Speaker Profile

Peggy
Peggy Berry
President & CEO, 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).

Upcoming Webinars Recorded Webinars
  • 24
  • May
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.

Peggy Berry Peggy Berry | Duration:6 Hours | Price: $545.00 | View Details
  • 28
  • May
  • 2021
  • Friday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Peggy Berry Peggy Berry | Duration:6 Hours | Price: $545.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Peggy Berry

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Peggy Berry

6-Hour Virtual Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Peggy Berry

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Peggy Berry

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Peggy Berry

6-Hour Virtual Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Peggy Berry

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details