Orphan Drug Development History & Overview

Duration 90 Mins
Level Basic & Intermediate
Webinar ID IQW19J1068

  • Orphan drug development
  • FDA Review and Approval
  • Generic Drug
  • Phases of Development
  • History

Overview of the webinar

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 must be conducted.This program will provide history of the drug development, process evolution  and, review the stages of development, including the critical elements of each stage.

Who should attend?

  • Assistant
  • Associate
  • Manager
  • Anyone needing a full overview of the processes outside their functional area
  • Anyone desiring to enter a career in the pharmaceutical industry

Why should you attend?

This program will provide foundational knowledge of orphan drug development, including the history, leading  to today’s standards and requirements; an overview of current regulatory and legal requirements. This basis will serve to advance understanding of your role in the drug development process.

Faculty - Ms.Peggy J.Berry

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).

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