Course Overview
This intermediate course explores the three key phases of clinical development of pharmaceuticals and addresses the skills needed to effectively and safely conduct global clinical trials. Presentations and workshops address the functions and critical decisions made through the clinical development process, from First in Human (FIH) to submission of a New Drug Application (NDA) or Biologics License Application (BLA). In addition to exploring Phases I-III, this course discusses regulatory guidelines, pharmacovigilance, statistical concepts, good clinical practices (GCP), and key roles and responsibilities. Over the course of two days, PERI expert faculty presents key factors to consider in the daily operations aspects of clinical trial conduct, organizational tips, resource planning ideas, financial implications, timeline concerns, regulatory implications, and cross-function communication.
Event Details
Date: December 12 – 13, 2022
Course Location:
Archer Hotel Falls Church
8296 Glass Alley
Fairfax, VA 22031
Course Rate: $1,845
Please have your credit card ready in order to complete registration.
Benefits of Attendance
- Learn the key roles and their responsibilities in clinical trials
- Gain hands-on experience through course workshops
- Identify considerations for setting up and managing global studies
- Learn current trends in clinical development
- Interact and network with faculty and peers involved in clinical trials
Educational Objectives
- Differentiate clinical study designs and determine the appropriate design for each phase of clinical development
- Identify the responsibilities of main personnel in clinical trials
- Utilize Good Clinical Practices when developing clinical programs
- Analyze the key decision points in each phase of development
- Describe regulations for conducting global clinical trials
Course Location
Discounted room rates are available for PERI course participants at the course hotel:
Archer Hotel Falls Church
8296 Glass Alley
Fairfax, VA 22031
571-327-2277
PERI participants can take advantage of a special rate of $199/night + tax.
Reserve through the group block website through November 21, 2022, or book with the Archer Hotel by phone at 855-240-8252.
Key Topics
- Regulatory Considerations: US, EU, Japan
- Designing and Developing Phases I-III
- Clinical Study Reports
- Protocol Writing
- Adaptive Study Design
- Clinical Statistics
- Pharmacovigilance
- Good Clinical Practices
Who Should Attend
- Clinical Trial Associates and Managers
- Project Managers
- Clinical Research Associates
- Study Managers and Medical Monitors
- Regulatory Affairs Professionals
- Pharmaceutical Pharmacists
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 13.5 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 0708-0000-22-012-L04-P. 1.35 continuing education units (CEUs) are available for this program. Initial Release Date: 12/12/2022. This is an application-based CPE Activity.
Course Director
Allan J. Weinstein, MD
Independent 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.
Course Faculty
Michael G. Wilson
Clinical Statistician
Michael G. Wilson has been a practicing statistician for 30 years. In addition, he has been a part-time faculty and adjunct faculty member for the past 12 years teaching statistics at the university, advanced graduate and medical school levels. He began working with PERI in 1992. Michael has co-authored over 50 peer-reviewed research journal articles. Currently, he is an independent biostatistician and co-investigator of NIH and VA studies.
PERI Facilitator
Lauren Kirk
Course Manager
571-490-8409
lkirk@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.