Ms. Peggy J.Berry

Area Of Expertise : Pharma & Drugs
20 Years Of Experience

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).

14 results Found
Live Webinar

Orphan 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 ...

  • Basic & Intermediate
  • 90 Mins
  • Oct 09, 2019
Live Webinar

SOPs for Commercialization

This webinar 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 ...

  • Intermediate
  • 90 Mins
  • Oct 23, 2019
Recorded Webinar

Advertising and Promotional material compliance and review process

The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a r ...

  • Basic & Intermediate & Advanced
  • 90 Mins
On-Demand 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 r ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

  • Intermediate
  • 90 Mins
Recorded Webinar

Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies

This training program will provide attendees with a better understanding of the current audit techniques used by FDA and how they have changed over the years. In addition, areas of increased regulatory scrutiny will also be discussed such a ...

  • Basic & Advanced
  • 90 Mins
Recorded Webinar

Stability Protocols during development & commercialization

This webinar will teach you to create stability protocols for drug substance and drug product, including long term stability; accelerated stability & special stability studies (e.g., light or oxygen sensitivity).Stability testing of pharmaceutical ...

  • Basic & Intermediate
  • 90 Mins
Recorded 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
On-Demand 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