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Tuesday, June 28 • 4:00pm - 5:15pm
#259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The session provides an overview of outsourcing models for regulatory activities to achieve a scalable, flexible model, while decreasing the complexity of internal regulatory affairs activities and assuring full regulatory compliance. Both industry and consultant company perspectives will be shared.

Learning Objectives

Describe the benefits of outsourcing of regulatory activities to allow focus on core strategic aspects of the company; Recognize different models of outsourcing of regulatory activities and how to best apply them to your own business; Identify the key success factors to ensure cost efficient and compliant outsourcing.

Chair

Andrew S. Verderame

Speaker

Regulatory Outsourcing: Consultant Perspective
Andrew S. Verderame

Regulatory Outsourcing: Industry Perspective
Dietmar Boecker, PhD

Outsourcing Life Cycle Management: A Model of Efficiency
Alistair Davidson



Chair
avatar for Andrew Verderame

Andrew Verderame

President, Pharmalex US Regulatory
Andrew S. Verderame, MBA, RAC leads the PharmaLex US staff in providing FDA-specific regulatory guidance and consulting services. PharmaLex clients benefit from his wealth of experience, including leading well over one hundred meetings with FDA, managing multi-site regulatory teams for both large and small pharmaceutical companies, and presenting to FDA Advisory Committees, with successful outcomes. He previously held senior regulatory affairs... Read More →

Speakers
avatar for Dietmar Boecker

Dietmar Boecker

Vice President, Head Regulatory Affairs, Established Products and Intl Dev, Bayer Pharma AG
since 01.01.2016: VP, Head RA Established Products and Int. Development, Bayer Pharma AG | 01.12.2012 - 31.12.2015 Director, RA Marketed Products, Bayer Pharma AG | 01.09.2007 - 30.11.2012 Deputy Director Global Submission Management & Archiving, Bayer AG | 01.08.2001 - 31.08.2007 Associate Director Global Submissions, Bayer AG | 01.09.2000 - 31.07.2001 Manager Medical & Regulatory Operations, Mallinckrodt Medical GmbH | 01.03.1999... Read More →
avatar for Alistair Davidson

Alistair Davidson

Senior Director, Delivery Solutions, Regulatory Affairs, PPD
Alistair is Senior Director, Regulatory Delivery Solutions at PPD, where he is responsible for country regulatory management and strategic development of PPD’s regulatory services globally. He has held senior leadership roles in regulatory affairs in GSK and Quintiles, with a track record of regulatory success with pharmaceuticals, biologicals and vaccines. Alistair has extensive experience in developed and emerging markets, including Europe... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA