Course Overview

In this highly interactive course, participants gain a better understanding of the overall pharmaceutical development and regulatory processes by forming a “company project team” working together to get their product approved with the required label and within projected timeline and budget. The initial portion of the course covers pharmaceutical development strategy, IND/NDA regulations, non-clinical safety and development, chemistry, manufacturing and controls (CMC), clinical pharmacology and development concepts. These sessions provide the groundwork for interactive IND and NDA simulations.

Benefits of Attendance

  • 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
  • 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
  • Biopharmaceutical Development Decision-Making Overview
  • Regulatory Decision-Making Overview
  • Non-Clinical Research and Development
  • Chemistry, Manufacturing and Control
  • Clinical Pharmacology/Pharmacokinetics
  • Clinical Development Decision-Making Overview
  • IND & NDA Simulation Workshops
  • Management and Scientific Professionals
  • Non-clinical researchers
  • Members of clinical research teams
  • Pharmacists
  • Project managers and regulatory affairs personnel

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 0708-0000-17-007-L01-P. 1.425 continuing education units (CEUs) are available for this program. Initial Release Date: 12/04/17. This is an application based CPE Activity.

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.

Course Faculty

Course Co-Director: Allan J. Weinstein, MD

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.

Course Co-Director: Noel J. Cusack, PhD

Dr. Cusack is an 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, with more than 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.

Event Details

New Program Dates!
Date: December 4 – 5, 2017
Location: PERI Training Facility
Fairfax, VA 22031
Course Rate: $1695
Early Bird Rate: $1495
Early Bird Deadline: 10/16/17

REGISTER NOW

Please have your credit card ready in order to complete registration.

Recommended Hotel

Hyatt House Falls Church/Merrifield
8296 Glass Alley
Fairfax, VA 22031
888-591-1234

PERI participants can take advantage of special rates by using the Group Code “G-NDA2” when making reservations.

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.

Request Proposal






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Jo Ann Zoul
Course Manager
571-490-8409
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