for the Foundation. The crest went through a few stages of evolution, over the years. First, it received a ribbon on top with the name of the Foundation at that time, the “C.L. Davis DVM Foundation” and a ribbon at the bottom with the Foundation's mission “Advancement of Veterinary Pathology”. In 2015 after the passing of Dr. Thompson and the subsequent change to the Foundation’s name, the top ribbon was changed to “Davis-Thompson DVM Foundation”.

But as we advance into the digital age, it is about time for a revamping of our beloved emblem. We hope you like it, and recognize it to be the symbol of excellence wherever you find it.

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Invitation to become a Foundation member!

Are you enjoying Foundation activities this year?  Have you attended one or more of our free seminars (in three languages) from around the globe?  Perhaps you participated in one of our review courses or its rebroadcast?  Or maybe you watched some of the literally hundreds of hours of video on our YouTube channel? Or maybe you just used one of the Foundation's Tumor Fascicles which you got for the crazy low price of $40 (or even less during one of our many book specials)?

It’s no secret that the Foundation volunteers are working extra hard to make all of this available to you, especially during these difficult times.  Our model is unique in our field – we make all of this great stuff available to you first, whether you are a member or not.  We could just hide it behind a paywall like everyone else so you have to become a member to get it, but that’s not how the Foundation operates.  We give you everything upfront, and hope you will support us with your membership.

If you want to support our continuing efforts, or just want to say "thank you" – consider becoming an individual, university, or corporate member.  (Did you know that universities and corporations can pay centrally, allowing all of their pathologists to become members without dipping into their own wallets?)  But individual members are very important to us, too!

Please take just a moment to read the letter below from Paco Uzal, Chief Executive Officer of the Foundation, which will not only give you the latest on what the Foundation is up to in its global mission, but also what the benefits of Foundation membership will mean for you.

  2021_Individual_Membership_Appeal.pdf (738.6 KiB, 25 hits)

And once again, thank you for supporting the Davis-Thompson Foundation.

Evelyn Cotton
Foundation Administrator

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Exciting news from the Davis-Thompson Foundation

Mind if a take a moment to share some exciting news that we are all very proud of here in the Foundation?

A decade ago, the Latin Comparative Pathology Group, in partnership with the Foundation, began publishing its Diagnostic Exercises.  First monthly, now twice monthly, young pathologists around the globe have published their cases online (http://www.cldavis.org/diag_exercise.html ).

Over the years, our DE committee and its senior editors, Vini Carreira and Claudio Barros have put in hours and hours of effort to maximize the educational potential of these outstanding case reports.

This month, we begin a partnership with the Brazilian Journal of Veterinary Pathology, and I will let them explain (by way of an editorial in this month's issue - https://bjvp.org.br/bjvp-archive/2021/03/vol-14-n-1-march-2021/.

"Diagnostic exercises of the Latin Comparative Pathology Group (Latin American Division of the Davis-Thompson Foundation) being published in the Brazilian Journal of Comparative Pathology

It is a great honor for the Latin Comparative Pathology Group (LCPG; the Latin American subdivision of the Davis-Thompson Foundation), to begin publishing our already famous diagnostic exercises in the Brazilian Journal of Veterinary Pathology (BJVP).

The diagnostic exercises of the LCPG were created more than 10 years ago, with the objective of sharing interesting pathology cases with the scientific community and to provide educational material for trainees. These cases generated great enthusiasm amongst students and veterinarians around the world, and over the years, more than 160 exercises have been distributed regularly by e-mail and published on line in the Davis Thompson Foundation and the American Association of Veterinary Laboratory Diagnosticians web pages.

Now, in a joint effort between the LCPG and the BJVP, three selected diagnostic exercises submitted to the LCPG will be published in each issue of the journal. We hope that this way, our diagnostic exercises will reach a broader readership throughout the globe.

We hope that you enjoy our diagnostic exercises whether you read them on the web or in the BJVP.

These exercises may be contributed by members and non-members of the LCPG from any country of residence. Please consider putting your interesting case in the form of a diagnostic exercise and submit it to the LCPG. It does not have to be something unusual and all sub-specialties of pathology are welcome! Contact the Editor in Chief, Dr Claudio Barros (e-mail…..), for instructions on how to prepare and share your diagnostic exercise.

Paola A. Barato, President Latin Comparative Pathology Group.

Francisco R. Carvallo, President-elect Latin Comparative Pathology Group.

Claudio S. Barros, Editor-in-chief, Latin Comparative Pathology Group diagnostic exercises.

Francisco A Uzal, Chief Executive Officer, Davis-Thompson Foundation"

So look for the Diagnostic Exercises in every edition of the Brazilian Journal of Veterinary Pathology - and please consider submitting your own case reports as Diagnostic Exercises!

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On the BSTP's non-BSTP and webinar pages you will find details of May's webinars and upcoming courses. Click on the webinar title to be directed to the registration page and find additional details on flyers.

