Organizations that Deal with Pharmacovigilance and Drug Safety – Part 2 Training & Education

Dec 19, 2012
Bart Cobert

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

In an earlier post, we talked about organizations that deal with drug safety.  In this post, we will talk about organizations that do training and education in drug safety and pharmacovigilance.  Some are academic, non-profit and others are companies that specialize in training and education as their business.  This list is not complete and if any of our readers know of other institutions, particularly outside the US, please do indeed drop a note in the comments section of this blog.  I have avoided mentioning any of the commercial outfits.

Only a disappointingly small handful of institutions offer programs in drug safety and PV.  Many others offer programs in pharmacoepidemiology which touch on drug safety but whose primary focus is epidemiology.  And, of course, one can find many institutions globally that offer degrees and certificates in epidemiology.  One should note that courses and degrees in the US are aimed primarily for a North American audience whereas those in the EU are aimed more at EU/EMA pharmacovigilance.  Although there are similarities, obviously, laws and requirements differ by region and country.  Some offer distance learning.

The University of Medicine & Dentistry of New Jersey (UMDNJ)’s School of Health Related Professions has a program known as the “Biopharma Educational Initiative” which is a 100% web-based system.  http://shrp.umdnj.edu/dept/biopharma/index.html.   All work is done on–line (No need to come to New Jersey…). They offer several certificate based programs usually 5 courses each in clinical research and, of interest to us, Drug Safety & PV.  The courses here include Regulatory & Ethical Requirements in Clinical Investigation; AE Reporting & Postmarketing Activities; Principles of PV, Regulations & DS Reporting plus a choice of two electives out of four offered including Overview of Disease Processes & Treatment; Risk Management Tools, Clinical Pharmacology or Nutrition & Pharmacology; Analyzing Clinical Data to Determine AEs.  Full disclosure: I am an Adjunct Associate Professor here.

See the website: http://shrp.umdnj.edu/dept/biopharma/certificates.htm

In addition, they offer Masters Degrees in four areas including DS & PV: There are nine courses plus a Graduate Project required.  See the website for details: http://shrp.umdnj.edu/dept/biopharma/certificates/courses-rev.htm#safety

Temple University in Philadelphia offers a 36 hour Certificate in Global Pharmacovigilance at their Pennsylvania and New York State sites as well as corporate sites.  Courses required include: Post-Marketing Safety Surveillance; Clinical Drug Safety and Pharmacovigilance; Good Pharmacovigilance Operations,

Pharmacoepidemiology; The Regulatory and Legal Basis of Pharmacovigilance;

Benefit-Risk Management of Healthcare Products. See:http://www.temple.edu/pharmacy_qara/pdf/GlobalPharmacovigilance_brochure.pdf

As noted in the earlier post, the Drug Safety Research Unit (DSRU) in the UK offers certificates, diplomas and Masters in pharmacovigilance.  See: http://www.dsru.org/trainingcourses/accredited_qualifications1  As with other EU courses, this is aimed primarily at an EU audience.

The University of Hertfordshire in Hatfield, UK offers short courses and distance learning leading to a MSc degree.  See: http://www.herts.ac.uk/courses/PharmacovigilancePG_details.cfm

The London School of Hygiene and Tropical Medicine offers a certificate in pharmacoepidemiology and pharmacovigilance.  It is a 20 week course with 80 hours of formal teaching, 80 hours of self-directed study and 70 hours of project work.  See: http://www.lshtm.ac.uk/study/cpd/scpp.html

Also in Europe the Eu2P offers a Masters Degree and Certificates in pharmacovigilance and pharmacoepidemiology.  It is aimed primarily at an EU audience.  The Eu2P training partnership is composed of seven Universities, the European Medicines Agency, the French Medicines Agency and fifteen Pharmaceutical Companies from the European Federation Pharmaceutical Industries Association (EFPIA). The Université of Bordeaux Segalen is the coordinating institution for the whole Eu2P program.  See: http://www.eu2p.org/

The Uppsala Monitoring Centre (UMC), as noted in the last posting, offers courses in pharmacovigilance.  They also publish a listing of other institutions that offer training and courses around the world: http://www.who-umc.org/DynPage.aspx?id=116850&mn1=7347&mn2=7252&mn3=7323&mn4=7633

The Drug Information Association (DIA) offers a certificate in drug safety.  It requires 16 core and 16 elective units.  This is a combination of on-line training and on-site training (Horsham, Boston, Washington).  They also offer short courses in DS/PV and have on-site corporate training.  Full disclosure: I teach in this program.  See: http://www.diahome.org/en/Meetings-and-Training/About-our-offerings/Certificate-Programs/ClinicalSafetyandPharmacovigilanceCertificateProgram.aspx

The Pharmaceutical Education & Research Institute (PERI) is a non-profit organization dedicated to scientific and technical training.  It is located in Arlington, VA.  They also offer on-site training.  Full disclosure: I have taught in their courses.  They offer short courses in drug safety and pharmacovigilance during the year.  See: http://peri.org/

MedDRA: There are courses offered around the world on MedDRA coding both by private institutions as well as by the MSSO.  See their website: http://www.meddramsso.com/public_training.asp

There are many other commercial institutions that offer training.  They are found on the Internet.  I have no experience with most of them and cannot speak to their quality, accreditation, usefulness etc.  I will not list them here.  You can find them by doing a Google search with the key words: training, pharmacovigilance. Caveat emptor.

Some comments on DS/PV training.

As you can see, this posting is woefully short.  There are, in fact, only a very small number of institutions that offer training to health care professionals (and others) in drug safety and PV.  Training in this area is almost non-existent in medical schools, nursing schools and other medical professional schools.  Only schools of pharmacy seem to have any sort of training and even there it is still largely undeveloped.

Obviously, drug and device adverse events are a major public health issue.  The concepts are almost universally misunderstood by the public (All drugs approved for sale are “safe and effective”, right?).  Health care professionals do understand that drugs are a double-edged sword but have almost no practical training.

There is a shortage of skilled educators in drug safety and PV.  Although certificates and now, Masters/PhD degrees, are being developed, the consistency and quality of the training are hard to judge.  There is no accepted “core curriculum” of knowledge required to do skillful and professional drug safety/PV.  Although one would think academia would recognize this need and attempt to fill the void, we are really not seeing this.

So when you look for a training program, look at the institution offering the courses, degrees and certificates, the qualifications of the trainers, the books and journals used for training, whether you will be tested (Yup, painful though it is, testing usually enhances learning) and whether commercial interests are sponsoring the training.  As stated above: caveat emptor.