Course Overview
PERI’s comprehensive three-day oncology course reviews current and emerging drugs, immunotherapies, their application to specific cancer types, how to conduct clinical trials for oncologic therapies, and the drug development process for drug candidates leading to their approval. The US Food & and Drug Administration (FDA) regulatory considerations for Oncology drugs, registration endpoints, and accelerated and breakthrough approval mechanisms are also covered. This course is ideal for individuals transitioning into the oncology field to explore a variety of cancer types, as well as fundamental components of developing therapies for cancer, including nonclinical development, toxicology, dosing, clinical trial design, and regulatory considerations.
Event Details
Date: March 22 – 24, 2023
Location: Virtual Training
Regular Course Rate: $1,745
This course has concluded. Please visit the Professional Development Calendar to register for upcoming PERI programs.
Benefits of Attendance
- Understand cancer and different treatments including emerging immunotherapies
- Learn clinical endpoints needed for review and regulatory approval
- Be able to discuss leading cancer types such as lung, breast, prostate, and others
- Find out about clinical protocol designs and imaging techniques
- Network with colleagues and experts in the oncology arena
Educational Objectives
- Discuss the scope, nature and epidemiology of top human cancers with an emphasis on principles of case management of common malignancies
- Describe specific applications of commonly used cancer treatments
- Evaluate the design and conduct of oncology Phase I, II, and III clinical trials
- Apply FDA requirements for oncology clinical trials and drug development programs to facilitate/expedite drug development
Who Should Attend
- Clinical Team members
- Nonclinical scientists
- Clinical research associates or CRO staff
- Regulatory affairs professionals
- Statisticians, data managers, medical writers
- Pharmaceutical Physicians
- Anyone working in oncologic drug development or professionals moving to this area
Key Topics
- Overview of Oncology Drug Development, Including Dosing Selection and
Clinical Trial Design - Leading Cancer Types (New Cases/Deaths Per Year)
- Emerging Drugs, Vaccines, other Immunotherapies
- Overview of US Regulatory Pathways and Outcomes
- Pediatric Development Initiatives and Regulations for Pediatric Cancer Treatments
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 12.25 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 0708-0000-23-002-L01-P. 1.225 continuing education units (CEUs) are available for this program. Initial Release Date: 03/22/2023. This is a knowledge-based CPE Activity.
Course Faculty
Marijo Bilusic, MD
University of Miami Health System
Asma Dilawari
US Food and Drug Administration
Shruti Gandhy, MD, PhD
US Food and Drug Administration
Florence Houn, MD, MPH, FACP
Consultant, Drug Development & Regulatory Capacity Building
Malini Iyengar, PhD
TEVA Pharmaceuticals
Chul Kim, MD, MPH
Medstar Georgetown University Hospital
Pashna Munshi, MD
Medstar Georgetown University Hospital
Melanie Royce, MD, PhD
US Food and Drug Administration
Marjilla Seddiq, MD
US Food and Drug Administration
Benjamin Weinberg, MD
Medstar Georgetown University Hospital
Simon Williams, PhD
US Food and Drug Administration
Miao Zhao
US Food and Drug Administration
PERI Facilitator
Jo Ann Zoul
Course Manager/Registrar
571-490-8409
jzoul@peri.org
Commercial Support
Information forthcoming.
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.