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Diplomate in Safety Pharmacology (DSP)
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2019 Examination Date and Location: September 22, 2019
Centre de Convencions Internacional de Barcelona
Safety Pharmacology Society is an international nonprofit organization that promotes knowledge, development, application, and training in Safety Pharmacology—a distinct scientific discipline that integrates the best practices of pharmacology, physiology, and toxicology.
The objective of Safety Pharmacology studies is to further the discovery, development, and safe use of biologically active chemical entities by the identification, monitoring, and characterization of potentially undesirable pharmacodynamic activities in nonclinical studies. The Safety Pharmacology Society also supports the human safety of drugs and biologicals by fostering scientific research, education, and dissemination of scientific information through meetings and other scientific interactions.
The Safety Pharmacology Society has established a process for certification which would evaluate and document competency in the field of Safety Pharmacology. There is a need from the industry, and regulators worldwide for a certification process to confirm expertise and identify quality standards for professionals involved in the practice of safety pharmacology.
The advantages of establishing a certification for Safety Pharmacologists is that it stimulates recognition of the discipline in the overall drug development community and with regulators, encourages toxicologists and other professionals who wish to diversify their experience and professional expertise to participate in SPS activities, and stimulates poster presentations and publications in safety pharmacology.
- Be a current SPS Member
- Register for the Exam, and pay the examination fee: $250
- Achieve a passing grade on the DSP certification examination (see below);
- Currently have earned at least a bachelor degree in science
- Have at least two years of relevant experience in positions involving safety pharmacology
- Have at least one poster on safety pharmacology as first author presented at a recognized major (national or beyond) scientific meeting
- Examination registration deadline: September 1
- Exam results are sent to candidates in January
The Certification Exam
Certification is achieved by success on the certification examination. The exam is a written exam, conducted in English. Each examination consists of four one and a half hour parts (see agenda below).
The exam will contain approximately 200 multiple choice questions covering the following areas of safety pharmacology (approximate distribution):
- Regulatory guidelines (10%)
- Safety pharmacology systems
- Cardiovascular safety pharmacology (30%)
- Electrophysiology (20%)
- Hemodynamy and contractility (10%)
- Neurological safety pharmacology (20%)
- General neurological evaluations (15%)
- Drug abuse potential (2%)
- Seizure liabilities (3%)
- Respiratory safety pharmacology (15%)
- Renal safety pharmacology (5%)
- Gastrointestinal safety pharmacology (5%)
- Other systems (5%)
- Cross discipline knowledge (10%)
Still not sure if you should take the exam? Take our sample exam and see how you do!
- Check-in begins at 09:00
- Lunch will be provided
- The exam begins at 09:15, and ends at 16:30 (start and end times subject to change)
- View sample agenda
Examination Requirements and Rules
- Candidates must present photo ID, be preregistered, and sign a waiver prior to entering the examination room. Onsite registrations will NOT be accepted.
- Small quantities of snacks and beverages are permitted within the examination room.
- All tablets and cell phones must be on silent and are prohibited to use while taking the exam
- Breaks will be given after each section of the four part exam (see agenda), if you must take a break outside of the scheduled time, you must turn in your exam and you will not be able to complete the unfinished portion of that section/part of the exam.
Withdrawal or Illness
If you need to withdraw from the exam due to illness, personal reasons, or fail to appear for the exam there is no refund and the fee is nontransferable to future years. If you miss the exam due to illness or fail to appear for the exam, you will be eligible to register for the following year’s exam and will be required to pay the appropriate exam fee upon registration.
Training and Preparation for the Exam
Suggested Study Materials include:
DSP Webinar series: Focused Reviews in Safety Pharmacology (Part 1, 2, 3) on Vimeo
(please contact SPS Headquarters for the password; You must be an SPS member in order to gain access to the recorded webinar series)
Download slides on our Webinars page (2013).