Since last year we have been testing a close caption system on our webinars. Due to the positive feedback we have received, I am happy to inform you that it will be a permanent feature. You always have the option to turn it on or off as you please. To do this look for the "cc" box on the bottom of your zoom webinar window (see attached image).

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Davis-Thompson Foundation News and housekeeping:

• On our registration webpage, you will note that we are now asking for your license state/providence and license number if applicable. This information will be submitted to RACE as requested after the meeting, in order to validate our programs and your continuing education. RACE also recommends that you register for a free account at https://cebroker.com/ so your state board can track your attendance.
• This month we will start our membership drive. Stay tuned for an upcoming email with additional information. Meanwhile, if you agree that we bring you valuable information, please consider renewing or starting a membership. Members receive many benefits, some of which you can find listed via link: https://davisthompsonfoundation.regfox.com/individual-membership
• There is always the option to make a donation to the foundation here: https://davisthompsonfoundation.regfox.com/donation
• Joining a webinar. Please remember that you need to register for a webinar with the same email that you are registered on Zoom. You will not need a passcode to get in a webinar. For a step by step instructions please see the info chart in the attachments. If you don't know how to log into your zoom account, follow this video tutorial: https://youtu.be/N54rrH4HU5o

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For a limited time, for the promotional price of $175 USD (plus shipping), you could get:

- Surgical Pathology of Tumors Vol 1, 2 and 3

- The Necropsy Book, John King

- Metazoans and Protozoans in Tissue Section, Chris Gardiner

To order, please complete the attached order form.

  Christmas_Present_Special_1.docx (234.5 KiB, 128 hits)

Below are all the options for purchasing:

- ONLINE: http://store.cldavis.org/christmaspresentspecial.aspx

- EMAIL: cldavisdvm@comcast.net

- MAIL: send check/money order and form to:  The Davis Thompson Foundation, 6241 Formoor Lane, Gurnee, IL, 60031-4757, USA

- PHONE: (1) 847-367-4359

*8AM-12PM M-F except holidays

-  FAX: 847-247-1869 (24/7)

Please note:

- All postages under $100 will be automatically deducted and shipped. Shipping charges exceeding $100 will only be processed after your approval (via email).

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With the Davis-Thompson Foundation webinars we strive to bring you relevant and timely topics every week.

We want your experience to be as personal as possible. Therefore, we’ve created a place where you can communicate your suggestions for future topics directly to our team. Suggestions will be periodically analyzed by our expert (Dr. Laura Bassel) and top requests will be pursued for future webinars.

Make as many suggestions as you want, please keep it as succinct and possible (e.g. reproductive, congenital, etc) via this link: https://www.surveymonkey.com/r/DTFFuturetopics

You will be able to visualize all suggestions in real time through the link below https://www.surveymonkey.com/stories/SM-B7D6V93Y/

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Diagnostic Exercises (DEs) Guidelines for citing and referencing the literature

To make our DEs more uniform, I’m proposing some gradual changes in format. Let us start with some guidelines that will standardize the methods of citing and referencing the literature.

References
Citations of the literature in the text should be given with“author and year” always within parenthesis (e.g., Hadlow 1959). Papers w ith two authors should be cited with the name of both authors (e.g.. Mabbott and MacPherson 2006); citations with more than two authors must include the name of the first author followed by “et al.” and the year (e.g., Gajdusek et al. 1966). If two articles cited in the text cannot be distinguished from each other, please identify them by placing small letters alongside the year (e.g., Farquhar 1989a, 1989b). Cite the articles in the text by chronological order (e.g., Hadlow 1959, Gajdusek et al. 1966, Prusiner et al. 2004).

When listing the article in the reference list, please include all authors (see the example below). Include here only references cited in the body of the manuscript.
Farquar J., Sommerville R.A., Ritchie L.A. 1989a. Postmortem immunodiagnosis of scrapie and bovine spongiform encephalopathy. J. Virol Methods 24:215-222.
Farquhar J. & Gajdusek D.C., Ritchie L.A. 1989b. Kuru. Early Letters and Field notes from the Collection of D. Carleton Gajdusek. Raven Press, New York. p. 77-103.
Gajdusek D.C., Gibbs Jr, C.J., Alpers M.P. 1966. Experimental transmission of a kuru-like syndrome to chimpanzees. Nature 209:794-796.
Hadlow W.J. 1959. Scrapie and Kuru. Lancet 274:289-290.
Mabbott N.A. and MacPherson G.G. 2006. Prions and their lethal journey to the brain. Nature Rev Microbiol 4:201-2011.

When referencing books with Editor (Prusiner et al. 2004) or with one author and no Editor (e.g., Cummings 2010), please follow the examples below.

