Academy of Physicians
in Clinical Research

Academy of Physicians
in Clinical Research




APCR and PERI Collaboration

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The Pharmaceutical Education and Research Institute, Inc. (PERI) is an independent not-for-profit 501(c)(3) organization dedicated to providing scientific and technical continuing education. All activities are open to anyone in the pharmaceutical, biotechnology, and medical device industry as well as in related organizations including academic institutions and governmental agencies [i.e., the Food and Drug Administration (FDA) and the National Institutes of Health (NIH)].

PERI’s sole activity is to provide quality education and training to the pharmaceutical, biotechnology, and medical product industry. PERI currently is accredited by the Accreditation Council for Continuing Medical Education (ACCME) and the Accreditation Council for Pharmacy Education (ACPE).

PERI and APCR are working together to offer APCR members special discounts on PERI educational offerings. APCR members can save over $300, or the entire value of APCR membership, by taking a few PERI courses. View the course offerings below and take advantage of your APCR membership today.

Members, make sure you are logged in to access a special link for the APCR discount.

Catalog of PERI Courses

Open Courses – Online Education

Basic Pharmacology Blended Online Program
Tuesdays, March 28 – April 5, 2017
This blended course provides an intensive overview of pharmacology, including pharmacokinetics and pharmacodynamics, knowledge of which is critical for both pharmaceutical discovery and development.

Open Courses – Face-to-face Education

Business Group PERI Courses

Project Management in the Research-Based Pharmaceutical Industry
March 30 – 31, 2017 I Fairfax, VA
This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today’s global climate.

Regulation of Marketing and Promotion of Biopharmaceutical
April 3 – 4, 2017 I Fairfax, VA
This course presents industry and FDA experts on current issues regarding FDA regulation of promotional activities such as direct-to-consumer advertising, pharmacoeconomics, scientific exhibits, off-label communications as well as trends in FDA enforcement.

Biologics and Biosimilars: An Integrated Overview of Product Development
April 27 - 28, 2017 I Fairfax, VA
Gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics and biosimilars.

Basic Drug Development: Overview of Biopharmaceutical Research & Development
May 18 – 19, 2017 I Fairfax, VA
This course provides an overview of the pharmaceutical development process, from drug discovery, nonclinical and clinical development, and manufacturing, culminating in product launch and marketing.

Ethical Issues in the Prescription Drug Industry
July 17, 2017 I Fairfax, VA
This interactive course reviews theory, current regulations and pivotal events that led to major reforms. It focuses on ethical considerations that bear on preclinical and clinical research, pricing, promotion, and corporate social responsibility.

Distance Education Courses

Applied Good Clinical Practices (GCP)

This course provides students with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide.

Course Access: Four months from date of registration

Decision Points in Drug Development

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.

Course Access: Two months from date of registration

Good Clinical Practices for the Clinical Research Team Series of 3 Courses

These courses provide a review of the clinical trial process. This series is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor.

This series 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. Students can register for the entire series as a whole, or participate in only the modules that meet their professional education needs.

  • Course #1
    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.

    Course Access: Two months from date of registration

  • Course #2
    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

    Course Access: Two months from date of registration

  • Course #3
    Ensuring Subject Protection & 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.

    Course Access: Two months from date of registration

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.

Course Access: Four months from date of registration

Statistical Concepts Used in Clinical Trials

This course reviews statistical terminology, provide an understanding of statistics, and explain trial design from a clinician’s viewpoint. Most importantly, the course illustrates how statistical tests are chosen and interpreted. The course emphasizes the importance of an ongoing collaboration with a statistician, which creates synergy, enhances creativity, and improves trial design, execution, and analysis

Course Access: Four months from date of registration

Archived Webinars

APCR members have two options for registering for PERI’s on-demand archive webinars

  • Members can view the webinars on-demand for one week at no charge – FREE! For free access, APCR members must register by phone with PERI registrar at 571-490-8409.
  • For extended viewing, members can register online for 30-days unlimited access for only $49 per webinar.
Treating Cancer Webinar Series: A Whole New Ball Game

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.

  • Session #1
    Pre-game 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Introduction to Budgets and Forecasting – The “Keep it Simple” Approach

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.

Writing US Prescribing Information: Top Challenges

This high-level overview reviews elements that people find most challenging when interpreting labeling regulations and developing package inserts, and provides useful tips to equip your team with the knowledge to take the pain out of writing package inserts.

Safety Labeling: Typical Problems and Their Solutions

This webinar covers global safety principles, such as what to include in local and core labeling as an adverse reaction and how to deal with event cascades.

Unwanted Immunogenicity of Biological Drugs

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.

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

This two-hour webinar identifies and explains major considerations in the development process leading to a successful outcome of approval in oncology-hematology.

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.

  • Session #1
    Project Plans: Roadmaps to Project Success

    This webinar discusses determining “how to” plan, the identification of deliverables and the activities needed to complete deliverables. A special focus will be on best practices within the biopharmaceutical industry.

  • Session #2
    Project Teams: Vehicles Along the Road to Project Success

    This webinar discusses how teams are developed and managed, what obstacles a team can encounter during a project, and some tips for addressing these challenges.

  • Session #3
    Project Communication: Mission Control

    This webinar discusses communication channels and how open and proactive communication can go a long way to ameliorating common problems.

 

Publication Date: 
Thursday, August 11, 2016 - 11:30am
Category: