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Spotlight Newsletter

 


Students

SPS offers award opportunities for both Students and Jr. Investigators. For full details, and to apply for these awards, please visit our Awards page.

SPS offers funding opportunities for undergraduate and graduate students to participate in educational training, workshops, meetings, and mentorships to help further their knowledge and career. The goal of this funding is to enable undergraduate and graduate students to engage in additional education and career development opportunities to enhance their personal development.

ELIGIBILITY/CRITERIA:

  • Pursuing a degree (undergrad, graduate) in safety pharmacology, pharmacology, or related disciplines. Advisor/Supervisor of the candidate is not required to be a current member of the Safety Pharmacology Society, but nonmembers are encouraged to apply for membership.
  • The activity can be in any area of physiology, pharmacology, neuroscience or other field related to the discipline of safety pharmacology. Educational activities with direct application to the field of safety pharmacology are encouraged and will be given preference.

The primary selection criterion is the quality of the student and the quality and suitability of the training, workshop, meeting or mentorship request. Recipients of the support will be selected based on their application materials and need for support. We expect to see evidence in the application materials that the candidate has strong interest in the field of safety pharmacology and that the proposed educational activity will help support them in this career path.

TO APPLY:

  1. Submit a support request
    1. Support requests should be one page in length describing the educational activity the applicant wishes to attend, reasons the training will assist them in their career and the learning objectives they anticipate from the activity. In the request, please also mention the support needed and what the support covers (specific dollar amount, maximum $1,000).
  2. Submit a current CV
  3. Submit a letter from your supervisor supporting participation in the activity

All application materials should be submitted to Krystle Correll.

DEADLINE: We realize that training opportunities are held throughout the year, so we have a flexible application deadline. Applications should be received in the calendar year in which you wish to participate in the activity and must be received at least two months prior to the activity start date so the Committee has time to review the request.

AWARDEE RESPONSIBILITIES:

After the activity is completed, awardees will prepare a short summary of the educational opportunity and describe the educational outcomes/knowledge gained from attending the training. Please submit this summary to Krystle Correll within 30 days of completion of the activity along with your expense reimbursement form.

SUPPORT:

We will consider all application requests until the support funds available are used for that calendar year. Applications are reviewed and funds are awarded based on the date of acceptance/submission. We plan to support a maximum of 4 requests at up to $1,000 each per calendar year to support these training requests. Recipients must provide original receipts to SPS and a complete a reimbursement form in order to receive their funds in a timely manner. Those awarded support also receive complimentary membership to SPS for the remainder of the year in which they are granted the funds.

Examples of expenses eligible for funding:

  • Conference, Training course, or Workshop Registrations (SPS Annual Meeting Excluded)
  • Internship or conference travel

Examples of expenses not eligible for funding:

  • Tuition costs, or textbooks at current institution
  • Personal entertainment and incidentals while attending the activity
  • SPS Annual Meeting travel or registration
  • SPS (or other organization) Membership Dues

PDF coming soon


Regulatory Guidance

2010

FDA Draft Guidance on Abuse Liability

2006

EU Guidance on Abuse Liability Assessment

Guidance for Industry: S8 Immunotoxicity Studies for Human Pharmaceuticals—The objectives of this guidance are to provide (1) recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and (2) guidance on a weight-of-evidence decisionmaking approach for immunotoxicity testing. Immunotoxicity is, for the purpose of this guidance, defined as unintended immunosuppression or enhancement. Drug-induced hypersensitivity and autoimmunity are excluded.

2005

Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs—This guidance provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. This assessment should include testing the effects of new agents on the QT/QTc interval as well as the collection of cardiovascular adverse events. The investigational approach used for a particular drug should be individualized, depending on the pharmacodynamic, pharmacokinetic, and safety characteristics of the product, as well as on its proposed clinical use. The assessment of the effects of drugs on cardiac repolarization is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, this document may be reevaluated and revised.

Guidance for Industry: S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals—This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. The guidance includes information concerning nonclinical assays and integrated risk assessments. The assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, they will be evaluated and this guidance might be revised.

2002

Public Health Service Policy on Humane Care and Use of Laboratory Animals—This 2002 reprint of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals reflects the August 7, 2002 PHS Policy amendment permitting institutions with PHS Animal Welfare Assurances to submit verification of Institutional Animal Care and Use Committee (IACUC) approval for competing applications or proposals subsequent to peer review but prior to award (67 FR 51289). New footnotes (6 and 12) are incorporated to provide institutions with the option of coding the names of IACUC members in materials routinely submitted to the Office of Laboratory Animal Welfare (OLAW). Citations and addresses are also updated in this reprint, and language specifying that information be submitted on institutional letterhead or in letter form is eliminated to allow for electronic submission of information to OLAW in the future.