Prusiner S.B., Williams E., Laplanche J.-L., Shinagava M. 2004. Scrapie, chronic wasting disease, and transmissible mink encephalopathy, p. 545-5 94. In: Prusiner S.B. (Ed) Prion. Biology and Disease. 2nd ed. Cold Spring Harbor. New York.

Cummings L. 2010. Rethinking the BSE Crisis: A Study of Scientific Reasoning under Uncertainty. Springer, London. p. 101-193.

Try to use key-references, so the reference list does not end up too long. Please restrict the number of references to a maximum of 10.

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Diagnostic Exercises of the Latin Comparative Pathology Group/Davis-Thompson Foundation now accepted by ACVP as credits for Maintenance of Certification

Great news: The Latin Comparative Pathology Group (LCPG)/Davis-Thompson Foundation (DTF)’s Diagnostic Exercises (http://www.cldavis.org/diag_exercise.html) have been added to the list of activities that provide  recently board-certified ACVP diplomates credit toward their maintenance of certification.

The Diagnostic exercises will now fall under the 'Published peer-reviewed case report' category and will provide 6 credits for first author and 3 credits for each co-author.

This is a recognition to the great job done by the LCPG and the DTF and all the contributors, who for the past 10+ years  have been publishing periodically diagnostic exercises.

Please consider submitting your diagnostic exercise to diagnostic_exercise_submission@list.cldavis.org.

The template to prepare DE is attached here. For additional information and to see the past DEs, please, refer to http://www.cldavis.org/diag_exercise.html. The template for submission of cases is also attached here. It is necessary that the answer sheet is sent to us concurrently with the submission form.

  DE_Submission_form.doc (277.0 KiB, 109 hits)

Please do not hesitate to contact me (claudioslbarros@uol.com.br) if you have any questions.

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Scrambling for CE? - our friends at the Joint Pathology Center have provided 12.5 RACE accredited CEUS in association with the 2019-2020 WSC.

Each set of results (25 in all) and accompanying 5 question self-assessment is worth 0.5 CEUS.

There are a couple of ways to get your CEUs - you can download (or view) the full results (it’s 611 pages, so don’t print it!) and the tests are after each set of results here: - http://www.askjpc.org/wsco/wsc/wsc19/WSCProceedings2019-2020.pdf

Or you can download all of the self-assessments here - http://www.askjpc.org/wsco/SelfAssessment.php and go through the individual cases here: http://www.askjpc.org/wsco/index.php

..Whichever works better for you.

Scan the set when you are done and send them to me at these two emails: bruce.h.williams.dvm@gmail.com (I’m working at home right now( and bruce.h.williams12.civ@mail.mil (my office email for record keeping) so I can grade and send you your RACE certificate!

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Did you know that the Foundation has made a Spanish Translation of Gardiner and Poynton's Metazoan Parasites in Tissue Section available on its website for FREE as a .pdf?

You can find it at: http://cldavis.org/PDFs/atlas_esp.pdf If you are looking for the softbound version of this book in the original English, these are available for only $40 (plus shipping) at the Foundation's online bookstore (https://store.cldavis.org) and you will be supporting the Foundation's many global initiatives!

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The Foundation is very proud to announce the publication of a brand-new, absolutely FREE e-book explaining gross (macroscopic) description entitled "Opening Pandora's Box", by Drs. Paul Stromberg, Dr. Dan Rissi, Dr. Claudio Barros, and with minimal contribution (explained in the preface) by Bruce Williams.

This beautifully illustrated e-book is available to view online at http://www.cldavis.org/pandora or available for download in multiple electronic formats including .PDF, .epub, .azw3 (Kindle) and .mobi at: http://cldavis.org/pandora/ebooks.html

Chapters include Gross Description of Tissue Changes, Interpretation of Tissue Changes, Writing a Pathology Report, as well as an informative preface, introduction, and postface. The text is illustrated by over 80 beautiful gross images.

We believe this is going to be a fantastic help for pathology trainees, veterinarians, veterinary students, and anyone wishing to improve their gross descriptive skills.

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Information from the Joint Pathology Center:

The JPC IT department is working on replacing the old Flash-containing Aperio Imagescope with an upgraded product which is not based on Flash (Leica's Eslide).

At this juncture, not all slides are back online, and it may be a long slog as each case at this point has to be updated manually in the database.  We have identified the urinary system (currently the system being reviewing int he JPC curriculum) and this year's WSC as the priorities, and other systems and years of WSC will follow.

In addition, the current configuration requires a username ("guest") to enter, but leave the password blank.

Our IT staff is currently working in this issue and we will provide periodic updates.

If you are not familiar with the Joint Pathology Center's (JPC's) Wednesday Slide Conference, it is weekly slide conference (well 25 weeks a year) in which over 125 institutions submit two cases and writeups each year.  Now in its 65th year, the results are a fantastic trove of information on pathology of all types in all species.  They are always available via the JPC at https://www.askjpc.org/wsco/index.php.

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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 and targeted consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

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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.

