Adverse event reporting in pigs Ken Steen Pedersen www.oevet.dk
Ø-VET A/S Ø-Vet A/S was founded in 1996 and today consists of 15 people www.oevet.dk
Ø-Vet A/S Farms visited regulary Farms visited ocasionally www.oevet.dk
Veterinarian Ken Steen Pedersen Company: Ø-Vet A/S 2003: DVM, Royal Veterinary and Agricultural University 2003: Swine practitioner, Veterinary assistant 2006: Chief Veterinarian and shareholder, Ø-VET 2011: Diplomate by examination of ECPHM 2012: PhD 2012: Assistant Professor in Pig Diseases 2013: Chief scientist, Pig Research Centre 2015: CEO, Partner, Ø-VET A/S 2015: Affiliated Associated Professor in Pig diseases, University CPH www.oevet.dk
The current situation Not many problems with adverse effects Generally content with current situation www.oevet.dk
Examples of suspected adverse events Reported: Significant visible pathological reaction Significant visible pathophysiological reaction Significant lack of efficacy – specific disease Also important is link between use and event www.oevet.dk
Examples of suspected adverse events Not Reported: Minor visible pathological reaction Minor visible pathophysiological reaction Minor lack of efficacy – specific disease or negative production results Less obvious link between use and event www.oevet.dk
Increased information from vets to regulators on adverse effects More information: When to report events How to report events The level of need documentation needed The benefit for vets, industry and food safty www.oevet.dk
Information regarding the safety and efficacy from regulators to vets Access to raw data from all countries in the EU Electronic system with some level of information to vets www.oevet.dk
Organisation/expert group at EU level www.oevet.dk
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