Course "Clinical Drug Development and Approval Process" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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. 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. The stages of development (Phases 1 - 4) along with formal meetings with the FDA along with important regulatory submissions (IND, Phase I, II, III, NDA) will be described and discussed. Importance of regulatory interaction will be described and discussed along with strategies for providing a successful outcome for both parties. While dynamic tension between the regulatory authority and the pharmaceutical company will occur, it can be used to provide the energy for generating a successful outcome. While the company develops the clinical strategy, the FDA often provides changes that improve it. Reviews of real life drugs will be used as examples along with developing the prescribing information. Pharmacokinetic approaches will be described without the need for understanding the math. The use of pharmacokinetic information will be described. 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. Who Will Benefit: This two-day seminar will provide overview and guidance to scientists who want to develop drugs for a pharmaceutical company or a clinical research organization (CRO) at any management level. • Regulatory • Clinical Pharmacology • Clinical • Product development • Regulatory • Consultants Agenda: Day 1 Schedule: 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 2 Schedule: 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. 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. During his time at GSK, he served as secretary of the protocol review committee and chairman of the Bio Task Force that mentored young scientists during the development process. At Searle he made presentations for generic products at state formularies and reviewed potential licensing candidates. Prior to this, he was Assistant Professor at the University Of Pittsburgh School Of Pharmacy where he taught graduate and undergraduate courses in pharmacokinetics. He also served on the Technical Advisory Committee for the Pennsylvania Generic Drug Formulary. Location: San Diego, CA Date: October 8th & 9th, 2015 Time: 9:00 AM to 6:00 PM Venue: Doubletree by Hilton Hotel San Diego Downtown 1646 Front Street, San Diego, California, 92101, USA Price: $1,295.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) Until August 15, Early Bird Price: $1,295.00 From August 16 to October 06, Regular Price: $1,495.00 Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone: 1-800-447-9407 Fax: 302-288-6884 [email protected] http://www.globalcompliancepanel.com Event Registration Link: https://goo.gl/9iZxcq