Orphan Drug Development History & Overview

Instructor: Peggy Berry
Product ID: 706069
Training Level: Basic to Intermediate
  • 9
  • August 2019
    Friday
  • 10:00 AM PDT | 01:00 PM EDT
    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.

Live Online Training
August 09, Friday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$429.00

Live + Training CD/USB

$529.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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