2001

Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals—This guidance was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. This guidance provides a definition, general principles, and recommendations for safety pharmacology studies.

Dutch Ministry of Health, Welfare and Sport (Dutch)

European Union Food Safety
Consumer confidence in the safety of food products has sometimes been shaken in recent years by food-related health crises. Responding to the challenge, the European Union has put in place a comprehensive strategy to restore people’s belief in the safety of their food “from the farm to the fork.” This is based on a combination of high standards for food, animal health and welfare, and plant health. These standards apply both to food produced inside the EU and food imports. Find out more...

Institut De Veille Santitaire (French)

German Federal Ministry for Health (German)

Health Canada
Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.

ILSI Health and Environmental Sciences Institute (HESI)
The Health and Environmental Sciences Institute (HESI) is a nonprofit institution whose mission is to stimulate and support scientific research and educational programs that contribute to the identification and resolution of health and environmental issues of concern to the public, scientific community, government agencies, and industry.

International Conference on Harmonisation: Safety Guidelines
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

International Life Sciences Institute
Founded in 1978, the International Life Sciences Institute (ILSI) is a nonprofit, worldwide foundation that seeks to improve the well-being of the general public through the advancement of science. Its goal is to further the understanding of scientific issues relating to nutrition, food safety, toxicology, risk assessment, and the environment by bringing together scientists from academia, government, and industry.

Japanese National Institute of Health Services
The National Institute of Health Sciences (NIHS) conducts testing, research, and studies toward the proper evaluation of the quality, safety, and efficacy of pharmaceutical products, foods, and the numerous chemicals in the living environment.

Ministry of Health, Labour and Welfare

National Center for Complementary and Alternative Medicine
The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government’s lead agency for scientific research on complementary and alternative medicine (CAM). We are 1 of the 27 institutes and centers that make up the National Institutes of Health (NIH) within the US Department of Health and Human Services. The mission of NCCAM is to: Explore complementary and alternative healing practices in the context of rigorous science., train complementary and alternative medicine researchers., and disseminate authoritative information to the public and professionals.

Office of Laboratory Animal Welfare- Policies and Laws

Organization for Economic and Co-Operation and Development
Established in 1961, the OECD brings together the governments of countries committed to democracy and the market economy from around the world to: Support sustainable economic growth, boost employment, raise living standards, maintain financial stability, Assist other countries’ economic development, and contribute to growth in world trade. The OECD also shares expertise and exchanges views with more than 100 other countries and economies, from Brazil, China, and Russia to the least developed countries in Africa.

Pharmaceutical Information Services
Phorum is a Pharmaceutical Information Portal founded in 1999 by West Point Pharmaceutical Consulting President Dr. Joe Patterson.

UK Department of Health
The aim of the Department of Health (DH) is to improve the health and wellbeing of people in England. About us explains DH’s work, structure and responsibilities.

US Department of Health & Human Services
Office of Extramural Research- Extramural grants are awarded to investigators throughout the US and abroad.

US Food and Drug Administration

The US FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The US FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. US FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. US FDA also ensures that these products are honestly, accurately and informatively represented to the public.

Implementation of the CDISC SEND (Standard for Exchange of Nonclinical Data) standard by sponsors and CROs has picked up significant momentum following draft guidance issued by the FDA in December 2014. This guidance mandates SEND readiness for general toxicology and carcinogenicity studies based on the SEND Implementation Guide 3.0 starting in December 2016 for NDA submissions. Details regarding the FDA’s guidance can be found at www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The PMDA in Japan is also implementing CDISC standards, starting first with SDTM data for clinical trials to be followed by nonclinical studies based on the SEND model.

For more information on this data standard and to provide feedback on the SEND 3.1 Guide, read more at www.cdisc.org/send.


Animals Use in Research

The Safety Pharmacology Society recognizes that scientific and medical knowledge developed through animal research has saved countless lives, has improved human and animal health, and has alleviated pain and suffering. We support the judicious use of animals in research, education, and testing in the interests of human and animal welfare.

Read Complete Statement pdf icon

To learn more about the safe transport of research animals by air and why it is such an important issue, see the transportation statements from a number of national and international organizations in support of human and animal health.

Animal Welfare Information Center

The Animal Welfare Information Center is part of the US Department of Agriculture (USDA) National Agricultural Library (NAL)

The focus of the Center’s information products, services, and activities is to help the regulated community with employee training and to promote the humane care and use of animals by providing information on alternatives (improved methods of animal experimentation which could reduce or replace animal use or minimize pain and distress to animals—the “3Rs”).

