6-Hour Virtual Seminar on Introductory Pharmacology for Non-Clinical Professionals

This course is designed to introduce basic pharmacology concepts which are utilized in drug development and clinical research to non-clinical professionals. Topics will include the basic principles of pharmacology and overview of several major classes of therapeutic agents, with attention to their mechanisms of action. Issues of current and future directions in pharmacology will be addressed, including the sources of information about pharmacologic agents, the ethics of human experimentation, the drug development process, and new biotechnological approaches to drug design. FDB3482

Learning Objectives:

  • Become familiar with the concepts of pharmacokinetics and pharmacodynamics
  • Develop knowledge regarding several major classes of therapeutic agents and understand their mechanisms of action
  • Gain an in depth understanding about pre-clinical research and steps necessary for transition to clinical phases of the drug development process
  • Become familiar with the concept of molecular targeted therapeutics
  • Review of Investigator’s Brochure (IB) contents and the Investigational New Drug Application (IND)
  • Critique and analyze information obtained from scientific literature and demonstrate an understanding of the pharmacology parameters

Who Should Attend:

  • Clinical or Project Team Leaders who will be managing projects
  • New Clinical, Regulatory, and Department Staff who will design clinical trial programs
  • Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
  • Grant Administrators
  • Medical Directors
  • Medical Writers
  • Regulatory Affairs Professionals
  • Research and Development Personnel

Marina Malikova

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

Session 1:

  • Introduction: The Heritage of Pharmacology
  • Sources of Information about Drugs
  • Drug-Receptor Interactions
  • Overview of pharmacology parameters utilized in the drug development process (i.e. half-life of the drug, plasma concentration, therapeutic index, area under the curve (AUC), effective concentration EC50, etc.) Regular Copy

Session 2:

  • Principles of Pharmacokinetics (PK studies): Drug Absorption, Distribution, Metabolism and Elimination (ADME parameters overview)
  • Pharmacodynamics (PD studies): Dose-Response Relationships; Time-Concentration Relationships
  • Drug Interactions: CYP enzymes and their role in drug metabolism and drug-drug interactions and side effects
  • Overview of Investigator’s Brochure contents and Investigational New Drug Application (IND)

Session 3:

  • Principles of Endocrine Pharmacology
  • Pharmacology of the Autonomic and Peripheral Nervous System
  • Central Nervous System Pharmacology
  • Pharmacology of Pain and Inflammation

Session 4:

  • Principles of Cardiovascular Pharmacology
  • Principles of Chemotherapy
  • Molecular targeted therapeutics for cancer treatment

membership

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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