Global

CompliancePanel

Knowledge, a Way Forward

2-day In-person Seminar:

Clinical Drug Development and Approval Process

Robert Kunka

San Diego, CA

October 8th & 9th, 2015

9:00 AM to 6:00 PM

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 recertication upon full completion.

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
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.

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Knowledge, a Way Forward

Agenda:
DAY ONE

DAY TWO

Pharmaceutical company structure and function:

Developing a clinical plan

Review relevant package inserts to identify key

Key groups within pharmaceutical R and D

questions

Understanding the structure and dynamics of teams

Develop study designs to address questions

Stages of drug development

Strengths and weaknesses of using a clinical

research organization

FDA structure and function

Role of pharmacokinetics in drug development

Overall FDA organization with focus on Center for

Drug Evaluation and Research (CDER)

Dynamics of interactions with regulatory agencies

Pediatric drug development

Key FDA and Europe, Middle East, and Africa

Stages of clinical development: Phases 0 - 4

(EMEA) initiatives

Key regulatory documents: Investigational New

Utilization of adult data

Drug application (IND),New Drug Application (

NDA), Supplemental NDA (sNDA), and abbreviated
NDA (aNDA)

Bridging studies
Utilization of pharmacokinetic and

pharmacodynamics data

Milestone meetings with FDA

Strategies for overcoming inherent limitations of

Role of advisory committee

working in children

Stages of clinical development

Drug delivery systems

Phase 0 - rst time in man

Immediate and modied-release oral products

Phase I - pharmacokinetic, pharmacodynamic,

safety

Inhalation

Phase IIa and IIb - efcacy and safety

Product extensions

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
Regulated product submission (RPS)

Who Will Benet

Regulatory

Regulatory

Clinical Pharmacology

Consultants

Clinical
Product development

AREAS COVERED IN THE SESSION

Why you should attend
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.

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Pricing List

Knowledge, a Way Forward

Group participations

Price for One Delegate pass Price:

2 Attendees to get offer

10%

$ 1,495.00

3 to 6 Attendees to get offer

20%

Register Now

7 to 10 Attendees to get offer

25%

10+ Attendees to get offer

30%

**Please note the registration will be closed 2 days (48 Hours) prior to
the date of the seminar.

What you will get

Learning Objectives
Participation certificates

Payment Option
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Visa/Master/American Express card click on the
register now link

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Look forward to meeting you at the seminar

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GlobalCompliancePanel

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