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Understanding the Mindset of an FDA Employee
J. Lawrence Stevens, RAC
Consultant/FDA Regulatory Expert
One Way Consultants, LLC
Thursday, 2nd April, 2015
11:30 AM EDT | 04:30 PM CET
FDA's Import Requirements and Managing the Import of FDA Regulated Products
J. Lawrence Stevens, RAC
Consultant/FDA Regulatory Expert
One Way Consultants, LLC
Thursday, 9th April, 2015
11:30 AM EDT | 04:30 PM CET
Executive Update of the US/EU status and opportunities of the new Biosimilars Product Class
Dr. Hoss A Dowlat
Principle Consultant
PharmaBio Consulting
Friday, 17th April, 2015
11:00 AM EST | 04:00 PM CET
FDA Medical Device Regulation - Unique Device Identifier Requirements
Sheila J. Ramerman, RAC
Founder
SJR Associates
Friday, 24th April, 2015
02:00 PM EST | 11:00 AM PST

Complaint Handling in Compliance with FDA and ISO Regulations
Jeff Kasoff, RAC, CQM
Director Of Quality

How To Reconcile ICH GCP With RISK BASED Monitoring Approaches
Dr. Beat Widler
Managing Partner