Course Overview
PERI’s fundamental education 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.
In addition to face-to-face training, the Decision Points in Pharmaceutical Development online component introduces the phases of development and the key concepts explored during the live course. This self-study program is included free with your paid registration.
Event Details
Date: May 17 – 19, 2023
Time: 10am – 4pm EDT // 7am – 1pm PDT (daily)
Location: Virtual Training
This course has concluded. Please visit the Professional Development Calendar to register for upcoming PERI programs.
Next Basic Drug Development courses:
August 7-8, 2023 – Boston, MA
November 15-17, 2023 – Virtual Classroom
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
Educational Objectives
- State the basic steps in the drug development process
- Explain the difference between research and development
- Analyze the key decision points in the drug development process
- Evaluate the implications of label based drug development
- Discuss the role of interaction with FDA and other regulatory agencies
Who Should Attend
- 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
Key Topics
- 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
Course Agenda
Now Available! Download the current version of the three-day virtual course agenda.
Continuing Education Credits
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.
Continuing Medical Education (CME)
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 13.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education (CPE)
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 0708-0000-23-004-L01-P. 1.325 continuing education units (CEUs) are available for this program. Initial Release Date: 05/17/2023. This is an application-based CPE Activity.
Course Directors
Noel J. Cusack, PhD
Independent Nonclinical Consultant
Carolyn Finkle, MSc
Senior VP and Head of Regulatory Affairs, Precigen
Course Faculty
Amy Ellis, PhD
US Food and Drug Administration
Asif Mahmood, MD, MPH, MBA
Vice President, Global Safety and Pharmacovigilance
Kamal Tiwari, PhD
US Food and Drug Administration
Allan J. Weinstein, MD
Clinical Research and Regulatory Affairs Consultant
PERI Facilitator
Jo Ann Zoul
Course Manager/Registrar
571-490-8409
jzoul@peri.org
Commercial Support
No monetary or in-kind financial support (faculty’s time) has been provided for this program.
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.