The 10-Week Fundamentals of Drug Development Series will provide an introduction to the scientific, ethical, and regulatory aspects of the drug development process throughout the product life cycle and the issues that arise at each phase of new biomedical product development will be explored. Topics will include basic principles and current methodologies used in the drug development field, conduct of clinical trials including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, assignment of study treatments, and endpoints, randomization procedures, adverse event reporting, and protocol compliance monitoring.

The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

Discuss the FDA’s role in drug development
Explain the logistics of the drug development process
Provide an overview of regulations and guidance documents for drugs and biologics submissions
Discuss content and requirements for Investigational New Drug (IND) applications
Review fundamentals of clinical trial structure and design, including Phase I, Phase II, and Phase III clinical studies
Identify scientific and practical issues associated with the planning of a clinical research study
Describe the overall structure of a protocol and regulatory requirements

Course Outline

Module 1: Overview of the Drug Development Process for FDA Regulated Studies
Module 2: Good Clinical Practice (GCPs) Regulations
Module 3: Strategic Planning and Operations in the Drug Development Process
Module 4: Clinical Trial Regulatory Requirements for Drugs and Biologics
Module 5: Regulatory Requirements to Plan, Initiate and Execute a Clinical Trial
Module 6: Developing Clinical Trials/Fundamental Principles of Prospective Design
Module 7: Investigational New Drug Application
Module 8: Safety Monitoring for Clinical Trials
Module 9: Transition From Clinical Research to Clinical Practice
Module 10: Assurance of Compliance and Quality in Clinical Research

Who Should Attend

Clinical, Regulatory, and Department Staff
Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers
Grant Administrators
Medical Directors
Medical Writers
Regulatory Affairs Professionals

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Marina Malikova, Ph.D., MSci, MA, CCRA., RAC

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-20-103-L04-P. Released: 8/20.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.