Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
311
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
253B
CHAIR
:
Janel Demeter, (SCHNON), Manager, Regulatory Operations, Accenture LLP, United States
Janel is responsible for the management of regulatory submission projects bringing 12 years of life sciences experience. Her current focus is on ensuring client projects are in compliance with global regulatory requirements.
SPEAKER
(S):
Janel Demeter, (SPKNON), Manager, Regulatory Operations, Accenture LLP, United States
Janel is responsible for the management of regulatory submission projects bringing 12 years of life sciences experience. Her current focus is on ensuring client projects are in compliance with global regulatory requirements.
Sunitha Reddy Nalla, MS (SPKNON), Associate Director, Regulatory Operations, Aveo Pharmaceuticals, Inc., United States
She has over 18 yrs of industry experience combined between Regulatory and IT. Roles and responsibilities include defining and participation in strategic Regulatory Affairs agency submissions, Records Management and Technology initiatives.
Aaron Miller, (SPKNON), Alliance Manager, Labeling & Submissions Management, Janssen Research & Development, LLC, United States
9 years experience with Janssen Research & Development, LLC. Expertise in publishing, production, and vendor management within the Labeling & Submissions Management organization in JRD.
Description
This session will focus on the value proposition of outsourcing the life cycle management of your eSubmission documents. It will harness expertise and best practices based on hands-on knowledge, past problems solved, and developing a strategic approach to the submission process to prevent issues before they happen. This session will include a case study focused on applying the large pharma model to small pharma companies and include details of a specific client engagement and lessons learned. It will also illustrate best practices, and perceived barriers and solutions based on experience. Discussions will also focus on what you should expect out of your strategic outsourcing partnership.