TMCnet News
Research and Markets: Advanced Pharmacovigilance Course: London UK - 21st, 22nd, 23rd of September 2015Research and Markets (http://www.researchandmarkets.com/research/jhlkx2/advanced) has announced the addition of the "Advanced Pharmacovigilance Course" conference to their offering. This course is designed for those with at least 2 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: - Due Diligence - Training for Drug Safety - Reporting Duties, Audits and Expectations - Risk Based Inspections - The DDPS Retiremnt 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 Safety 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 - Crisis Management within Drug Safety Benefits of Attending: - 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 inspections For more information visit http://www.researchandmarkets.com/research/jhlkx2/advanced
View source version on businesswire.com: http://www.businesswire.com/news/home/20150702005549/en/ |
