Oncology Series Session #1 – Introduction to Oncology

This webinar provides a broad general overview of oncology from the perspective of current drug development. Starting with the biological characteristics of cancer and the genetic factors that are involved in transforming normal cells into cancer cells, we will review traditional and modern classification, staging, grading and treatment of human malignancies, including the use of biomarkers.
Length: 81 min

Price: $175.00


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Oncology Series Session #2 – Cancer is Different: Clinical Trials in Oncology Drug Development

Oncology drugs, like other agents, pass through a development sequence of three major phases. However, clinical development of oncology drugs has many important differences from that of other therapeutic agents. This presentation will highlight and explain the reasons for these differences.
Length: 83 min

Price: $175.00


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Oncology Series Session #3 – Best Laid Plans: Oncology Product Development

This webinar provides an introduction to industrial clinical and product development plans in oncology and establishes benchmarks for the drug development process that can be used to evaluate progress, and provides estimates of net present value of each option.

Length: 76 min

Price: $175.00


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Principles of Clinical Oncology

This webinar is a survey of methods used by the practicing oncologist to manage cancer, including interdisciplinary approaches, the use of histiotype, stage, grade and biomarkers in the assessment of a cancer patient, major treatment modalities and strategies, assessment of response and toxicity, and follow-up and communication practices.
Length: 57 min

Price: $175.00


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Statistical Concepts Used in Clinical Trials

This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system.

Price: $645.00


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Pharmacology Online: The Fundamental Principles

This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system. Inflammation and anti-inflammatory drugs are next presented, and the course concludes with a discussion of agents used in infectious disease and chemotherapy.

Price: $615.00


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Ensuring Subject Protection and Scientific Integrity

This course explains the FDA inspection process, identifies common deficiencies and regulations guiding FDA inspections and identifies the sponsor’s responsibilities in monitoring study sites. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

Price: $160.00


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Good Clinical Practices for the Clinical Research Team: (3 Courses)

These courses provide a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor. This course provides an excellent tool for the training and education of all members of the sponsor and clinical research teams to insure their knowledge and understanding of the clinical research process and GCPs. Included with each course is a downloadable, Student Guide containing the course script and a glossary of terms.

Price: $590.00


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Implementing a Clinical Trial Program

This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials. Key course factors include investigator selection and responsibilities, clinical research protocol, data management and adverse event reporting. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

Price: $320.00


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The Regulatory Context for Conducting Clinical Trials

This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the IRB/ED’s. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

Price: $240.00


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Decision Points in Pharmaceutical Development: Discovery to Market

This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch.

Price: $450.00


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Clinical Monitoring and Site Management: The Fundamentals

The goal of this course is to provide a practical orientation to site management and monitoring of clinical studies. The course provides a comprehensive overview of clinical monitoring in the context of the overall drug development process; FDA and HPB regulations; and ICH guidelines for GCP. The course combines text-based study materials with interactive exercises enabling you to apply what you have learned to on-the-job situations.

Price: $590.00


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Applied Good Clinical Practices (GCP): Online Course

This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH.

Price: $590.00


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Aggressive Non-Hodgkin’s Lymphoma

This webinar explores the current management of and novel treatments for peripheral T-cell lymphomas after reviewing an overview of the disease and current standards of care.

Price: $175.00


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Doing it Right: Medical Ethics in Oncology Drug Development

This webinar provides a review and discussion of various issues in medical ethics that are of particular relevance to clinical trials in oncology.

Price: $175.00


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Avoiding Sudden Death: QTc Studies in Oncology

This webinar reviews the operation of the heart’s conduction system and the normalization methods that correct the raw QT data for heart rate, producing the QTc parameter. For comparison, we will describe congenital prolonged QT syndrome and note its special features.

