[three_fourth]
[image src=”/wp-content/uploads/2019/03/nda-simulation-workshop-small-group-2019.png” width=”620″ align=”left”]
[h2]Course Overview[/h2]
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”.
[space height=”10″]
[h3]Benefits of Attendance[/h3]
[icon_list type=”triangle”]
- 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
[/icon_list]
[tabs]
[tab title=”Educational Objectives”]
[icon_list type=”triangle”]
- 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
[/icon_list]
[/tab]
[tab title=”Key Topics”]
[icon_list type=”triangle”]
- US and Global Regulatory Affairs
- Non-Clinical Research and Development
- Chemistry, Manufacturing and Control
- Clinical Pharmacology/Pharmacokinetics
- Clinical Development Decisions
- IND & NDA Simulation Workshops
[/icon_list]
[/tab]
[tab title=”Who Should Attend”]
[icon_list type=”triangle”]
- Management and Scientific Professionals
- Non-clinical researchers
- Members of clinical research teams
- Pharmaceutical Pharmacists
- Project managers and regulatory affairs personnel
[/icon_list]
[/tab]
[tab title=”Continuing Education”]
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 0708-0000-19-010-L01-P. 1.35 continuing education units (CEUs) are available for this program. Initial Release Date: 12/02/19. This is an application-based CPE Activity.
[clear]
[clear]
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 13.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
[clear]
[clear]
[/tab]
[/tabs]
[clear]
[space height=”20″]
[h2]Course Faculty[/h2]
[h3]Course Co-Director: Allan J. Weinstein, MD [/h3]
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.
[space height=”10″]
[h3]Course Co-Director: Noel J. Cusack, PhD [/h3]
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.
[h3]Commercial Support[/h3]
No monetary or in-kind financial support (faculty’s time) has been provided a commercial interest for this program.
[/three_fourth]
[one_fourth_last]
[h3]Event Details[/h3]
Date: December 2-3, 2019
Location: PERI Training Facility
Fairfax, VA 22031
Course Rate: $1695
Early Bird Rate: $1495
Early Bird Deadline: 10/25/19
This course has concluded.
Discover the upcoming schedule of courses on PERI’s Professional Development Calendar.
[space height=”20″]
[h3]Recommended Hotel[/h3]
Courtyard by Marriott
Dunn Loring/Fairfax
2722 Gallows Road
Vienna, VA 22180
703-573-9555
[space height=”20″]
[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]
[space height=”5″]
[h4]Course Information[/h4]
Jo Ann Zoul
Course Manager
571-490-8409
[button_small color=”slate” url=”mailto:jzoul@peri.org”]Email Question[/button_small]
[space height=”1″]
[/one_fourth_last]