American Association for Laboratory Animal Science

The American Association for Laboratory Animal Science (AALAS) is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals.

Association for the Assessment and Accreditation for Laboratory Animal Care International

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International) is a voluntary accrediting organization that enhances the quality of research, teaching, and testing by promoting humane, responsible animal care and use. It provides advice and independent assessments to participating institutions and accredits those that meet or exceed applicable standards.

European Society of Laboratory Animal Veterinarians (ESLAV)—European College of Laboratory Animal Medicine (ECLAM)

The European Society of Laboratory Animal Veterinarians (ESLAV) gives veterinarians a forum to discuss issues which concern them, in the field of laboratory animal science, in general and in Europe specifically. The society's objectives are to promote and disseminate expert veterinary knowledge within the field of laboratory animal science.

The European College of Laboratory Animal Medicine (ECLAM) is a veterinary specialty organization established within Europe for the specialty of laboratory animal medicine (LAM).The primary objectives of the College shall be to further scientific progress in Laboratory Animal Medicine in Europe and increase the competency of those who practice in this field.

Foundation for Biomedical Research

The Foundation for Biomedical Research (FBR) is the nation’s oldest and largest organization dedicated to improving human and veterinary health by promoting public understanding and support for humane and responsible animal research.

Institute for Laboratory Animal Research

The mission of the Institute for Institute for Laboratory Animal Research (ILAR) is to evaluate and to report on scientific, technological, and ethical use of animals and related biological resources, and of non-animal alternatives in non-food settings, such as research, testing, education, and production of pharmaceuticals.

International Council for Laboratory Animal Science

The International Council for Laboratory Animal Science is an international scientific organization dedicated to advancing human and animal health by promoting the ethical care and use of laboratory animals in research worldwide.


National Association for Biomedical Research

The National Association for Biomedical Research (NABR) provides the unified voice for the scientific community on legislative and regulatory matters affecting laboratory animal research. NABR works to safeguard the future of biomedical research on behalf of its more than 350 public and private universities, medical and veterinary schools, teaching hospitals, voluntary health agencies, professional societies, pharmaceutical and biotech industries, and other animal research-related firms.

National Centre for the Replacement Refinement & Reduction of Animals in Research

The National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs) is the UK's national organization which leads the discovery and application of new technologies and approaches to replace, reduce and refine the use of animals for scientific purposes (the 3Rs).

Society of Toxicology

The Society of Toxicology (SOT) is a professional and scholarly organization of scientists from academic institutions, government, and industry representing the great variety of scientists who practice toxicology in the US and abroad. SOT is committed to creating a safer and healthier world by advancing the science of toxicology. The Society promotes the acquisition and utilization of knowledge in toxicology, aids in the protection of public health, and facilitates disciplines.

Other Research Societies and Groups Related to Animals in Research

A Language and Messaging Guide for Scientists Discussing Humane, Responsible Animal Research

  1. Whenever possible, the expression animal research should be preceded by the descriptive adjectives: humane, responsible. Unless you are discussing a rare instance of noncompliance in animal care, or historical research that preceded modern animal care techniques, this is almost always appropriate.
  2. Whenever possible, discuss your need for animals, or your study of animals as opposed to your use of animals. Avoid the phrase “research on animals” in favor of “working with animals.”
  3. The notion that there is an essential need for humane, responsible animal research should be reinforced as often as possible.
  4. Avoid the words experiment, experimenting and experimentation. The anti-research movement prefers these words because they can have a sinister connotation.
  5. Under no circumstances should you repeat the word torture—even if you are accused of it. Animal research is conducted according to humane and responsible standards—it is not a sadistic practice. As a general rule, do not repeat any language used in a false and inflammatory accusation against you.
  6. Do not use the words vivisection or anti-vivisection. Vivisector is a label that animal activists use to make researchers sound cruel and sinister. Vivisection, in fact, is simply an experimental surgery on a living being.
  7. When describing researchers and scientists who study animals, don’t hesitate to use a possessive pronoun, for example, researchers take good care of our animals or researchers take good care of their animals versus researchers take good care of the animals.
  8. Remember that our goal is to promote public understanding, respect, and appreciation for humane, responsible animal research in order to build public acceptance and support for the practice. Our goal is not to promote animal research per se. The difference is very significant and distinguishes scientists and researchers from commercial interests.
  9. Promote the fact that veterinary health and medicine is advanced along with human health and medicine through humane, responsible animal research.
  10. Avoid medical and scientific jargon as well as technical explanations of complex scientific concepts.

APS Guiding Principles for the Care and Use of Animals—American Physiological Society.


Job Bank

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