Price: $175.00


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Oncology Series Session #1 – Introduction to Oncology

This webinar provides a broad general overview of oncology from the perspective of current drug development. Starting with the biological characteristics of cancer and the genetic factors that are involved in transforming normal cells into cancer cells, we will review traditional and modern classification, staging, grading and treatment of human malignancies, including the use of biomarkers.

Price: $175.00


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Oncology Series Session #2 – Cancer is Different: Clinical Trials in Oncology Drug Development

Oncology drugs, like other agents, pass through a development sequence of three major phases. However, clinical development of oncology drugs has many important differences from that of other therapeutic agents. This presentation will highlight and explain the reasons for these differences.

Price: $175.00


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Oncology Series Session #3 – Best Laid Plans: Oncology Product Development

This webinar provides an introduction to industrial clinical and product development plans in oncology and establishes benchmarks for the drug development process that can be used to evaluate progress, and provides estimates of net present value of each option.

Price: $175.00


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Oncology Series Session #3 – Best Laid Plans: Oncology Product Development (Duplicate)

This webinar provides an introduction to industrial clinical and product development plans in oncology and establishes benchmarks for the drug development process that can be used to evaluate progress, and provides estimates of net present value of each option.

Price: $175.00


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Principles of Clinical Oncology

This webinar is a survey of methods used by the practicing oncologist to manage cancer, including interdisciplinary approaches, the use of histiotype, stage, grade and biomarkers in the assessment of a cancer patient, major treatment modalities and strategies, assessment of response and toxicity, and follow-up and communication practices.

Price: $175.00


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Principles of Cancer Pharmacology

This webinar presents key factors in the treatment of cancer with drugs, and discusses the discovery and development process, different classes of cytotoxic and targeted anticancer drugs, cytokines and immune-based therapy, radiosensitizers, radioprotectors and supportive care agents.

Price: $175.00


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Hematologic Malignancies: Why Are They Important?

This webinar is a review of epidemiologic data, clinical presentations, and major advances in treatment over the past decade.

Price: $175.00


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Unwanted Immunogenicity of Biological Drugs

This webinar will define the basic principles and importance of unwanted immunogenicity of biological drug candidates. Discussion will focus on potential causes of immunogenicity, impact on safety and efficacy of anti-drug antibody development.

Price: $175.00


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Proposed Changes to EU Medical Device Directives

The webinar investigates the proposed EU Medical Devices Directives: the ideas behind the original directives, how these have changed over the years, what has worked well and what has worked badly.

Price: $175.00


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Study Recruitment and Working with Investigative Sites

This webinar covers key aspects to consider in developing and executing an effective subject recruitment strategy.

Price: $175.00


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Device Classification and the 510(k) Premarket Notification Process

This presentation is designed to give an overview of the US medical device classification scheme and the 510(k) Premarket Notification process, used for over 90% of medical device marketing clearances.

Price: $175.00


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Drug Development in India

India will be the third major pharmaceutical market by 2020. Indian patients must be studied but in addition they can help towards the US requirement of representative Asian patients in US filing.

Price: $175.00


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Drug Development in China

China is a new emergent market and may overtake Japan in four year’s time, pharmaceutical firms must learn how to utilize Chinese patients in CTD while satisfying China’s regulatory requirements.

Price: $175.00


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Overview of Biopharmaceutical R&D

Those in domestic or international biopharmaceutical companies who are new to drug development or interested in a comprehensive overview of the drug development process will benefit from this webinar.

Price: $175.00


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Basic Pharmacodynamics: Principles and Importance in the Pharmaceutical Industry

This webinar defines the basic principles and importance of pharmacodynamics as it applies to drug development. It will describe the methods utilized in pharmacodynamic analyses including dose-response relationships for drug activity.

Price: $175.00


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Basic Toxicology – Safety Studies To Enable Testing Therapies in Humans

This webinar explains how to detect a product’s activity through nonclinical pharmacology and how to determine a product’s risk profile through nonclinical safety assessment. Choosing a first dose for clinical trials and major issues associated with the current focus on biopharma risk (safety) using real-life examples is explained.

