Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 4: Strategies to Achieve Global Regulatory Operations Excellence

Session Chair(s)

Kevin  Tompkins, MBA

Kevin Tompkins, MBA

Executive Director, Regulatory Information & Submission Management

Bristol Myers Squibb, United States

The present global regulatory environment requires companies to be agile, cost efficient, and effective in their daily operations. Regulatory operations often deal with tight deadlines, last minute changes, and are pushed to accelerate timelines. In order to achieve successful submissions, operations teams need to leverage teamwork, streamlined processes, and effective planning. Focused strategies that facilitate communication and global operations are the foundation for successful submissions. This session will review suggestions and strategies for building a successful team that can tackle the daily challenges teams face while working towards an efficient future state.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify strategies for increasing the efficiency and quality of your regulatory operations team
  • Apply best practices and continuous quality improvement to your global submissions processes
  • Manage initiatives for improved collaboration and resource management


Paul  Miller, MBA

Building a Global Regulatory Operations Team

Paul Miller, MBA

Alnylam Pharmaceuticals, United States

Senior Director, Regulatory Technology, Operations and Filing Excellence

Olga  Alfieri, MBA, MSc, RAC

Working Smarter, Not Harder: The Future of Globalization

Olga Alfieri, MBA, MSc, RAC

Eisai Pharmaceuticals, United States

Senior Director, Global Submission Management & Operations

James  Hendry

Resourcing a Reg Ops Team: Which Model Fits Best for You

James Hendry

GE Healthcare, Pharmaceutical Diagnostics, United Kingdom

Head of Global Regulatory Operations

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.