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EMA consultation: Veterinary concept papers and guidelines

The European Medicines Agency has published for public consultation the following concept papers and guidelines:

• Concept paper on the development of a guideline on determination of the need for a maximum residue limit (MRL) evaluation for biological substances
  (Deadline: 30 September 2021)

This concept paper addresses the need for a guideline on determination of the need for an MRL evaluation for biological substances, when it is intended that those substances are included in products for use in food-producing species. According to Annex I Section I.7 of Commission Regulation (EU) 2018/782, the European Medicines Agency (‘Agency’) is requested to publish guidance in order to determine whether there is the need for an MRL evaluation for these substances. Biological substances for which it is concluded that an MRL evaluation is not required shall be published by the Agency in a list of such substances. As immunologicals are exempted from the need for MRL assessment according to Article 1 point 2 (a) of Regulation (EC) No 470/2009, this guidance concerns ‘biologicals, other than immunologicals’ only.

The standard assessment approaches currently used for MRL and consumer safety assessment do not always adequately match assessment requirements for biological substances and may need to be adapted. This concept paper describes and discusses the basis for new guidance in this area.

• Concept paper on the development of a guideline on the environmental risk assessment of veterinary medicinal products intended to be used in aquaculture
  (Deadline: 31 October 2021)

The Committee for Medicinal Products for Veterinary Use recommends drafting a "Guideline on the environmental risk assessment of veterinary medicinal products intended to be used in aquaculture". The guideline will provide clear guidance on how to perform an ERA for VMPs intended to be used in aquaculture. The impact of the guideline for industry, regulatory authorities and other interested parties is therefore considered to be high, as it will reduce the current regulatory uncertainty and disharmonisation while simultaneously ensuring an increase of public and animal health/welfare as well as environmental protection.

• Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products (Deadline: 30 September 2021)

This is the first revision of the Guideline on the summary of product characteristics for anthelmintics, which initially came into effect in February 2008. The main aim of the revision is to take into account the evolution of antiparasitic resistance in the EU and the scientific knowledge on the factors that significantly influence resistance development.

The scope has been further extended to host species other than ruminants and horses, e.g. pigs, poultry and companion animals. The revision takes into account, in particular, the need to shift from systematic to more targeted and medically justified antiparasitic treatment, specific issues in relation to combination products, and the necessity for an accurate dosing. Besides, recommendations as to the justification of pack sizes are included. The guideline intends to be sufficiently flexible, keeping in mind the variability in host and parasite species, in product formulations and in treatment objectives.

• Guideline on clinical trials with immunological veterinary medicinal products - (Deadline: 29 October2021)

The main aim of the guideline is to advise on how to perform clinical trials (also called field trials) with immunological veterinary medicinal products (IVMPs) and to address the requirements of the Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council regarding clinical trials for IVMPs.

In addition, guidance is provided on when omission of clinical efficacy data may be acceptable.

This guideline replaces the Note for Guidance ‘Field trials with veterinary vaccines’ (EMEA/CVMP/852799-Final).

• Guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances - (Deadline: 29 October 2021)

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC introduces specific provisions for applications under exceptional circumstances (Article 25).

The general aim of this guideline is to define minimum data requirements for the demonstration of quality, safety and efficacy of immunological veterinary medicinal products (IVMPs) for applications submitted under Article 25 of Regulation (EU) 2019/6.

It is the intention of the guideline to provide comprehensive guidance on the essential requirements for such applications.

A summary of possible reductions in data requirements for applications for IVMPs under exceptional 47 circumstances is presented in the Annex of this guideline.

• Guideline on data requirements for vaccine platform technology master files (vPTMF) - (Deadline: 29 October 2021)

The main aim of the guideline is to address the type of data to be included in a vaccine platform technology master file (vPTMF). Furthermore, the guideline addresses the omission of information and /or possible reductions on data requirements for subsequent dossier submissions for marketing authorisations (MA) based on a vPTMF  after its first evaluation and certification.

Comments should be provided using this  template and sent to vet-guidelines@ema.europa.eu by the indicated deadlines.

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EMA communication: Use of antibiotics in animals is decreasing

We would like inform you of the latest report published by the European Food Safety Authority (EFSA), the European Medicines Agency and the European Centre for Disease Prevention and Control (ECDC), which says that the use of antibiotics has decreased and is now lower in food-producing animals than in humans.

Taking a One Health approach, the report from the three EU agencies presents data on antibiotic consumption and development of antimicrobial resistance (AMR) in Europe for 2016-2018.

The significant fall in antibiotic use in food-producing animals suggests that the measures taken at country level to reduce use are proving to be effective. Use of a class of antibiotics called polymyxins, which includes colistin, nearly halved between 2016 and 2018 in food-producing animals. This is a positive development, as polymyxins are also used in hospitals to treat patients infected with multidrug-resistant bacteria.

