Peggy J Berry
Peggy J Berry
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).
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Vendor Selection and Management
This webinar will provide step-by-step considerations for finding potential vendors, implementing a robust qualification & selection process, strategies for oversight and management of vendors, and a risk mitigation approach for key vendors. GxPs are required to be followed, not... -
505(b)(2) New Drug Applications (NDA’s) – 3 Hour Virtual Seminar
NDAs submitted under FD&C 505(b)(2) are a those for which the product is not a generic nor a traditional brand. Learn the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity. NDAs... -
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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. You will learn to translate a clinical protocol into optimal package design. A review of the compliance requirements between clinical, commercial... -
Setting Specifications for Drug Substances and Drug Products
This program will teach you to set specifications for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. The webinar will also cover changing specifications during lifecycle management. Learn... -
GMP Inspections Preparation
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. Regulatory agencies conduct product-related GMP inspections when... -
Advertising and Promotional Material Compliance and Review Process
The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures. This webinar will address issues of compliance in the creation of advertising and promotional materials and the... -
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Clinical Project Management
GCPs are required to be followed during conduct of clinical trials; it is the responsibility of the sponsor to ensure that all aspects of the study comply with legal and regulatory requirements to ensure integrity and reliability of the... -
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... -
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New Requirement for Electronic submission of Drug Master Files (DMFs) – What you need to know
In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications. You will also gain an understanding... -
European Filing and Registration Procedures for Drug Approval
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 many rules and regulations enforced... -
Vital GMP Requirements for Records and Reports
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 final product. The 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 required.... -
ICH Q11 – API Manufacturing
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical...
