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Changes to Good Pharmacovigilance Practices in the EU
Friday, July 20, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.
Why Should You Attend:
This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012.
The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module, of which the first seven Modules have been disclosed for public consultation. This course will describe the Regulatory Updates, Guidance Updates and thoughts on how some Member States’ Competent Authorities will proceed with implementation. These regulatory changes will also impact the EU Clinical Trial Directive and expectations of sponsors in the protection of patients and public health, before, during and after a clinical study.
Key Topics to be Discussed:
- Pharmacovigilance systems
- Reporting and Management of Adverse Reactions
- Periodic Safety Update Reports
- Post Authorization Safety Studies
- Changes to Definitions
- The Pharmacovigilance Risk Assessment Committee
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.