Price: $175.00


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Pulmonary Drug Delivery Series – Session 1: Introduction

This webinar series provides an overview of the development process of pulmonary drug delivery products and will be presented in five weekly sessions.

Price: $175.00


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Pulmonary Drug Delivery Series – Session 2: Devices and Formulations

This webinar series provides an overview of the development process of pulmonary drug delivery products. The second session covers details of nebulizers, pressurized metered dose inhalers (pMDI) and dry powder inhalers (DPI) and their pros and cons.

Price: $175.00


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Still in Harmony: The International Conference on Harmonization (ICH)

In the last eighteen years ICH has reached agreement on many aspects of the regulatory requirements of clinical toxicology and manufacturing requirements. We will cover the major agreements.

Price: $175.00


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Introduction to Budgets and Forecasting – The “Keep It Simple” approach

This webinar provides an introduction to developing study budgets and forecasting study costs.

Price: $175.00


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Basic Pharmacodynamics: Principles and Importance in the Pharmaceutical Industry

This webinar defines the basic principles and importance of pharmacodynamics as it applies to drug development. It will describe the methods utilized in pharmacodynamic analyses including dose-response relationships for drug activity.

Price: $175.00


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Project Management Archived Webinar Series

This three-part webinar series addresses the fundamentals of Project Management as it applies to the research-based biopharmaceutical industry.

Price: $259.00


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Treating Cancer Session #1 – Pregame Ceremonies: Cancer Biology, Oncology and Immunology

This webinar is an overview of oncology from the perspective of the oncologist and the developer of cancer drugs and is intended for newcomers to the field. After a review of the basic biology of cancer, including oncogenes, signal transduction pathways, the cell cycle, angiogenesis and drug resistance mechanisms, the use of histotype, stage, grade and biomarkers in the assessment of a cancer patient is discussed. This session reviews the immune response, including the innate immune response, adaptive immunity, cells and structures of the immune system, the generation of antigen receptors, signaling through immune receptors, vaccines, the humoral (antibody) response, the cellular response, and methods to manipulate the immune response as clinical treatment.

Price: $175.00


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Treating Cancer Session #2 – The Home-Field Advantage: Tumor Immunology

This webinar focuses on the mechanisms by which tumors escape normal immune surveillance. We review the nature of tumor immune surveillance, the “ideal” response of the immune system to cancer, and mechanisms that tumors use to evade surveillance and generate a state of tolerance. New treatments to break this tolerance and allow the immune system to attack the tumor are being developed. We will discuss theoretical approaches, the mechanisms of the new successful agents, selected failures of certain approaches, and ongoing clinical studies in this new area of cancer treatment.

Price: $175.00


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Treating Cancer Session #3 – The Starters: Monoclonal Antibodies

The explosive growth of monoclonal antibody products in the past five years requires understanding of their pharmacology and important clinical results. The first part of this session addresses with mAbs that act through ADCC, through growth-factor processes, as mAb-cytotoxin conjugates and as mAb-radioisotope conjugates. The second part covers mAbs that target tumor microenvironment, counteract tolerance mechanisms, or stimulate cell-mediated antitumor effects.

Price: $175.00


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Treating Cancer Session #4 – The Deep Bench: Cytokines and Vaccines

This webinar covers the three major categories of cytokines from a pharmacologic and clinical application perspective, and discusses important considerations in the clinical development and use of both preventive and therapeutic vaccines in oncology.

Price: $175.00


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Treating Cancer Session #5 – The Bull Pen: Targeted Small Molecules

This webinar surveys small molecules used as drugs that target oncogene-related abnormalities in cancer cells. The content focuses on agents that have recently achieved regulatory approval based on clinical trial successes.

