Peggy J. Berry
President & CEO, Synergy Consulting LLC
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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Recorded Webinar
Quality Control of Raw Materials (APIs and Excipients)
A number of observations on FDA over the past several years reveal that pharmaceutical firms have not been performing adequate testing for incoming APIs, components and raw materials. The regulatory requirements are defined in the GMPs. Because of recognized problems in the incoming material supply chains, the agency is placing more emphasis on material quality. If you make such observations as your base, it appears that some organizations have chosen to ignore/misinterpret the regulatory expectations.
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6-Hour Virtual Seminar on Electronic Common Technical Document (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. Reformatting for multiple submissions is substantially limited. Even though the eCTD has increased efficiency for reviewers and improved submission times, the transition to electronic has also made things more complex. Companies are slowly uncovering several burdens as they transition to the electronic common technical document (eCTD) format.
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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 risk assessment, strategies for mitigating risks and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review processes and procedures to facilitate high compliance standards.
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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 by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. This webinar will review each type of application, when it is required and when it is recommended, along with pros and cons of each type.
Recorded Session Get life time access for one participant with download option!

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
This course will introduce you with a current thinking of the Food and Drug Administration (FDA or Agency) on the topic and provide you with useful specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
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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 of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.
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Implementation of the generic drug labeling rules 2017
FDA is due to release a major Generic Drug Labeling Rule in April 2017. Attend this training to review current generic drug labeling rules and requirements and how they will change with the new rule. Understand the obligations and responsibilities for complying with the new rule as well as how to make submissions to change the product labeling.
Recorded Session Get life time access for one participant with download option!

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 by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. This webinar will review each type of application, when it is required and when it is recommended, along with pros and cons of each type.
Recorded Session Get life time access for one participant with download option!

Preparing Compliant eCTD Submissions: Are you prepared for the upcoming FDA mandate on e-submissions
Beginning in May 2017, the eCTD (CTD - Common Technical Document) will be required in the US for all marketing applications. This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

Packaging and Labeling for Commercial and Clinical Products
This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
Recorded Session Get life time access for one participant with download option!

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