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.

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 should you 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 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

Price: $1,295.00

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