DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/kn462t/veterinary) has announced the addition of the "Veterinary Pharmacovigilance: Including an Update on Volume IXb - What you Need to Know to Comply (Course, London)" conference to their offering.
The Veterinary Pharmacovigilance course will take place on the 24 & 25 September 2014 at the Harrington Hall Hotel, London
Volume IXb is the key document on Pharmacovigilance guidelines used by the Veterinary regulatory authorities. The purpose of this course is to examine the new aspects and impacts of Volume IXb for Pharmacovigilance Inspections, compliance, adverse event reporting, and the roles and responsibilities of the Company and of the European Qualified Person for Pharmacovigilance in terms of safety assessments in the European Union. It will also discuss detailed guidance on how SARs should be handled, the requirements of PSURs and Pharmacovigilance Inspections.
The new Volume IXb provides greater clarity to old issues, as well as detailing a number of new aspects for the Pharmacovigilance Professional to contend with. There are many new areas to be considered in Volume IXb and this seminar will provide an excellent opportunity to understand the implications of the changes.
TOPICS TO BE ADDRESSED:
- The Role of the Marketing Authorisation Holder
- The European QP for Pharmacovigilance (PV)
- Adverse Event Reporting
- Requirements for Periodic Safety Update Reports
- Company-Sponsored Post-Authorisation Safety Studies
- Literature Searches
- Signal Detection
- Benefit-Risk Assessments
- Risk Management/Minimisation
- Crisis Management
- Communication with the Public
- Pharmacovigilance Inspections and Competent Authorities
WHO SHOULD ATTEND
Personnel in the veterinary industry from the following departments: Research and Development, Veterinary Services, Adverse Reaction Monitoring, Regulatory Affairs and Registration. Qualified Persons, Drug Safety Officers and all those involved in the daily practice of pharmacovigilance within the EU will find this seminar beneficial.
Participants will receive a course material folder containing comprehensive documentation provided by the seminar leader, which will be a valuable source of reference for the future.
A Certificate of Attendance for Professional Development will be given to each participant who completes the course
For more information visit http://www.researchandmarkets.com/research/kn462t/veterinary
Source: Research and Markets