clinical drug development san diego ca
DESCRIPTION
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.The outline for the class will include organization of a pharmaceutical company including preclinical, pharmaceutical development, clinical pharmacology, clinical, and regulatory. Several therapeutic areas will be used in examples. The valuable use of teams will be described by membership and responsibilities. Interactions with different drug company teams will be examined along with interaction with FDA teams.TRANSCRIPT
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Global
CompliancePanel Knowledge, a Way Forward…
2-day In-person Seminar:
Clinical Drug Development and Approval Process
San Diego, CA
Robert Kunka
President & Clinical Drug Development and Approval Process Consultant, The Kunka Group, Inc.
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.
Prior to starting his current career as a consultant (The Kunka Group, Inc.), Bob's experience in drug development stems
from 24 years in the pharmaceutical industry at GlaxoSmithKline (GSK), Chugai-Upjohn, and GD Searle.
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.
October 8th & 9th, 2015 9:00 AM to 6:00 PMRobert Kunka
Course "Applied Statistics for Scientists and Engineers" has been pre-approved by RAPS as
eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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DAY TWODAY ONE
Pharmaceutical company structure and function:
Key groups within pharmaceutical R and D
Understanding the structure and dynamics of teams
Stages of drug development
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
AREAS COVERED IN THE SESSION
Regulatory
Consultants
Agenda:
This seminar provides you with an understanding of the process. People often use the term, "Well, it's not rocket science!", to indicate that
something is not complicated. They could also use the term "Well, it's not drug development!" The process of clinical drug development
utilizes pharmacokinetics, medical, statistics, and other clinically relevant principles to turn a chemical compound into a safe and effective
drug. These key areas will be examined and the process that utilizes them will be examined in a way that draws from real examples.
Who Will Benefit
Regulatory
Clinical Pharmacology
Clinical
Product development
Why you should attend
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
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)
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
Drug delivery systems
Immediate and modified-release oral products
Inhalation
Product extensions
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Group participationsPricing List
**Please note the registration will be closed 2 days (48 Hours) prior to
the date of the seminar.
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Learning Objectives
Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
Special price on future seminars by
GlobalCompliancePanel.
Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
Networking with industry's top notch professionals
What you will get
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
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NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
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[email protected] or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
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NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Toll free: +1-800-447-9407
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Price for One Delegate pass Price:
$ 1,495.00