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Speakers

Team Collaboration • Documentation • Data Standards • Submissions • Presentations

April 26-27, 2018
  • Washington, DC

Stephen Amato, PhD, MBA, RAC
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

Catherine Carlisle Leonard
Communications Lead
3D Communications

Stephanie DeChiaro, RAC
Director, Regulatory Affairs
Novo Nordisk Inc.

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC;
Industry Representative, FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

Kevin P. Malobisky, PhD, MS, RAC
Senior Vice President, Regulatory Affairs, Quality and Pharmacovigilance
Karyopharm Therapeutics Inc

Jennifer McNary
Board Member, Beauhawks Foundation;
Manager, J McNary Consulting

Mike Sweeney
Senior Vice President, Clinical Development
Resverlogix Corp.

Dr. Steven M. Weisman
Head, Clinical and Regulatory Support
Innovative Science Solutions LLC

Elijah Wreh
Regulatory Affairs Manager, Invacare Corporation;
Industry Representative,
FDA Advisory Committee Neurological Devices Panel

Stephen Amato, PhD, MBA, RAC
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University

Ayse Baker, PhD, MBA
FRAPS Head of Regulatory Affairs
Chugai Pharma USA, Inc

Catherine Carlisle Leonard
Communications Lead
3D Communications

Stephanie DeChiaro, RAC
Director, Regulatory Affairs
Novo Nordisk Inc.

Michelle Lott, RAC
Principal and Founder, Lean RAQA Systems, LLC;
Industry Representative, FDA Device Good Manufacturing Practices Advisory Committee (DGMPAC)

Kevin P. Malobisky, PhD, MS, RAC
Senior Vice President, Regulatory Affairs, Quality and Pharmacovigilance
Karyopharm Therapeutics Inc

Jennifer McNary
Board Member, Beauhawks Foundation;
Manager, J McNary Consulting

Mike Sweeney
Senior Vice President, Clinical Development
Resverlogix Corp.

Dr. Steven M. Weisman
Head, Clinical and Regulatory Support
Innovative Science Solutions LLC

Elijah Wreh
Regulatory Affairs Manager, Invacare Corporation;
Industry Representative,
FDA Advisory Committee Neurological Devices Panel