The picture in the EU is diverse – the situation varies significantly by country and by antibiotic class. For example, aminopenicillins, 3rd- and 4th-generation cephalosporins and quinolones (fluoroquinolones and other quinolones) are used more in humans than in food-producing animals, while polymyxins (colistin) and tetracyclines are used more in food-producing animals than in humans.

The link between use of antibiotics and bacterial resistance

The report shows that the use of carbapenems, 3rd- and 4th-generation cephalosporins and quinolones in humans is associated with resistance to these antibiotics in Escherichia coli infections in humans. Similar associations were found for food-producing animals.

The report also identifies links between antimicrobial consumption in animals and AMR in bacteria from food-producing animals, which in turn is associated with AMR in bacteria from humans. An example of this is Campylobacter spp. bacteria, which are found in food producing animals and cause foodborne infections in humans. Experts found an association between resistance in these bacteria in animals and resistance in the same bacteria in humans.

For more related content, please click here.

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The European Medicines Agency has published, for public consultation, six modules of the draft guideline on veterinary good pharmacovigilance practices (VGVP):

• Veterinary pharmacovigilance communication
• Signal management
• Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files
• Glossary
• Controls and pharmacovigilance inspections
• Collection and recording of suspected adverse events for veterinary medicinal products

Comments should be provided using this  template and sent to Vet-Guidelines@ema.europa.eu by 5 September 2021.

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 and targeted consultations.

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The European Medicines Agency has published for public consultation the following veterinary concept papers and guidelines:

• Concept paper for the revision of residues guidelines to align with the definitions for withdrawal periods provided in Regulation (EU) 2019/6

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC entered into force on 28 January 2019 and is applicable from 28 January 2022 onwards. Article 4 of this regulation introduces a new definition for withdrawal period (WP), differing from the definition currently used in residues guidelines. This new definition triggers a revision of the relevant residues guidelines.

Deadline for comments: 31 July 2021

• Guideline on data requirements for vaccine antigen master files (VAMF)

The main aim of the guideline is to address the data to be included in a vaccine antigen master file (VAMF) for veterinary vaccines. Guidance is provided on the data for active substances (antigens) to be included in a VAMF. The guideline includes scientific requirements for the submission, the evaluation and certification of VAMFs.

Deadline for comments: 30 September 2021

• Concept paper for the revision of the guideline on requirements for production and control of immunological veterinary medicinal products

Rev. 1 of the guideline provided information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). Rev. 2  outlines important items related to the quality, safety and efficacy parts of the marketing authorisation dossier that were not sufficiently defined in the requirements of Annex I of Directive 2001/82/EC and the European Pharmacopoeia.

Deadline for comments: 30 September 2021

• Guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines

The main aim of the guideline is to address the use of a multi-strain dossier for inactivated vaccines against antigenically variable viruses or bacteria and to provide information on criteria for eligibility to use the multi-strain approach and on data to be included in a multi-strain dossier. Due to the extension of the multi-strain approach to viral diseases in addition to avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) and to bacterial diseases requiring a need for rapid or frequent change in the strains included in the final product, a revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against AI, BT and FMD was necessary.

Deadline for comments: 30 September 2021

Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by the indicated deadline.

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 and targeted consultations.

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We would like to share with you our recent communications on COVID-19 vaccines as at 22nd June 2021:

COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality

COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis

EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome

EMA advises against use in people with history of capillary leak syndrome

EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17

Using real-world data to monitor Covid-19 vaccines in Europe: joint EMA/ECDC initiative

Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine

International regulators and WHO address need to boost COVID-19 vaccine confidence

All the latest updates on COVID-19 vaccines and treatments are available by clicking here.

We also take this opportunity to highlight our new webpage on Website outages and upgrades, where you can see when our website will be unavailable and find a list of the main improvements made during previous upgrades.

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The European Medicines Agency has published for public consultation the following documents on herbal medicines:

• Public statement on Saccharomyces cerevisiae CBS 5926 - Draft
• European Union herbal monograph on Taraxacum officinale H. Wigg., radix - Draft
• European Union herbal monograph on Vaccinium macrocarpon Aiton, fructus - Draft

Deadline for comments: 31 August 2021.

Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.

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The European Medicines Agency has published for public consultation a draft EU VICH adverse event report implementation guide.

This document aims to support stakeholders in the implementation of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC1 (‘the Regulation’), by providing guidance on the technical specifications and the process of transmission of adverse event reports (AERs). It is targeted at all stakeholders responsible for submitting AERs electronically to the Union Pharmacovigilance Database.

Comments should be provided using this  template and sent to vetchange.programme@ema.europa.eu by 4 August 2021.

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 and targeted consultations.

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We are pleased to inform you that the EMA has published its academia collaboration matrix action plan that sets out how the Agency intends to create closer ties with academics and researchers in the next two and a half years.

