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Guidance on training and CPD for Information Officers
December 2019 Page 1 of 2 NATIONAL COMMITTEE FOR THE PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSES: GUIDANCE ON TRAINING AND CPD FOR INFORMATION OFFICERS (IOs) Some IOs will have already been involved in the HPRA regulatory system and will already have completed formal training in their previous posts, so there may be no additional training needed., It is recommended that at least the modular training in the legislation, ethics and 3Rs be completed: - EU Education and Training Framework - Module 1: Legislative framework; - EU Education and Training Framework - Module 2: Ethics, animal welfare and the 3Rs (Level 1); this will help to obtain an understanding of legal and ethical aspects of use of animals for scientific purposes and also covers the concepts and principles of the 3Rs; - EU Education and Training Framework - Module 50: Introduction to the local environment (establishment), which gives a good understanding of the local structure for management and responsibility relating to animal use at your establishment; and - EU Education and Training Framework also suggests that the IO completes aspects of Module 51 - Information provision and retrieval., You may wish to extend your skills by: - Spending time reviewing the NC3Rs website and the links within it; - Completing a suitable training module covering how to search, source, retrieve and store information; methods of searching; (e.g. see links to FRAME or SYRCLE in the Resources Section of the Guidance on the Role of the Information Officer document); - Receiving other training on information searching, storing and retrieval; - Spending time in discussion with knowledge management experts (e.g. information technologists, librarians); - Completing EU Education and Training Framework - Module 9: Ethics, Animal Welfare and the Three Rs (Level 2), a component of PPL training, which may be useful in extending the basic knowledge of ethics and legislation; - Attending a specific IO training course - if/when developed; - Visiting animal facility(s); - Attending topic specific LASA/LAVA/IAT/NC3Rs/RSPCA/UFAW meetings; and - Undertaking soft skill training; 1., Diplomacy December 2019 Page 2 of 2 Extract from EU Document – Education & Training Framework Initial training Training should include searches for information and strategies for dissemination: - LO 2.13: Describe relevant sources of information relating to ethics, animal welfare and the implementation of the 3Rs; - LO 51.1: Be aware of different search tools (e.g.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/training-and-cpd-for-io.pdf?sfvrsn=d4526218_2Advice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract
Opinion from National Committee for the Protection of Animals Used for Scientific Purposes 3 October 2018 Request for advice: A request for advice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract was submitted to the NCPAUSP from the HPRA., Advice: The Committee considered the definition of procedure under Article 3 of Directive 2010/63/EC, and also in particular to the specific practices which are exempt from such control under paragraph 5 of Article 1 of that Directive, especially subparagraphs (a) {“non- experimental agricultural practices”}, (d) {“practices undertaken for the purposes of recognised animal husbandry”}, and (f) {“practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice”}., A number of these Member States referred to the control of such practices by other legislation, such as animal welfare legislation., The remaining Member State stated that while the practices fell outside the scope of the Directive, its national legislation required such practices to have a permit due to the national definition of animal research., The Committee is also aware that protection for the welfare of such animals already exists in law, for which purpose the Animal Health and Welfare Act 2013 created a duty on the organisers of such training to protect the welfare of the animals involved.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/advice-relating-to-certain-training-courses-covering-bovine-artificial-insemination-(ai)-and-ultrasound-scanning-of-the-bovine-reproductive-tract.pdf?sfvrsn=a406518_2Report of the Meeting on 15 May 2024
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 15 May 2024 1., Matters Arising The Committee noted that since the last meeting a brochure detailing ‘Tips for effective Animal Welfare Bodies’ and another ‘An introduction to Animal Welfare Bodies’ has been published in hard and soft copy., The Committee will re-engage with national Animal Welfare Bodies to review how best to address their needs in the future. 7., European network of Animal Welfare Bodies The Committee was informed about the establishment of a European network of Animal Welfare Bodies (ENAWB) in April 2024.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-15-may-2024.pdf?sfvrsn=8491475f_1The 3Rs
The 3Rs The 3Rs represent the principles of Replacement, Reduction and Refinement, forming a compassionate framework for animal research., These principles are the foundation of EU and national legislation concerning the protection and welfare of animals used in science, encompassing domestic as well as wild animals and birds involved in research projects., Refinement Minimising suffering and enhancing animal welfare in studies., Ensuring careful animal handling by trained researchers, providing anaesthesia and pain relief during procedures, maintaining high standards of housing and husbandry, including access to toys and nesting material., Further information on the 3Rs Alternatives A look at alternative approaches to animal testing and some useful resources from EU bodies.
