Speaker Profile


Peggy J. Berry

MBA, RAC

President & CEO at Synergy Consulting

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development.  She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.  Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).  She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).  In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.  She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

eCTD Submissions of IND/NDA to the US FDA, EU and Canada
eCTD Submissions of IND/NDA to the US FDA, EU and Canada

Speaker:Peggy J. Berry
Time: 12th January 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90215

Fri
12
Jan 2018

FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials
FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials

Speaker:Peggy J. Berry
Time: 18th December 2017 10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Model : GRC-90203

Mon
18
Dec 2017

Packaging and Labeling for Commercial and Clinical Products
Packaging and Labeling for Commercial and Clinical Products

Speaker:Peggy J. Berry
Time: 30th January 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90216

Tue
30
Jan 2018

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