It lists actions in five areas identified in EMA's Regulatory Science Strategy to 2025:

• Regulatory science and partnerships;
• Innovation and support to academia;
• Communication;
• Events strategy;
• Trainings.

Highlight actions of 2021:

• Development of the EMA Regulatory Science Research Agenda

Consult the action plan: 

• https://www.ema.europa.eu/en/academia
• https://www.ema.europa.eu/en/partners-networks/academia#framework-for-collaboration-section

To learn more about how EMA interacts with academia, please click here.

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Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation

On 21 April 2021, the EMA Management Board during its extraordinary meeting confirmed that it has verified that the clinical trial EU Portal and Database meets the agreed requirements following an independent audit of this new IT system.

We would like to take this opportunity to thank everyone involved for their continued support in this development as we work together now to ensure a successful go-live and implementation of the Clinical Trial Regulation. Your valuable contribution throughout the years has enabled us to achieve this major milestone and we are looking forward to continuing our close and fruitful collaboration.

As a next step, the Board will inform the European Commission of this outcome. Once satisfied that the conditions set by the Clinical Trial Regulation have been met, the European Commission will publish a notice in the Official Journal of the European Union and six months after this publication, the Clinical Trial Regulation will start to apply and CTIS will go live. It is the desire of the Board, EMA and European Commission that the system goes live on 31 January 2022, which would imply that the Commission notice in the Official Journal would be published on 31 July 2021.

For further details, please see the news published on our website:

https://www.ema.europa.eu/en/news/clinical-trials-information-system-reaches-major-milestone-towards-go-live-application-clinical

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EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy  for the next five years, following its recent adoption by the HMA and EMA Management Board.

The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

“The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” said Emer Cooke, EMA’s Executive Director. “Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programs and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”

The European medicines agencies network strategy to 2025 outlines six priority areas for the network:

• the availability and accessibility of medicines;
• data analytics, digital tools and digital transformation;
• innovation;
• antimicrobial resistance and other emerging health threats;
• supply chain challenges; and

• the sustainability of the network and operational excellence.

The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.

For more details and related content please click here.

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The European Medicines Agency (EMA) has developed a secure online platform for submitting and managing scientific advice applications. From 19 October 2020, EMA will require scientific advice applicants to use the IRIS | Regulatory & Scientific Information Management Platform to manage scientific advice processes with EMA. The below described procedures are intended for future academics applying for Scientific Advice and concern:

• Human domain: Initial and Follow-up Scientific Advice, Initial and Follow-up Protocol Assistance, Initial and Follow-up Qualification Procedure
• Veterinary domain: Initial and Follow-up Scientific Advice

IRIS will provide a single space for applicants to submit and manage information and documents related to their scientific advice applications. This is expected to reduce the time needed to prepare and submit applications and ensure better data quality through integration with other EMA systems. It will allow applicants to check the status of their applications from any device, and to receive automatic status-update notifications.

To begin using the platform from 19 October 2020, it is extremely important that scientific advice applicants follow these preparatory activities in advance of the launch.

Registration steps

Please complete the registration steps below before attempting to carry out any activity relating to scientific advice using the IRIS platform. You may find it helpful to refer to the quick interactive guide to IRIS registration process which provides a summary of registration actions in order to ensure that:

1. You have an active EMA account.
2. Your organisation is registered in EMA’s Organisation Management Service (OMS). It can take from five to ten working days to update or register a new organisation.
3. You have the appropriate user access role and affiliation to an organisation. IRIS user roles are requested in the EMA Account Management portal .

To be able to submit your scientific application via IRIS you will also need to ensure that:

1. You have a valid EMA customer account number, which is a unique reference number for financial matters required to submit scientific advice applications.
2. You have a valid Research Product Identifier (RPI) that EMA uses to track medicines through pre-authorisation procedures. Requests for new RPIs, including requests for transfers of RPIs, are submitted via IRIS. In cases, where a request for RPI also requires registration of an active substance in the EMA’s public list of substances this may take up to five working days.

IRIS registration steps are explained in detail in the IRIS guide to registration.

For further questions, please contact the IRIS project team at iris@ema.europa.eu

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We would like to inform you that the Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020-21. With the European Medicines Regulatory Network focused on the response to the COVID-19 pandemic, the workplan aims to progress evolution to data-driven regulation through smart working, leveraging collaboration with stakeholders and the use of remote expert workshops.

In the past three years, EMA and HMA have led a thorough assessment of the challenges and opportunities posed by big data in medicines regulation. This culminated in January 2020 with the publication of recommendations for regulators to evolve their approach to data use and evidence generation.

Following this preparatory work, the Big Data Steering Group was established in February 2020 to advise the EMA Management Board and HMA on implementing ten priority recommendations.

Its first workplan, published today, aims to increase the utility of big data in regulation from the quality of data through study methods to assessment and decision-making. It foresees closely involving patients and is guided by advances in science and technology. Other stakeholders will also be involved and the workplan intends to leverage international collaboration. Stakeholders will have the opportunity to discuss the workplan and its implementation in the context of a virtual multi-stakeholder forum scheduled for late 2020.