Price: $175.00


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Treating Cancer Session #6 – The New Rule Book: Pharmacodynamics and Pharmacokinetics of Biologicals

Biological therapeutic proteins require special considerations from a pharmacokinetic and pharmacodynamics perspective. Certain characteristics are shared by large polypeptides such as cytokines, but monoclonal antibodies present particular challenges based on immunogenicity, IgG recycling processes and target-mediated drug distribution. Finally, we discuss how the therapeutic effects of mAbs that alter tumor microenvironment can influence the pharmacokinetics of low-molecular-weight cytotoxic agents.

Price: $175.00


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Treating Cancer – Bundle of 6 Webinars

The field of immune-oncology has exploded in the past five years, and has achieved transformational successes in a number of important human malignancies. Professionals in the field, as well as primary caregivers, pharmaceutical researchers, third-party payers, commercial decision-makers, and patient advocates need comprehensive understanding of this area as it relates to their roles.

This series of six webinars covers the area of immune-oncology in the context of pharmacologic and immunologic background, specific agents now approved, and changing practices and outlook for the cancer patient.

Price: $800.00


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Applied Good Clinical Practices (GCP): Online Course – APCR Member Rate

This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH.

Special rate for APCR members: $413.00 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $590.00
APCR Member Rate: $413.00 (save $177.00!)

Price: $413.00


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Decision Points in Pharmaceutical Development: Discovery to Market – APCR Member Rate

This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch.

Special rate for APCR members: $315.00 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $450.00
APCR Member Rate: $315.00 (save $135.00!)

Price: $315.00


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Good Clinical Practices for the Clinical Research Team: 3 Courses – APCR Member Rate

These courses provide a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor. This course provides an excellent tool for the training and education of all members of the sponsor and clinical research teams to insure their knowledge and understanding of the clinical research process and GCPs. Included with each course is a downloadable, Student Guide containing the course script and a glossary of terms.

Special rate for APCR members: $413.00 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $590.00
APCR Member Rate: $413.00 (save $177.00!)

Price: $413.00


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Ensuring Subject Protection and Scientific Integrity – APCR Member Rate

This course explains the FDA inspection process, identifies common deficiencies and regulations guiding FDA inspections and identifies the sponsor’s responsibilities in monitoring study sites. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

Special rate for APCR members: $112.00 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $160.00
APCR Member Rate: $112.00 (save $48.00!)

Price: $112.00


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Implementing a Clinical Trial Program – APCR Member Rate

This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials. Key course factors include investigator selection and responsibilities, clinical research protocol, data management and adverse event reporting. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

Special rate for APCR members: $224.00 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $360.00
APCR Member Rate: $224.00 (save $112.00!)

Price: $224.00


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Pharmacology Online: The Fundamental Principles – APCR Member Rate

This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system. Inflammation and anti-inflammatory drugs are next presented, and the course concludes with a discussion of agents used in infectious disease and chemotherapy.

Special rate for APCR members: $430.50 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $615.00
APCR Member Rate: $430.50 (save $184.50!)

Price: $430.50


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Statistical Concepts Used in Clinical Trials – APCR Member Rate

This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system.

Special rate for APCR members: $451.50 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $645.00
APCR Member Rate: $451.50 (save $193.50!)

Price: $451.50


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The Regulatory Context for Conducting Clinical Trials – APCR Member Rate

This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the IRB/ED’s. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

Special rate for APCR members: $468.00 (30% savings!)
*Verification of membership is required before beginning the course.*

 

Regular Rate: $240.00
APCR Member Rate: $168.00 (save $72.00!)

Price: $168.00


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The Science Behind FDA Drug Approval: Clinical Trial Designs, Endpoints, Verification, and Requirements for Hematology Oncology Drugs

This new interactive two-hour webinar, presented by a retired FDA deputy director, identifies and explains major considerations in the development process leading to a successful outcome of approval in oncology-hematology.

