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.
- 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
- 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
- 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!”
Marina
Malikova, Ph.D., MSci, MA, CCRA., RAC
Click here for complete trainer
biographies
10 weeks for 3 hours each week.
$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.
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.