Big data are extremely large, rapidly accumulating datasets captured across multiple settings and devices, for example through wearable devices and electronic health records. Coupled to rapidly developing technology, big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The rapidly changing data landscape forces regulators to evolve and change the way they access, manage and analyse data and to keep pace with the rapid advances in science and technology.

The work carried out by the Big Data Steering Group builds on the Regulatory Science Strategy to 2025, published in March 2020, and will support the European Medicines Agencies Network Strategy to 2025, currently under development.

The European Medicines Regulatory Network has to prioritise the unprecedented public health challenge of the COVID-19 pandemic and implementation of the Big Data Steering Group workplan will need to be flexible and certain actions may need to be re-scheduled depending on the development of the pandemic.

For more information on big data, please click here.

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The EMA is pleased to inform you about the decision to waive all fees for scientific advice for academic researchers developing orphan medicines, to further encourage the development of treatments for rare diseases.

The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with a potential to benefit patients with rare diseases.

Early interaction with EU regulators is important for academia to understand the regulatory requirements and allow the generation of robust evidence needed to establish the medicines’ benefits and risks. This helps them to navigate the regulatory process and ultimately to translate their discoveries into authorised, patient-focused medicines.

Eligible applicants will include public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations. These entities should not be financed or managed by private for-profit organisations in the pharmaceutical sector or have concluded any agreement with pharmaceutical companies concerning their sponsorship or participation to a specific research project for which a fee exemption is sought.

Please check the news item on the EMA’s website, or view the dedicated posts on Twitter and LinkedIn for more information regarding the academic fee waiver.

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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.

This is your last chance to renew your membership of the BSTP for the year 1st April 2021 - 31st March 2022 to avoid incurring the late payment fee!

Please renew before midnight on 30th April 2021 to avoid a late payment charge of £25.00

On behalf of the BSTP Council I would like to thank you for your continued support of the BSTP, without our members, the society would cease to function - put simply, you make what we do possible.

Can you believe that it’s almost been 12 months since you last renewed and during that time, in spite of the pandemic, your membership has enabled the BSTP to continue with its core aims and allowed us to bring forward some new initiatives:

1. Through due diligence of the Council, the BSTP have been able to continue to function as a relevant society within the industry without significant financial losses to the society
2. With the combined efforts of Council and the EduSubCom, although we could not meet F2F for the Annual Scientific Meeting and AGM, we held our first virtual Annual General Meeting in November which was attended by 47 people.
3. Working with other organisations, we have been able to organise webinars to help you maintain your CPD.

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Going forward, CES 3:  Carcinogenesis and CES 4:  Respiratory System will take place as Zoom meetings in March and July 2021 respectively, and if you are looking for CPD credits to update your portfolio, the Royal Society of Biology has awarded 54 CPD credits for each of these CES – a total of 108 CPD credits if you attend both symposiums!

Over the last year we realise that it has been difficult to benefit from your membership with the BSTP.  Now that we are able to organise virtual events and are aiming that next year we can at least meet F2F for the Annual Scientific Meeting, we would like to ask you to please consider renewing now and arranging your payment by bank transfer as soon as possible - your early renewal will help us continue this year’s programming.

Due to increasing costs for online membership renewal and credit card payments, it has been decided to revert back to a ‘paper’ renewal form with the preferred option for all payments made by Bank Giro Credit/Faster Payment/Bill Payment/Bank Transfer/International Payment.  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 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.

A credit card payment system is being trialled, if you prefer to use this option, please contact the BSTP Secretariat - bstpoffice@aol.com

  BSTP 2021/2022 Membership Renewal Form (225.8 KiB, 72 hits)

Please note:

• Before returning your completed form and making the payment, please check whether you have an existing direct debit or reoccurring bill payment set up and ensure that it is for the correct amount.
• If you have more than one existing direct debit or reoccurring bill payment to the BSTP, please ensure that only one transfer is made from your account to the BSTP, and cancel any further transfer of funds.
• To reduce administrative costs, any duplicate payments received will be considered as a donation to the society and not refunded.

 

Council are committed to ensuring that subscription fees cover the majority of the Governance costs and are pleased to advise that there will be no increase to the fees in the current financial year.  The journal costs must also be met by those subscribing, so the fees in 2021 will remain at:

£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)

The membership renewal form is also available as a .doc form, available on request.

The BSTP now has Emeritus membership for those of you that are fully retired from working toxicological pathology, please contact the BSTP Secretariat for further information.

On behalf of Council, I do hope that you renew your membership of the BSTP and I look forward to seeing you at events over the coming year.  Make sure to let us know if you have any suggestions. We’d love to hear your feedback!

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.

