Continuing Education credit or Certificate Program units are not available for the archived offering.
In July 2012, new pharmacovigilance legislation became effective across the EU as a result of changes set out in:
• Regulation (EU) No1235/2010
• Directive 2010/84/EU
The legislation is underpinned by an EC Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice. Are you confident your pharmacovigilance operations will meet the EU’s latest expectations for compliance? Do you understand the processes needed to perform adequate risk assessment?
Not knowing which systems and processes you must have in place for the new European pharmacovigilance requirements could have significant consequences for your product. Be sure you have the techniques you’ll need to work to EU standards and have implemented regulatory requirements for signaling and risk management.
This two-part webinar series is designed to give pharmaceutical and biologic companies operating in the EU an introduction to the new European pharmacovigilance requirements.
This archived webinar is available through July 19, 2013.
- EU regulatory framework
- Timeframe for implementation of the new legislation
- GVP modules and implementing measures
- PV System Master File (PSMF)
- Audit and inspection
- ADR reporting
- Periodic Safety Update Reports
- Signal management
- Risk Management Plans: risk assessment and risk minimization
- Implications for international harmonization topics
Who Should Attend
Professionals involved in:
- Drug safety and pharmacovigilance
- Regulatory affairs
- Clinical development
- Executives (including C-Level) with an legal responsibility for drug safety
At the conclusion of this webinar, participants should be able to:
- Discuss the new EU regulatory requirements for drug safety
- Describe how to process adverse events to meet EU requirements
- Explain what to expect in a European PV inspection
Click here for minimum system requirements.