Organizations that Deal with Pharmacovigilance and Drug Safety – Part 1

Dec 12, 2012

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

In an earlier post, we talked about the Uppsala Monitoring Centre (www.who-umc.org) in Sweden.  This is the major organization (outside of governments) that deals almost purely with drug safety.  Also in an earlier session we talked about Motherisk ( http://www.motherisk.org/women/index.jsp) at the University of Toronto, Canada.

There are many other organizations that deal with pharmacovigilance (PV) drug safety (DS) in one way or another.  Some do training and run courses; others hold periodic meetings; some are aimed at rookies and others at more experienced PV personnel.  Many of the organizations (e.g. DIA and ISPE) have job/career information and sites on their websites where employers can post jobs and candidates can post resumés.

Today we will review several organizations that deal in one way or another with drug safety which personnel doing drug safety may find useful.  This list is not meant to be exhaustive and there are most likely some organizations I have not included.  Readers should feel free to respond with information on other offerings.  Most of the courses and meetings noted below are quite pricey ($1000 or more).  In a later post we’ll review educational offerings in DS/PV.

Drug Information Association (http://www.diahome.org)

This is the non-profit, non-commercial, neutral, global organization for the pharmaceutical world.  Members include government, industry, academe and others.  They run courses around the world on risk management, drug safety, pharmacovigilance, epidemiology, regulatory affairs, signaling and more.  Courses are run regularly in the US, EU and Asia though there are occasional courses in Latin America and elsewhere.  They also do on-site training. They run a meeting every year in January in Washington, DC on PV which draws senior PV personnel and FDA both as speakers and attendees.

DIA has multiple publications including the Drug Information Journal which often has DS/PV articles.

DIA offers a certificate in clinical safety and PV.  http://www.diahome.org/en/Meetings-and-Training/About-our-offerings/Certificate-Programs/ClinicalSafetyandPharmacovigilanceCertificateProgram.aspx

The DIA Annual Meeting in June in the US every year also runs a PV/DS track with presentations on relevant topics.  There are also PV/DS topics found in other tracks such as IT, clinical research, regulatory etc.  So one must scan the catalog of sessions very carefully.

The courses are usually prepared by the instructors and thus the content is a function of the skill set of the instructor.  Full Disclosure: I am a co-instructor in the US pre and post marketing courses run in Horsham and Boston as well as the instructor in the how to survive a PV audit course.  Thus, excluding my courses, I have found that the meetings & courses I have attended have been well done.

One note of warning.  Their website is very difficult to navigate.  There does not seem to be, incredibly, a search box on the home page.  I often have to do a search on key words at the google site to find what I need.

The International Society of Pharmacoepidemiology  (ISPE) www.pharmacoepi.org

As its name suggest, this society is primarily dedicated to the use of pharmacoepidemiology in public health and medicine.  Unlike several of the other groups noted in this post, ISPE is involved not only in scientific information exchange and education but also in policy development and advocacy.  They note that this includes PV, drug utilization research, outcomes research, comparative eeffectieness research and therapeutic risk management.

Clearly pharmacoepidemiology, databases, data mining, outcomes research etc. is on the cutting edge of DS and PV these days.  (If I were 20 years younger I’d go back and get a degree in pharmacoepidemiology.  It looks like that is where the jobs in our field will be found in the next several decades).

It is a global and fairly senior level, specialized organization in the field of DS/PV.  They usually hold an anuual meeting and a mid-year meeting at various venues around the world.  The 2013 mid-year meeting is in Munich, Germany in April and the annual meeting in Montreal in August.

They publish a newletter (Scribe) and a journal (PDS).

They have an excellent global listing of educational programs in pharmacoepidemiology (http://www.pharmacoepi.org/resources/educational_programs.cfm).

This is an excellent organization and anyone involved in pharmacoepidemiology would be well advised to be involved with this group.

The International Society of Pharmacovigilance (ISoP)  (http://www.isoponline.org/)

This is a non-profit organization whose secretariat is in the UK.  It originally started its existence as the European Society of Pharmacovigilance but globalized some years ago.  Unfortunately, their impact and membership in the US is relatively small though they are trying to expand in the US and Canada.  They are now starting a US chapter.

They hold annual meetings (none yet in the US though the last was in Mexico) in interesting and sometimes not easily accessible venues.  The senior players in drug safety from Europe and elsewhere are involved and the meetings and organization are solid and useful.  They have run occasional training courses.

Their major impact is as the publisher of their official journal Drug Safety.

It is hoped that this organization will extend its global range to include the US as well as the other major and emerging players in drug safety.  Their website is clear and well navigable.

The Drug Safety Research Unit (DSRU) www.dsru.org

The DSRU located in Southampton, England is an excellent research and education organization.  They have done pioneering work in PV over the years and their major effort now involves Prescription Event Monitoring which is a unique system developed in the 1980s.  In a nutshell, it involves GPs in the UK sending in information on drugs they prescribe and on adverse events seen (whether felt due to the drugs or not).  This observational data is used for studies on safety of new (and old) drugs.  The data, the DSRU notes, is useful for hypothesis generation as well as quantitative analyses and comparative studies of drug safety signals.  They are exceedingly active and have over 250 publications listed on their website.

The DSRU runs a very active training schedule with roughly one course a month (at least for the first half of 2013) in the UK.  They also offer a postgraduate certificate, diploma and Masters in PV.

The DSRU is primarily aimed at the UK and the EU and much of their coursework is thus UK/EU directed.  There are discussions about expansion into the US and elsewhere. Their website is clear and useful.

Regulatory Affairs Professionals Society (RAPS) www.raps.org

RAPS is actually, as its name obviously states, is primarily a regulatory affairs organization.  They do touch on drug safety occasionally, usually in the context of Good Clinical Practices and regulations.  They have an extensive training and education section but little in regard to drug safety or pharmacovigilance.  They offer certification in regulatory affairs.  Their website is clear and easy to navigate.

Conclusions

As you can see there clearly is not one single organization that is the leader in the field of drug safety and pharmacovigilance.  Several are useful.  DIA has lots of drug safety content and many educational programs but is not a DS/PV organization.  ISoP is such an organization but is less advanced in the US and in its training and educational offerings.

In Part Two we will look at organizations that offer training (in particular in DS/PV) as their main raison d’être.

As noted at the beginning, if any of our readers have additions or suggestions, they are most welcome.