Ms. Peggy J.Berry

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Profile

Peggy J. Berry, MBA, RAC, is the president and CEO of 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).

12 results Found
Live Webinar

Successful FDA Meeting Preparation and Conduct

The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tend to be general and interpreted in multiple ways. This topic will provide pra ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Sep 18, 2018
Recorded Webinar

Drug Development History & Overview

During discovery, thousands of compounds may be potential candidates for development as a medical treatment. After early testing, however, only a small number of compounds will go on to further study.Before achieving approval, a myriad of research ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

FDA internal 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 ...

  • Intermediate
  • 90 Mins
Recorded Webinar

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

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.  Therefore, only small amounts of investigational material are re ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Packaging and Labeling for Commercial and Clinical Products

This program will discuss practical development of packaging design and optimizing the design to fit the intended purpose. Participants will learn how to translate a protocol into optimal package design. A review of the compliance require ...

  • Intermediate
  • 90 Mins
Recorded Webinar

GMP Requirements for Records and Reports - Documenting Your GMP Activities and Understanding the Vital GMP Requirements of a Documentation System

Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the f ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

EU Registration & Applications

Registration and applications within the European Union can follow various procedures depending on the type of product and the objectives of the sponsor. The pharmaceutical industry is one of the highly regulated industries, with ma ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Preparation for GMP Inspections by Regulatory Agencies

This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.  

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

Complaint Handling

This webinar will provide approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. The information obtained will enable preparation of effective internal systems for receiving, investiga ...

  • Intermediate
  • 90 Mins
Recorded Webinar

SOP Development and Implementation for the Regulated Industry

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization and how to ensure effective communication and training of pro ...

  • Intermediate
  • 90 Mins