Course Overview

In a blending of online and live learning, this course provides an overview of the process and issues common to all new chemical entity (NCE) development projects, from the research and development stages through product launch and post-marketing safety. The course focuses on the decisions that need to be made throughout the therapeutic development process and the criteria influencing these decisions. The faculty for this flagship course are selected as experts in their field. The online component is PERI’s Decision Points in Drug Development.

Benefits of Attendance

  • Identify the basic steps in drug development
  • Gain hands-on experience through practical drug development workshops.
  • Understand team responsibilities in pharmaceutical development
  • Learn key aspects and updates in the regulatory process for US, Europe and Japan

Download Tentative Course Agenda

  • Follow the basic steps in the drug development process
  • Distinguish between research and development
  • Recognize the key decision points in the drug development process
  • Explain the implications of label based drug development
  • Value the role of interaction with FDA and other regulatory agencies
  • Non-Clinical Drug Development
  • Decision Points in Drug Development
  • Regulatory Review Process (FDA, EMEA)
  • Portfolio Review
  • Meeting with Regulatory Agencies
  • Drug & Biologic Product Manufacturing
  • Clinical Trial Design
  • Safety in the Drug Development Process
  • Global Considerations in Drug Development
  • Panel Discussion with FDA Representatives: Putting It All Together
  • Professionals new to drug development
  • Scientific and non-scientific staff members at all levels
  • Members of clinical research teams
  • Medical writers and communication specialists
  • Project managers and regulatory affairs personnel

REGISTRATION INFORMATION/CONTINUING EDUCATION CREDIT
Course # 01C

Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator.

ACPE Statement:
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is 0708-0000-13-001-L03-P. 1.4 continuing education units (CEUs) are available for this program. Initial Release Date: 05/09/2013. This is a knowledge based CPE Activity.

ACCME Statement:
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 14 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Event Details

Date: May 9-10, 2013
Location: Arlington, VA
Course Rate: $1795
Early Bird Rate: $1595
Early Bird Deadline: 3/25/2013

Registration has closed for this event.

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Interested in bringing this course to your company? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.

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Course Director

Carolyn D Finkle, MSc
Vice President, Global Regulatory Consulting
Catalent Pharma Solutions

Course Information

Marian Selby
Course Manager
703-276-0178, ext. 192
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Our Students

  • 1 “This provided an overview of the drug development process which enables me to understand the tasks my colleagues undertake.”

  • 2 “Love the workshops! Excellent activities and follow-up discussions. I learned that it is not easy to manage a portfolio because of all the elements you must consider.”