Price: $175.00


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Treating Cancer Session #1 – Pregame Ceremonies: Cancer Biology, Oncology and Immunology – APCR Member 30 Days

This webinar is an overview of oncology from the perspective of the oncologist and the developer of cancer drugs and is intended for newcomers to the field. After a review of the basic biology of cancer, including oncogenes, signal transduction pathways, the cell cycle, angiogenesis and drug resistance mechanisms, the use of histotype, stage, grade and biomarkers in the assessment of a cancer patient is discussed. This session reviews the immune response, including the innate immune response, adaptive immunity, cells and structures of the immune system, the generation of antigen receptors, signaling through immune receptors, vaccines, the humoral (antibody) response, the cellular response, and methods to manipulate the immune response as clinical treatment.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Treating Cancer Session #2 – The Home-Field Advantage: Tumor Immunology – APCR Member 30 Days

This webinar focuses on the mechanisms by which tumors escape normal immune surveillance. We review the nature of tumor immune surveillance, the “ideal” response of the immune system to cancer, and mechanisms that tumors use to evade surveillance and generate a state of tolerance. New treatments to break this tolerance and allow the immune system to attack the tumor are being developed. We will discuss theoretical approaches, the mechanisms of the new successful agents, selected failures of certain approaches, and ongoing clinical studies in this new area of cancer treatment.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Treating Cancer Session #3 – The Starters: Monoclonal Antibodies – APCR Member 30 Days

The explosive growth of monoclonal antibody products in the past five years requires understanding of their pharmacology and important clinical results. The first part of this session addresses with mAbs that act through ADCC, through growth-factor processes, as mAb-cytotoxin conjugates and as mAb-radioisotope conjugates. The second part covers mAbs that target tumor microenvironment, counteract tolerance mechanisms, or stimulate cell-mediated anti-tumor effects.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Treating Cancer Session #4 – The Deep Bench: Cytokines and Vaccines – APCR Member 30 Days

This webinar covers the three major categories of cytokines from a pharmacologic and clinical application perspective, and discusses important considerations in the clinical development and use of both preventive and therapeutic vaccines in oncology.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Treating Cancer Session #5 – The Bull Pen: Targeted Small Molecules – APCR Member 30 Days

This webinar surveys small molecules used as drugs that target oncogene-related abnormalities in cancer cells. The content focuses on agents that have recently achieved regulatory approval based on clinical trial successes.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Treating Cancer Session #6 – The New Rule Book: Pharmacodynamics and Pharmacokinetics of Biologicals – APCR Member 30 Days

Biological therapeutic proteins require special considerations from a pharmacokinetic and pharmacodynamics perspective. Certain characteristics are shared by large polypeptides such as cytokines, but monoclonal antibodies present particular challenges based on immunogenicity, IgG recycling processes and target-mediated drug distribution. Finally, we discuss how the therapeutic effects of mAbs that alter tumor microenvironment can influence the pharmacokinetics of low-molecular-weight cytotoxic agents.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Introduction to Budgets and Forecasting – The “Keep It Simple” Approach – APCR Member 30 Days

This webinar provides an introduction to developing study budgets and forecasting study costs.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Unwanted Immunogenicity of Biological Drugs – APCR Member 30 Days

This webinar defines the basic principles and importance of unwanted immunogenicity of biological drug candidates. Discussion focuses on potential causes of immunogenicity, impact on safety and efficacy of anti-drug antibody development.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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The Science Behind FDA Drug Approval – APCR Member 30 Days

This new interactive two-hour webinar, presented by a retired FDA deputy director, identifies and explains major considerations in the development process leading to a successful outcome of approval in oncology-hematology.

Special 30-day access rate for APCR members: $49.00
*Verification of membership is required before beginning the course.*

Price: $49.00


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Project Management Archived Webinar Series – APCR Member 30 Days

This three-part webinar series addresses the fundamentals of Project Management as it applies to the research-based biopharmaceutical industry.

Special 30-day access rate for APCR members: $99.00
*Verification of membership is required before beginning the course.*

Price: $99.00


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