Course Description

The 10-Week Fundamentals of Drug Development Series will provide an introduction to the scientific, ethical, and regulatory aspects of the drug discovery and 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 discovery and 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. Current trends influencing the pharmaceutic field such as targeted therapy approach in precision medicine, decentralization of clinical trials, digitalization, patient centricity, and changing regulatory landscape will be discussed.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. 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 for small and large molecule drugs
• Provide an overview of current trends and changing regulatory landscape
• 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: Drug Discovery for Small and Large Molecules. Drug Development and Pre-Clinical Studies
• Module 3: Strategic Planning and Operations in the Drug Development Process
• Module 4: Regulatory Requirements for Clinical Development of Drugs and Biologics; Good Clinical Practice Regulations and Recent ICH GCP E6 and E8 Revisions and Their Impact of Drug Development
• 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, Risk Signal Detection and Communications in Clinical Trials
• Module 9: Transition From Clinical Research to Clinical Practice, Factors of Success for Post-Market Launch and Adoption of New Therapies
• 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#: 0778-0000-23-042-L99-P. Released: 10/23.

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