All scientific articles related to the scope of the examination presented above published in the following journals:
- Journal of Pharmacological & Toxicological Methods
- Regulatory Toxicology and Pharmacology
- British Journal of Pharmacology
- Journal of Cardiovascular Pharmacology
- Journal of Applied Toxicology
- Cardiovascular Toxicology
- Expert Opinion on Drug Safety
- Toxicology and Applied Pharmacology
- Fundamental and Clinical Pharmacology
- Guyton and Hall textbook of Medical Physiology, 13th Edition, John E. Hall, PhD, 2016
- Principles of Safety Pharmacology (Handbook of Experimental Pharmacology), Michael K. Pugsley and Michael Curtis, Editors, 2015
- Nonclinical Assessment of Abuse Potential for New Pharmaceuticals, Carrie Markgraf, Thomas Hudzik, and David Compton, Editors, 2015
- Electrocardiography of Laboratory Animals, Jeffrey W. Richig and Meg M. Sleeper, 2013
- Textbook of Veterinary Internal Medicine, Stephen Ettinger and Edward C. Feldman, 7th Edition (earlier editions may not have the same chapters)
- Chapters on Electrocardiographic Techniques; Echocardiography; Syncope; Pathophysiology of Heart Failure; Electrocardiography and Cardiac Arrhythmias; Neurologic Examination and Neuroanatomic Diagnosis; Vestibular Disease; and Clinical Approach and Laboratory Evaluation of Renal Disease
For a full list of suggested scientific reference articles to assist in preparation for the exam, please view the DSP Key References.
Results of the Examination
Candidates are required to complete all parts of the exam. Successful candidates are certified and accepted as Diplomates in Safety Pharmacology (DSP). The minimum score required to pass the examination will be determined prior to the examination by the Certification Committee each year based on the results from participants for the year. The scores for the sections passed or failed are not reported to candidates. A participant failing to achieve the minimal score to pass the examination will be invited to take the certification examination at his/her convenience at the next SPS Annual meeting.
Significance of Certification
Certification by the Safety Pharmacology Society indicates only that a person has satisfied the specific requirements of the DSP certification process and program, and is not a guarantee, warranty, endorsement or promise by the SPS of the competency, quality of services provided, accuracy, or of any other particular result with respect to the services rendered or products used by any certified individual. Information about Diplomates is provided by the Diplomates themselves, and the SPS, its officers, directors, employees, volunteers, agents, and authorized contractors/representatives are not responsible for any incorrect or out-dated information about Diplomates, including their office addresses or any other contact information. The SPS does not assume and specifically disclaims any duty or obligation to the public for the services rendered by Diplomates, or for any information about or provided by Diplomates or any other person or entity participating in or receiving professional services from Diplomates of the SPS.
Maintenance of Diplomate Status
- Maintain valid membership of the SPS
- Pay annual Diplomate fees ($75)
- Obtain a total of at least 15 SP “credits” over a three year cycle. Diplomates are required to submit their SP credits every three years, please keep all receipts and acceptance/invitation letters for the following items:
- Attendance at the Annual SPS meeting (5 credits)
- Invited oral presentation on a topic related SP at recognized academic institution or recognized scientific meeting (e.g. SOT, ACT, EUROTOX, etc.) (5 credits)
- Attendance at a scientific meeting related to SP (e.g. SOT, ACT, EUROTOX, etc.) (3 credits)
- Each first author poster presented at a recognized scientific meeting (2 credits)
- Each non-first author poster presented at a recognized scientific meeting (1 credit)
- Publication in the field of pharmacology (10 credits)
- Continuous Education Course, including webinars (1 credit)
The Certification Committee
Questions are written by a certification committee composed of SPS Diplomates. Nomination of members to the certification committee is voted periodically by the Board of Directors of SPS. The committee will be composed of at least three SPS current Diplomates. The committee should include at least at one member with:
- Expertise in cardiovascular safety pharmacology
- Expertise in CNS safety pharmacology
- Expertise in respiratory safety pharmacology
To be eligible for nomination to the committee, candidates should have a minimum of 10 peer-reviewed scientific publications in the field of pharmacology including six in the field of safety pharmacology. If a candidate does not have 10 publications, she/he should submit a written summary of experiences to illustrate her/his expertise in the field of safety pharmacology. Eligibility of candidates submitting a summary of experience will be determined by an anonymous vote by the Board of Directors of the Safety Pharmacology Society in which the majority will be required to allow eligibility.
