2015 - Clinical Drug Development and Approval Process - 2-day In-person Seminar

Overview:
Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy 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.
Agenda:
Day One
Lecture 1: Pharmaceutical company structure and function:
Key groups within pharmaceutical R and D
Understanding? the structure and dynamics of teams
Stages of drug development
Lecture 2: FDA structure and function
Overall FDA organization with focus on Center for Drug Evaluation and Research (CDER)
Dynamics of interactions with regulatory agencies
Stages of clinical development: Phases 0 - 4
Key regulatory documents: Investigational New Drug application (IND),New Drug Application ( NDA), Supplemental NDA (sNDA), and abbreviated NDA (aNDA)
Milestone meetings with FDA
Role of advisory committee
Lecture 3: Stages of clinical development
Phase 0 - first time in man
Phase I - pharmacokinetic, pharmacodynamic, safety
Phase IIa and IIb - efficacy and safety
Phase III - pivotal efficacy and safety
Phase IV - post-approval
Design questions: healthy subjects vs. patients, objective vs. subjective endpoints, single vs. multiple dose, blinded vs. unblended
Regulated product submission (RPS)
Day Two:
Lecture 1: Developing a clinical plan
Review relevant package inserts to identify key questions
Develop study designs to address questions
Strengths and weaknesses of using a clinical research organization
Role of pharmacokinetics in drug development
Lecture 2: Pediatric drug development
Key FDA and Europe, Middle East, and Africa (EMEA) initiatives
Utilization of adult data
Bridging studies
Utilization of pharmacokinetic and pharmacodynamics data
Strategies for overcoming inherent limitations of working in children
Lecture 3: Drug delivery systems
Immediate and modified-release oral products
Inhalation
Product extensions
Speaker:
Robert L. Kunka, Ph.D., is an accomplished and respected scientist who contributed to the development of 28 pharmaceutical products in eight therapeutic areas.
His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams,
and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals.
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