 

The ESTP would like to ask you to submit papers and/or a thesis on toxicologic pathology for this years ESTP publication award.

We ask for nominations of impactful Thesis or Publications in the field of toxicological pathology that were published throughout
2018 - 2021. Applications for the award will be evaluated by the ESTP award committee, and the best thesis/paper will be honored with 1.500 Euro.

Last year`s congress was postponed including the award announcement. The award will be presented at the virtual 2021 Cutting Edge/ESTP annual meeting, September 15-18, 2021. It is mandatory that the recipient attends the awards ceremony. The admission fee for this meeting will be waived. The recipient will be notified in July.

The deadline for submission will be June 1st, 2021.

Please send your proposals to the head of the ESTP awards committee: Prof Dr. Johannes (Hans) Harleman - (johannes.harleman@gmail.com)

Toxicologic Pathology is pleased to announce the publication of a special issue in 2022 focusing on The Pathobiology of Nonhuman Primates

Toxicologic Pathology is the premier journal in the field and reaches the leading authorities and decision makers. This is your opportunity to educate these leaders on innovations and to promote yourself as an industry leader.

Published manuscripts are searchable through MEDLINE and will be hosted perpetually on the journal's website. Manuscripts will be e-published upon acceptance.

Please login to the members only area for more details.

 

A new guiding principles document from LASA Education Training and Ethics Section and the RSPCA Animals in Science Department

Delivering the ethics learning outcomes in module 2 for personal licensees:

The aim…

Delivering - and assessing - the ethics learning outcomes in personal licensee (PIL) training courses is an important component of licensee training, but this has never been easy.  There are now defined ‘ethics learning outcomes’ for Module 2, but these do not go into detail about the aims of this aspect of the course, the topics to include, or the approach to take. Students often have no background in ethics or do not understand what ‘ethics’ is (and is not). Furthermore, ethics is not 'black and white' and ethical dilemmas are open to personal interpretation.  Students may also have beliefs and opinions that can be deeply rooted and dictated by culture (e.g. religious, national, regulatory, institutional) or the attitudes of their peers.

The Guidance is divided into two parts.

The first deals with general principles:  the overall aim of ethics training; what ethics is in practice and why it is important; how it relates to the use of animals in research; and the principles underlying good practice in teaching this topic. It emphasises the benefits of ‘normalising’ ethics by showing how it pervades other aspects of science and life generally, focusing on the need for a relevant and practical approach that integrates ethics throughout the whole training course.

The Guidance also deals with some common misconceptions. For example, ethics is often just equated with implementing the 3Rs and improving animal welfare.  However, although both these issues concern the reduction of overall animal suffering and are thus a factor in ethical decision making, ethics encompasses a much wider set of considerations and reflection about what it is justifiable to do to animals in the name of science.

Part two focusses on the practical aspects of delivering the ethics learning outcomes. It is set out in tabled form with the key points to get across for each learning outcome set alongside ideas on how these could be delivered, emphasising the importance of illustrating the training with up to date and local examples wherever possible. There are some handy summary ‘dos and don’ts’, suggestions for development of training resources and opportunities for CPD (e.g. via the AWERB).

The Guidance is available to download from both the LASA and RSPCA websites at:

https://www.lasa.co.uk/current_publications/

science.rspca.org.uk/-/other-papers-and-articles

The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions) is a joint initiative of the STP, ESTP, BSTP and JSTP to develop an internationally accepted nomenclature for proliferative and non-proliferative lesions in laboratory animals.

The Nonproliferative and Proliferative Lesions of the Rat and Mouse Hematolymphoid System is now available - to access a copy, login to the members only area of the BSTP website and click on INHAND

The non-rodent species documents are progressing into membership review.

Because the various rodent systems have been published over several years, some common terms used in pathology were not consistent across the organ systems.  For example, some systems used “thrombus” and some used “thrombosis”.  The Global Editorial and Steering Committee (GESC) undertook a comprehensive review across all rodent organ systems.  Modifications to provide better consistency were recommended and reviewed by the rodent organ working groups.  In addition, an effort was made to harmonize with the ongoing SEND (Standard for Exchange of Nonclinical Data) initiative with the FDA.

The updates to the terms across all rodent organ systems can be seen by accessing goRENI then by clicking on the “Post-publ. changes” under “goRENI members” on the left side of the page.

If you need assistance with access to the goRENI system, please contact Rupert Kellner (rupert.kellner@item.fraunhofer.de).

If you have comments you would like to convey directly to the GESC, please contact the chair of the Charlotte Keenan (charlotte.keenan@msn.com).

Toxicologic Pathology is pleased to announce the publication of a special 2021 issue focusing on Digital Pathology, Tissue Image Analysis, Artificial Intelligence, and Machine Learning in the context of Toxicologic Pathology and Drug Development. This collection of peer-reviewed original research articles and reviews will address multiple topics required for proficiency in these fields.

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.

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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.