[ACVM] Discussion topic:

[Craig Reinemeyer]

Folks, 
As one of the parasitology "new kids on the block", I'm a little hesitant to offer my opinions because I'm not sure they are relevant to those members with expertise in the more traditional ACVM disciplines.  However, I'll post the following suggestion because I think it is sufficiently generic to apply to all of our disciplines.  

There are useful precedents for a boarded specialty to increase its impact on the veterinary profession, and provide extremely useful information in the process.   For years, the ACVIM has been publishing "consensus statements" or focused reviews.  I've attached one example for your consideration, and the guidelines for such papers are clearly stated in the opening paragraph.  (True, the ACVIM has its own organ for publication, but numerous journals would welcome similar material on infectious diseases.)   Generally, these papers are written by a team of interested experts, and then reviewed by a publications committee within ACVIM before submission.  This degree of expertise and the College "consensus" support really give these papers rigor and authority, and  I could see a ton of similar works coming out of ACVM just in the fields of emerging diseases, zoonotic threats, etc.    

The common complaints I've seen in the recent ACVM posts suggest that our members feel they are laboring alone, with dubious administrative support, and don't feel they have much impact.  Well, consensus statements would be one way to tell the world that you're here, you know a ton of important stuff, and you're willing to share your knowledge with practitioners and academic clinicians for the betterment of animal health.   Lots of us are working "one deep" at our home institutions, and it's difficult to maintain enthusiasm without a critical mass.   Virtual collaboration among experts from different disciplines, working on a focused topic, would be a great way to create and solidify relationships within our membership.  

Best wishes,  CRR 


Craig R. Reinemeyer, DVM, PhD, Dipl. ACVM
President, East Tennessee Clinical Research, Inc. 
80 Copper Ridge Farm Road
Rockwood, TN  37854
(865) 354-8420
creinemeyer at easttenncr.com 



 





-----Original Message-----
From: ACVM_diplomates [mailto:acvm_diplomates-bounces at lists.osu.edu] On Behalf Of Tim Frana
Sent: Monday, January 11, 2016 6:58 PM
To: ACVM - The American College of Veterinary Microbiologists Listserv <acvm_diplomates at lists.osu.edu>
Subject: [ACVM] Discussion topic: Pharmacovigilance

Hi all,

Would like to pose the following for discussion:

In September 2015, the USDA APHIS published a proposed rule in the Federal Register regarding standards for pharmacovigilance.  In essence, the proposal would require veterinary biologics companies to record and submit reports concerning adverse events associated with the use of biological products, primarily vaccines. Currently, veterinary biologics companies are required notify APHIS if there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product. However, there is no specific guidance related to adverse event reports. These requirements would align APHIS with guidelines outlined by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). While the comment period for this proposal has closed, there will likely be opportunities for public input on pharmacovigilance for veterinary biological products in the future. Should ACVM provide comment on the need for the proposed requirements? If so, how should that be done? Examples: through AVMA Council on Biologics and Therapeutic Agents (COBTA), writing a position paper, supporting workshops or meeting presentations.  Issues related to the proposal but not specifically addressed include how to analyze and use data from adverse event reports and how to convey the information to the public. Is this area of vaccinology one in which ACVM can/should be involved or considered outside our area of expertise?

Appreciate any comments.

Thanks,
Tim Frana
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