Course Overview
In this highly interactive course, participants gain an understanding of the overall pharmaceutical development and regulatory processes by forming a “project team” working together to get a product approved with the required label and within the projected timeline and budget. The initial part of the course covers pharmaceutical development strategy, global regulatory considerations, toxicology, pharmacology, non-clinical safety and chemistry, manufacturing, and control (CMC), leading to the development of a simulated IND. Subsequently, clinical development sessions are added, to provide the groundwork for the development of a simulated NDA. Both the IND and NDA are submitted to, reviewed by, and commented on, by the course instructors, serving as “FDA reviewers”.
Event Details
Date: June 3 – 4, 2024
Time: 8:00 am – 5:00 pm (EDT)
Location:
The Panoramic Conference Room
4000 Legato Road, Suite 1100
Fairfax, VA 22033 USA
Regular Course Rate: $1,845
Save up to 30% with group rates!
Please have your credit card ready in order to complete registration.
Benefits of Attendance
- Learn strategies to increase the effectiveness of pharmaceutical R&D
- Experience submitting an IND and NDA via an interactive simulations.
- Gain a broader view of how successful drugs are developed and reviewed
- Network with expert faculty and colleagues
- Share experiences & challenges in the biopharmaceutical development & regulatory review process
Educational Objectives
- Demonstrate the key components of the drug development process
- Identify the requirements for submitting global drug applications (IND/CTA and NDA/BLA/MAA)
- Relate more effectively with the different functional groups within your organization to facilitate your organization’s drug development and regulatory review process
- Describe the importance of effective communication between the sponsor and the FDA and other regulatory agencies
Course Location
This course will be held just outside of Washington, DC at the:
The Panoramic Conference Room
4000 Legato Road, Suite 1100
Fairfax, VA 22033 USA
There are several hotels nearby, including:
Key Topics
- US and Global Regulatory Affairs
- Non-Clinical Research and Development
- Chemistry, Manufacturing and Control
- Clinical Pharmacology/Pharmacokinetics
- Clinical Development Decisions
- IND & NDA Simulation Workshops
Who Should Attend
- Management and Scientific Professionals
- Non-clinical researchers
- Members of clinical research teams
- Pharmaceutical Pharmacists
- Project managers and regulatory affairs personnel
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.
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.
Course Faculty
Noel J. Cusack, PhD
Independent Nonclinical Consultant
Dr. Cusack is an educator and independent non-clinical consultant to the pharmaceutical industry, with 26 years of pharmaceutical experience in the United States. Dr. Cusack has served in leadership roles in the industry, and prior to working in the pharmaceutical industry, Dr. Cusack has extensive experience in academic research in biology and chemistry. He has taught for PERI for 25 years and serves as the chair of the Curriculum Committee.
Course Faculty
Allan J. Weinstein, MD
Clinical Research and Regulatory Affairs Consultant
Dr. Weinstein is a clinical research and regulatory affairs consultant and infectious disease specialist who spent more than 20 years leading clinical research and regulatory affairs at Eli Lilly and Company. Dr. Weinstein received medical training at Columbia University College of Physicians and Surgeons and was clinically trained at Brigham and Women’s Hospital and the Massachusetts General Hospital.
In his role leading Global Clinical Research and Regulatory Affairs for Eli Lilly, Dr. Weinstein established clinical research and regulatory units in more than 25 countries.
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.