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Trk 03: Innov Part Model/Outsourcing [clear filter]
Tuesday, June 28
 

2:00pm

#237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166-000192; RN 1.00

This session will explore key aspects necessary for success when integrating regulatory operations teams as a result of mergers and acquisitions.

Learning Objectives

Discuss the necessary elements for successfully integrating regulatory operations departments during a merger or acquisition; Identify risks related to migrating information between systems; Respond to questions from others in the organization on best practices for integrating regulatory solutions.

Chair

Sarah Powell, RAC

Speaker

Challenges and Business Impact Associated with Mergers and Acquisitions
Meredith K Sewell

Building a Regulatory Information Management Capability for the Next Decade: People, Process, and Technology - Case Study
Dominique E. Lagrave



Chair
avatar for Sarah Powell

Sarah Powell

President, Powell Regulatory Services
Sarah has over 29 years of experience in pharmaceutical and related regulated industries. Most recently, Sarah has worked on assisting clients with projects related to process improvements, standards development, defining filing strategies and writing and review of submission content... Read More →

Speakers
DL

Dominique Lagrave

Director, Global Regulatory Affairs and Safety Operations, Amgen
Dominique has over 20 years of international regulatory affairs experience with the last 15 years spent in global regulatory operations management. Since 2015, Dominique is a Director at Amgen where he is leading the global regulatory operations organization with responsibility for... Read More →
MS

Meredith Sewell

Director, Global Regulatory Publishing, Allergan
Meredith Sewell is Allergan’s Director of Global Regulatory Affairs Operations and leads the Publishing, RIM and Archiving functions. Meredith joined the company in Irvine, CA in 2006 and in 2015, after Allergan merged with Actavis, Forest, Watson & Warner-Chilcott, she now leads... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies
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... 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... 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... Read More →


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