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[h2]Course Overview[/h2]
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.
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[h3]Benefits of Attendance[/h3]
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- 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
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[h3]Download the final agenda for PERI’s upcoming Basic Drug Development course.[/h3]
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- State the basic steps in the drug development process
- Explain the difference between research and development
- Discuss the key decision points in the drug development process
- Explain the implications of label based drug development
- Discuss the role of interaction with FDA and other regulatory agencies
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[tab title=”Key Topics”]
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- Label-Driven Drug Development
- Sources of New Drugs
- Pharmacokinetics & Pharmacodynamics
- Safety & Toxicology
- Regulatory Landscape: US, EU, Japan
- Chemistry, Manufacturing, and Control
- Clinical Development: Phases and Protocols
- Pharmacoeconomics
- Pharmacovigilance
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[tab title=”Who Should Attend”]
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- Professionals new to drug development
- Scientific and non-scientific staff members at all levels
- Members of clinical research teams
- Pharmaceutical Pharmacists
- Medical writers and communication specialists
- Project managers and regulatory affairs personnel
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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:
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 0708-0000-19-004-L01-P. 1.3 continuing education units (CEUs) are available for this program. Initial Release Date: 05/16/19. This is an application-based CPE Activity.
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ACCME Statement:
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 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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[h3]PERI Faculty List[/h3]
Noel Cusack, PhD
Independent Consultant, Nonclinical Development
M. Scott Harris, MD
Principal, Middleburg Consultants
Allan J. Weinstein, MD
Clinical Research and Regulatory Affairs Consultant
Amy Ellis, PhD
Pharmacologist, Division of Anti-Infective Products
US Food and Drug Administration
Kamal N. Tiwari, PhD
Quality Assessment Lead (Acting), Division of Process Assessment III
US Food and Drug Administration
[h3]Commercial Support[/h3]
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: May 16 – 17, 2019
Location: Courtyard by Marriott Dunn Loring/Fairfax
Course Rate: $1,695
This course has concluded. Registration is open for the final 2019 session:
November 14 – 15, Fairfax, VA
Course Hotel
Courtyard by Marriott Dunn Loring/Fairfax
2722 Gallows Road
Vienna, VA 22180
703-573-9555
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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]
[h4]Course Information[/h4]
Jo Ann Zoul
571-490-8409
[button_small color=”slate” url=”mailto:jzoul@peri.org”]Email Question[/button_small]
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[h4]Our Students[/h4]
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[dropcap1]1[/dropcap1] “The group activities were very useful and interesting. Great way to stimulate thinking and discussion.”
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[dropcap2]2[/dropcap2] “The course provided a nice framework from which to make more informed and more timely decisions throughout the pharmaceutical process from my perspective as a project manager.”
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