DUBLIN, April 8, 2016 /PRNewswire/ --
Research and Markets has announced the addition of the "Advanced Pharmacovigilance (London, UK - September 28-30, 2016)" conference to their offering.
(Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO )
This course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.
Key Topics to be Covered:
- Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
- The DDPS retirement and the New PV Master file in the EU
- Compliance and Drug Safety
- Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
- Developing Company Core System Information CIOMS III
- Safety Reporting in Licensing Agreements
- PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
- Implications for Safety Reporting in Global Clinical Trials
- Risk/Benefit Determinations
- Risk Management Plans
Why you should attend:
- Expand your global safety knowledge
- Enhance your team's capabilities and compliance in both the regulations and your company's expectations
- Help ensure you build and maintain a quality Pharmacovigilance department ready for any Pharmacovigilance inspection
- Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspection
For more information visit http://www.researchandmarkets.com/research/nhzv38/advanced
Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
SOURCE Research and Markets
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
Newsrooms &
Influencers
Digital Media
Outlets
Journalists
Opted In
Share this article