Course Overview

In a blending of online and live learning, this course provides an overview of the pharmaceutical development process, from drug discovery, nonclinical and clinical development, and manufacturing, culminating in product launch and marketing. 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 newly revised Decision Points in Pharmaceutical Development.

Benefits of Attendance

  • Identify the basic steps in pharmaceutical development
  • Gain hands-on experience through practical pharmaceutical development workshops
  • Understand team responsibilities in pharmaceutical development
  • Learn key aspects and updates in the regulatory process for US, Europe and Japan
  • State the basic steps in the drug development process
  • Explain the difference between research and development
  • Discuss the key decision points in the drug development process
  • Explain the implications of label based drug development
  • Discuss 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
  • Pharmacists
  • Medical writers and communication specialists
  • Project managers and regulatory affairs personnel

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. Additional $35 fee applies for students who are applying for continuing education credit.

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 0708-0000-17-006-L01-P. 1.3 continuing education units (CEUs) are available for this program. Initial Release Date: 11/16/17. 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 13 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Course Faculty

Noel J. Cusack, PhD
Course Co-Director
Independent Nonclinical Consultant

Carolyn Finkle, MSc
Course Co-Director
Vice President Regulatory Affairs, Karyopharm Therapeutics

M. Scott Harris, MD
Chief Medical Officer, Lyric Pharmaceuticals

Amy Ellis, PhD
Pharmacologist, Division of Anti-Infective Products
Office of New Drugs
US Food and Drug Administration

Edwin Jao, PhD
Acting Branch Chief, OPF DPA III, Branch VII
Office of Pharmaceutical Quality
US Food and Drug Administration

Nallaperumal Chidambaram, PhD
Acting Branch Chief, OPF DPA III, Branch VIII
Office of Pharmaceutical Quality
US Food and Drug Administration

Event Details

Date: November 16-17, 2017
Location: DoubleTree by Hilton – Crystal City, Arlington, VA

This course has concluded. Please view our course calendar for Spring 2018 course information.

Course Location

DoubleTree by Hilton
Washington, DC – Crystal City

300 Army Navy Drive
Arlington, VA 22202
(703) 416-4100

Request a Proposal

Interested in bringing this course to your group of 10 or more? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.

Request Proposal

Request Proposal

Your Name (required)

Your Title (required)

Your Company (required)

Your Email (required)

Your Phone(required)

Subject of Interest(required)

Additional Information
(# Attendees, Location, Live/Online Learning, etc.)

How did you hear about us?

Course Directors

Carolyn D Finkle, MSc
VP Regulatory Affairs
Karyopharm Therapeutics

Noel J. Cusack, PhD
Independent Nonclinical Consultant

Course Information

Jo Ann Zoul
Email Question

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.”