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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 foundation courses in San Francisco.[/h3]
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- State the basic steps in the drug development process
- Explain the difference between research and development
- Analyze the key decision points in the drug development process
- Evaluate the implications of label based drug development
- Discuss the role of interaction with FDA and other regulatory agencies
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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.
Session 1: January 28-29, 2020
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 0708-0000-20-001-L01-P. 1.425 continuing education units (CEUs) are available for this program. Initial Release Date: 01/28/2020. 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 14.25 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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Session 2: January 30-31, 2020
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 0708-0000-20-002-L01-P. 1.425 continuing education units (CEUs) are available for this program. Initial Release Date: 01/30/2020. 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 14.25 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]Course Faculty[/h2]
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[h3]Course Co-Director: Allan J. Weinstein, MD [/h3]
Clinical Research and Regulatory Affairs Consultant
Dr. Weinstein is an 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.
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[h3]Course Co-Director: Noel J. Cusack, PhD [/h3]
Independent Consultant, Nonclinical Development
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 at Talaris Advisors, LLC, Alseres Pharmaceuticals, Aderis Pharmaceuticals, Whitby Research, Inc., and Nelson Research Center. Prior to working in the pharmaceutical industry, Dr. Cusack has extensive experience in academic research in biology and chemistry for 16 years in the UK at the University of Cambridge and at King’s College London, with nearly 100 publications. Dr. Cusack has a wide variety of teaching experience in the US and abroad both within the university setting and the pharmaceutical industry. He has taught for PERI for 25 years, including establishing the Basic Pharmacology and Pharmacology online programs, and serves as the chair of the Curriculum Committee.
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[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]
Session 1: January 28 – 29, 2020
Session 2: January 30 – 31, 2020
Location: Attune San Francisco
(Formerly Microtek)
655 Montgomery St., Ste. 400
San Francisco, CA 94111
Course Rate: $1795
Registration has closed for these courses. Please visit our Professional Development Calendar to see the schedule of upcoming courses.
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Download PERI’s San Francisco Hotel Guide for details on discounted accommodations for course students.
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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]
Lauren Kirk
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] “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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