https://www.hpra.ie/regulation/scientific-animal-protection/the-3rsOnline contact form
Category* - Select - Medicines for human use Medicines for animal use Scientific animal protection Medical devices Cosmetics Blood, tissues and organs Controlled drugs Other Topic* - Select - Clinical trials Summary of product characteristics / Product information leaflets Interchangeable substances query Manufacturer query Method of Sale and Supply of a Human Medicine Other queries Reporting an issue / side effect query Requesting a New National submission slot Requesting Ireland to act as Reference Member States (RMS) Scientific advice Shortages Submitting an application to the HPRA Wholesaler / Retailer query Topic* - Select - Regulatory query Reporting an issue / side effect / adverse incident query Safety query Veterinary clinical trials Sub-topic* - Select - Copy of GMP certificates Exempt medicines query General query Topic, * - Select - Application process Classification process Compliance query Existing authorisation holder National Committee Other queries Scientific animal welfare Sub-topic - Select - How to submit an application for authorisation How to pay a fee Sub-topic* - Select - Individual authorisation query Project authorisation query Topic* - Select - Registration query Regulatory query Reporting a safety issue query Safety query Certificates of free sale Topic*: - Select - General query Reporting an issue / side effect query Topic*: - Select - Compliance query Reporting an issue / serious adverse reaction query Vigilance query Topic* - Select - Accessibility query Finance query Careers Data protection Events at the HPRA Freedom of information General query Invoice, query Media query MyAlerts subscriptions query Parliamentary questions Protected disclosures Report an illegal activity Website administrator query ---------------- - Select - Report a side effect - medicines for human use Report a quality defect - medicines for human use Report a side effect or adverse incident – medicines for animal use Report a safety issue for a medical device Report a side effect – cosmetic product Report a serious adverse reaction/event – tissues and cells Innovation office enquiry Medical devices economic operator – registration form Please provide details of your query* Please attach file (if relevant) This field is required Complete this online form to contact the HPRA with your query.
https://www.hpra.ie/contact-us/online-contact-formMake a Submission | Application forms and other forms to send to the HPRA
View list Medicines for animal use View the list of forms and download relevant forms for completion and submission., View list Scientific animal protection View the list of forms and download relevant forms for completion and submission.
https://www.hpra.ie/make-a-submissionReport of the meeting on 09 October 2024
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 09 October 2024 1., The event aims to highlight the benefits of Replacement and provide a platform for discussion between researchers and those directly involved in animal research., European network of Animal Welfare Bodies The Committee was informed that as there is not a national AWB network in Ireland.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-09-october-2024.pdf?sfvrsn=f5cd8e5d_1Report of the Meeting on 12 September 2023
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 12 September 2023 1., Animal Welfare Body brochure and poster An update to the Brochure developed previously by the Committee for Animal Welfare Bodies (AWB) was agreed in principle., AOB The Committee noted the reports of a PARERE workshop in Italy on 30-31 March 2023 as well as a recommendation of a subgroup of EU National Committees on non-animal derived antibodies dated 7 July 2023.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-12-september-2023.pdf?sfvrsn=74cc43ba_1NCPA tips for AWB - A4 Poster
Tips fo r e ffe c t i ve Animal We l f a re Bodies Everyone’s responsibility The AWB Planning on joining the AW B ?, Read ‘A n I n t roduction to Animal We l f a re Bodies’* Get to know your AW B - who is on it and what they do!, Fa m i l i a r i s e yourself with any existing 3Rs repositories within your establishment Keep abreast of new 3Rs developments and opportunities Introduce all members and explain their background and roles Compose and implement a Culture of Care mission statement Fo ster open communication Listen to everyone – seek input from all involved, and at all levels Everyone’s voice is important and should be respected Circulate any lessons learned from ongoing and completed projects to optimise project evaluation Ta ke that tour – visit the unit(s) and speak to users and staff Attend the meetings, have your say and represent others *Issued by the National Committee for the Protection of Animals Used for Scientific Purposes
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/3-ncpa-cnca---a4-poster-2024.pdf?sfvrsn=21c706d_3Guide to cosmetic products for responsible persons changes tracked
As of 11 March 2013, a ban on all animal testing of finished products and ingredients applies, even if there are no alternative non-animal tests., Data on any animal testing performed by the manufacturer, agents or suppliers and any animal testing performed to meet the regulatory requirements of third countries should be Guide to Cosmetic Products for Responsible Persons ADV-G0010-5.1 7/15 included in the PIF., Where no animal testing has been conducted a statement indicating this should be included in the PIF., Therefore, where an animal test has been performed, the following information should be contained within the PIF: - identification of the animal test carried out - identification of the ingredient tested - date of the animal test - location of the animal test - information on the entity (or entities) that carried out the test and the entity that commissioned it - legislative purpose of the animal test and substantiation of the stated purpose In the case of the last point, a clear reference to the legislation in question, a short description of the scope and of the need for the testing under that legislation should be included., The manufacturing premises and equipment utilised should ensure protection of the product, efficient cleaning and minimise the risk of mix-ups, or cross-contamination.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/adv-g0010-guide-to-cosmetic-products-for-responsible-persons-v6-changes-tracked.pdf?sfvrsn=dd42147d_3