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[h2]Course Overview[/h2]
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 three 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.
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[h3]Benefits of Attendance[/h3]
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- 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
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[h3]Now available! Download the current course agenda for PERI’s interactive virtual Clinical Trials in the Pharmaceutical Industry training course.[/h3]
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- 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
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[tab title=”Key Topics”]
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- 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
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[tab title=”Who Should Attend”]
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- Clinical Trial Associates and Managers
- Project Managers
- Clinical Research Associates
- Study Managers and Medical Monitors
- Regulatory Affairs Professionals
- Pharmaceutical Pharmacists
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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 for Pharmacy Education:
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 0708-0000-21-011-L04-P. 1.375 continuing education units (CEUs) are available for this program. Initial Release Date: 10/27/2021. This is an application-based CPE Activity.
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ACCME Statement for Medical Education:
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 13.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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[h2]PERI Course Faculty[/h2]
[h3]Course Director: Allan J. Weinstein, MD[/h3]
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. He currently is a principal in a drug delivery company, which is developing a novel patented technology, provides consulting services to the pharmaceutical industry, and teaches at Northwestern University. 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. Before joining Eli Lilly, Dr. Weinstein spent two years on the faculty at the University of Pennsylvania School of Medicine and eight years on the staff of the Department of Infectious Diseases at the Cleveland Clinic Foundation. 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, including regular interaction with clinical investigators in Canada, the EU, Eastern Europe, Japan, China, Australia, Latin America, and a number of southeast Asian countries.
[h3]Course Faculty: Michael G. Wilson[/h3]
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.
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[h2]Commercial Support[/h2]
No monetary or in-kind financial support (faculty’s time) has been provided a commercial interest for this program.
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[h3]Event Details[/h3]
Date: October 27 – 29, 2021
Time: 11am – 5pm EST (daily)
Location: Virtual Training
Course Rate: $1745
Early Rate: $1545
Early Deadline: September 10, 2021
[button_large color=”orange” url=”/event-registration/?ee=261″] REGISTER NOW [/button_large]
Please have your credit card ready in order to complete registration.
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[h3]Request a Proposal[/h3]
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.
[button_medium color=”orange” url=”/corporate-education/request-a-proposal/”] Request Proposal[/button_medium]
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[h4]Course Information[/h4]
Lauren Kirk
Course Manager
571-490-8409
[button_small color=”slate” url=”mailto:lkirk@peri.org”]Email Question[/button_small]
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[h4]Our Students[/h4]
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[dropcap1]1[/dropcap1] “For me it was a great overall view of all three stages of conducting and designing clinical trials.”
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[dropcap2]2[/dropcap2] “The Clinical Trial Design activities were very useful in understanding the development aspect [of clinical trials].”
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