Issues & Methods Schedule 2011
Issues & Methods Schedule 2010
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Events:
Issues & Methods Roundtable Topics 2011
Date
Topic
Facilitator
Coordinator
January 11
Complaint Handling in US, Europe and Canada in the Medical Device and Drug Industry.
Evangelia Evdaimon & Edie McMillan
Evangelia Evdaimon
February 8
Challenges in creating and implementing Standard Operating Procedures
Evangelia Evdaimon
Evangelia Evdaimon
March 8
Internal Audits – What is their value?
Edie McMillan
Evangelia Evdaimon
April 12
Quality for CROs - Minimum requirements for compliance and managing customer pressures
Jenny O’Brien
Evangelia Evdaimon
May 10
Labeling Requirements for all prescription drugs
during Clinical Trials.
Anita Simkins
Evangelia Evdaimon
June 14
Proposed Regulations, Draft Guidances or other FDA changes in 2010 - 2011
Evangelia Evdaimon
Evangelia Evdaimon
July 12
Selecting an IRB – Quality considerations.
Tabitha Westbrook
Evangelia Evdaimon
August 9
Quality for Phase I CROs – Special considerations.
Edie McMillan
Evangelia Evdaimon
September 13
Post marketing studies regulatory requirements, scope and use.
Lisa Olson.
Evangelia Evdaimon
October 11
Examples cases of Regulatory Enforcement and Criminal Investigations and how could they have been prevented?
John Janeri
Evangelia Evdaimon
November 8
Benefits & Challenges of auditing Service Providers.
Beth Furr
Evangelia Evdaimon