The committee will prepare a minimum of 100 new questions each year to be added to the question database. New questions will be submitted to Diplomates for review in a private room at the Annual SPS meeting. Diplomates will determine the relevance of the new questions by attributing a score from one to five for each question. New questions that are considered relevant (average score of four or five) will be added to the certification exam the following year.
Questions previously used for the certification examination will be modified by the committee before inclusion in the examination for the following year.
The committee will update the list of scientific references (journals and textbooks) relevant to the preparation of the certification examination for prospective Diplomates. The list of references will be maintained on the SPS website.
List of Diplomates:
(As of January 1, 2019)
- Matthew M. Abernathy, PhD, DSP
- Michael Accardi, MSc, PhD, DSP
- Alexis Ascah, PhD, DSP
- Simon Authier, DVM, MSc, MBA, PhD, DSP
- Marc Bailie, DVM, PhD, DSP
- Ted Baird, PhD, DSP
- Russell Bialecki, MSc, PhD, FSB, DSP
- Brandon Borders, MS, PSM, LAT, DSP
- Alfred Botchway, MSc, PhD, DSP
- Arthur Brown, MD, PhD, DSP
- Kristy Bruse, PhD, DSP
- Jeffrey Burdick, VMD, DSP
- Ray Chui, MSc, PhD, DSP
- Matthew Coffee, BS, DSP
- Michael Curtis, PhD, FHEA, FBPharmacolS, DSP
- Jill Dalton, PhD, DABT, DSP
- Annie Delaunois, DVM, PhD, DSP
- Hector De Leon, PhD, DSP
- Mark Deurinck, DVM, Dr.med.vet, DABT, ERT, DSP
- Mike Engwall, DVM, PhD, DSP
- Kevin Ford, PhD, DABT, DSP
- Beth Geist, DSP
- Andrea Greiter-Wilke, DVM, PhD, DSP
- Thomas Grizzle, MS, DABT, DSP
- Robert Hamlin, DVM, PhD, DACVIM, DSP
- Marci Harter, DSP
- Donald Hodges, Jr., MSc, PhD, DSP
- David Holdsworth, BS, RVT, DSP
- Mary-Jeanne Kallman, PhD, DSP
- Ken Kearney, DSP
- John Koerner, PhD, DSP
- Paul Kruzich, PhD, DSP
- Pierre Lainee, PhD, DVM, DSP
- Morten Laursen, MSc, PhD, DSP
- Derek Leishman, PhD, DSP
- John E. Maggio, PhD, DSP
- Jeffrey McKee, MS, PhD, DABT, DSP
- Monica R. Metea, PhD, DSP
- Dinah Misner, PhD, DABT, DSP
- Tomas Mow, DVM, PhD, DSP
- Dennis J. Murphy PhD, DABT, DSP
- Kevin Norton, DSP
- Kyle O'Donohue, DSP
- Mark A. Osinski, PhD, DSP
- Malar Pannirselvam, MVSc, PhD, DABT, DSP
- Mylene Pouliot, PhD, DSP
- Helen Prior, PhD, FSB, DSP
- Michael Pugsley, MSc, PhD, FBPharmS, DSP
- Yusheng Qu, PhD, DSP
- Will Redfern, PhD, FSB, FBPharmacolS, DSP
- Sonia Roberts, DSP
- Brian M. Roche, PhD, DSP, DABT
- Mike Rolf, PhD, DSP
- Marie Luce Rosseels, DVM, DSP
- John Barry Ross, Jr., MS, RLATG, DSP
- Nataliya Sadekova, DSP
- Jason Segreti, MS, DSP
- Lasse Skibsbye, PhD, DSP
- Matthew Skinner, PhD, DSP
- Maxim Soloviev, MD, PhD, DSP
- Dale Stevens, BS, DSP
- Jeffrey Tepper, PhD, DABT, DSP
- Martin Traebert, PhD, DSP
- Venkatesha Udupa, BVSc, MVSc, MSc, DABT, DSP
- Hugo M. Vargas, PhD, DSP
- Jean-Pierre Valentin, PhD, HDR, ERT, CBiol, FSBiol, FRCPath, DSP
- Kate Voss, BS, DSP
- Bradley Youngblood, DSP
- Tanja Serena Zabka, DVM, DACVP, DSP
Other Education Opportunities
SPS occasionally collaborates with partners to offer discounts to members for educational courses. New opportunities will be listed here when they become available
2019 University of Wisconsin-Madison Distance Academy
Below is an online education opportunity for SPS members who want a better understanding of Cardiovascular Physiology, Pharmacology and Safety. The course is organized and conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison, and is taught by SPS Members!
