Orphan Drug Development History & Overview

Speaker

Instructor: Peggy Berry
Product ID: 706069
Training Level: Basic to Intermediate

Location
  • Duration: 90 Min
This program will provide foundational knowledge of orphan drug development, including the history, leading to today’s standards and requirements. You will get an overview of current regulatory and legal requirements. This basis will serve to advance understanding of your role in the drug development process.
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Why Should You Attend:

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.

Areas Covered in the Webinar:

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

Who Will Benefit:

Pharma industry

  • 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
Instructor Profile:
Peggy Berry

Peggy Berry
Founder, 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, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

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