Research and Markets (http://www.researchandmarkets.com/research/2kmk5v/advanced) has announced the addition of the "Advanced Pharmacoviglance" conference to their offering.
Dates: 16th -18th March 2015
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.
Benefits in 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
Key Topics to be covered:
- Due Diligence
- 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 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
For more information visit http://www.researchandmarkets.com/research/2kmk5v/advanced
