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GCPseminar on Clinical Drug Development and Approval Process | Phases Of Clinical Research | Food And Drug Administration
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HOUSE HEARING, 113TH CONGRESS - SECURING OUR NATION'S PRESCRIPTION DRUG SUPPLY CHAIN
x3 White Paper 4
February 5th & 6th, 2015 | San Diego, CA
March 5th & 6th, 2015 | Baltimore, MD
Course "Clinical Drug Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a
participant's RAC recertication upon full completion.
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory &
compliance trainings. These trainings are simple while being relevant and cost-effective while being
convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of
user-friendly mediums such as webinars, seminars, conferences and tailored, individualized
consulting. These help organizations and professionals implement compliance programs that meet
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the regulators or experts on regulation on the one hand, with the community that needs to learn or be
aware of those regulations, on the other.
Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial
Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J,
Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality
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have gained from more than 500 training courses we have conducted till now
2-dayIn-personSeminar2014
Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efcacy and safety of a drug product resulting in regulatory approval. The course will focus on the
clinical aspect. The primary goal of the course will provide students with the basic principles and process for
taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical
principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in
the literature, and approvals from the Food and Drug Administration (FDA) website.
Lecture 1: Pharmaceutical company structure
Key groups within pharmaceutical R and D
Understanding the structure and dynamics of
Lecture 2: FDA structure and function
Lecture 1: Developing a clinical plan
Review relevant package inserts to identify
Develop study designs to address questions
Strengths and weaknesses of using a clinical
Role of pharmacokinetics in drug development
Overall FDA organization with focus on Center
Dynamics of interactions with regulatory
Lecture 2: Pediatric drug development
Key FDA and Europe, Middle East, and Africa
(EMEA) initiatives
Stages of clinical development: Phases 0 - 4
Utilization of adult data
Key regulatory documents: Investigational New
Drug application (IND),New Drug Application (
NDA), Supplemental NDA (sNDA), and
abbreviated NDA (aNDA)
Milestone meetings with FDA
Lecture 3: Stages of clinical development
Utilization of pharmacokinetic and
Strategies for overcoming inherent limitations
of working in children
Lecture 3: Drug delivery systems
Phase 0 - rst time in man
Immediate and modied-release oral products
Phase I - pharmacokinetic, pharmacodynamic,
Phase IIa and IIb - efcacy and safety
Phase III - pivotal efcacy and safety
Phase IV - post-approval
Design questions: healthy subjects vs. patients,
objective vs. subjective endpoints, single vs.
multiple dose, blinded vs. unblended
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