$200 Discount for SPS members!! Use code 2019SPS at checkout (membership status is verified by SPS Headquarters)
Standard registration: $1050
SPS Member registration: $850
Group registration: $850 each for 2 or more from same company
Cardiovascular Physiology, Pharmacology and Safety: A Practical Review
Knowledge of the cardiovascular physiology, pharmacology, and safety is a key to moving drug projects forward. A drug development scientist must also understand cardiovascular receptor pharmacology. This course will provide pharmacological strategies for management and correction of cardiovascular diseases. You will also learn safety issues associated with the cardiovascular system. At the end of this course, you will have a cardiovascular system “toolbox” at your disposal. This will help you make smart decisions based on proven science and avoid common pitfalls.
This course is part of the Applied Drug Development Certificate. It fulfills one elective. You may take the course as is or as part of the certificate.
The purpose of this course is to provide the learner with a basic review of the fundamental physiological processes of the cardiovascular system and pharmacological strategies for management or correction of cardiovascular diseases. It will also address safety issues associated with drugs affecting the cardiovascular system. Topics covered in this course include:
- Physiological considerations associated with the cardiovascular system including autonomic nervous system, renal and respiratory systems
- Fluid compartments and their regulation; distribution of fluid volumes
- Electrical conduction of the heart (ion channel function and cardiac arrhythmias)
- Cardiac muscle function
- Cardiovascular system function - flow, blood pressure and heart rate; how blood pressure is regulated
- Cardiovascular receptor pharmacology
- Drug exposure to cardiac tissue and vascular system; PK/PD modeling; autoradiography
- Cardiovascular diseases: hypertension, congestive heart failure, ischemia, pulmonary artery hypertension, pharmaceutical-induced dysfunction
- Pharmacological considerations in the treatment of the disease states listed above
- Cardiovascular safety consideration of the development of oncology agents, biologics, RNAi therapy, gene therapy, peptides, small molecules, vaccines, and implantation devices
- Overview of cardiovascular consideration in the drug development process from chemist to market
Upon completion of the pgoram the learner should be able to:
- Describe the physiological regulation of the cardiovascular system and what makes it work;
- Discuss cardiovascular receptor pharmacology;
- Identify the actions of various pharmacological classes of drugs which are associated with the therapeutic management of different diseases;
- Explain the drug development of novel compounds for treatment of heart disease;
- Describe the safety assessment of non-cardiac novel compounds-bringing safe compounds to the market; and
- Apply information in the course through case studies on drug development or post market reconsiderations (eg. Vioxx, Seldane, etc)
Instructors: Kristy D. Bruse, PhD, DSP, Integrated Physiology and Pharmacology Consulting, LLC; Robert Kaiser, PhD, DABT, Principal Research Scientist at Minnesota Children's Hospital, Children's Hospitals and Clinics of Minnesota; and Hugo M. Vargas, PhD, DSP, Scientific Director, Integrated Discovery & Safety Pharmacology, Amgen, Inc
Please visit the course site for additional information