Date :
Place : United States, San francisco
Contact Person:Paula Edwards
Description:
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness.Deadline for abstracts/proposals : 6th November 2017
Organized By :New York Events List
Keynote Speakers : Michelleanne Bradley has worked in Drug Safety and Pharmacovigilance in a variety of roles. She has been the “Pharmacovigiliance department of one” with three organizations and counting. Her specialty is consulting with small companies as they start Drug Safety/Pharmacovigilance departments.
Conference Highlights :Understand the FDA and EMEA’s requirements for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes: Develop a high-level PV audit strategy Identify the PV activities and processes subject to PV audit Develop risk assessment criteria Identify the PV audit universe – entities subject to PV audit
Venue :San Francisco, CA, United States
Check the event website for more details.