Full Day Virtual Seminar: Clinical Research GCP training Course
Charles H Pierce
5 hrs
Product Id: 702001
This full day GCP training course will provide comprehensive learning on the Good Clinical Practices of Research involving human subjects. It will cover all key areas including recruiting study subjects, the Informed Consent process, Adverse Event Reporting and preventing protocol deviations.
Clinical Trial auditing - Identifying risks and building a more compliant and successful trial
Peter Calcott
90 Min
Product Id: 701214
This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.
New amendments of Critical parameters in Canadian Clinical trials
Calin Popa
60 Min
Product Id: 701871
Learn about last changes in Canadian ethics regulations, understand how to apply the change in the day-to-day work.
Adaptive Designs for Clinical Trials: How to Enhance Your Study's Chances for Success while Saving Time and Money for Your Company
Teresa Nelson,Melissa Martinson,Manya Harsch
68 Min
Product Id: 701956
This training on adaptive designs for clinical trials will help you indentify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.
Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance
Madhavi Diwanji
60 Min
Product Id: 701868
Discussion on role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (GCP)
Presenting the real GCP handbook: Build solid knowledge of GCP by learning the rules exactly as they appear in the official text
Leonidas Lambrinidis
78 Min
Product Id: 701888
Get a complete understanding of GCP through a comprehensive analysis of GCP official text - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.
Clinical Research Revenue Cycle: Bridging Health Systems and Clinical Research
Mary Veazie
120 Min
Product Id: 706775
Clinical research revenue cycle (CRRC) is an integral part of a clinical research portfolio. It is a complex environment that bridges a health systems revenue cycle with clinical research activities. Health systems involved in clinical research activities struggle with effectively incorporating these two environments. In this course, attendees will learn framework for an effective and compliant CRRC program.
Incorporating Denials Management into Clinical Research Billing
Mary Veazie
120 Min
Product Id: 706795
Data is an organization’s biggest asset. For clinical research billing programs, an organization’s revenue data can be a vital resource to strengthen controls and mitigate risk. This course will focus on leveraging denials data to strengthen the coverage analysis development and an organization’s clinical research billing program. You will learn to utilize the rich data in an organization’s clinical research revenue cycle to strength controls and mitigate risk.
Risk Mitigation Strategies for Clinical Research Finance
Mary Veazie
120 Min
Product Id: 706788
Organizations engaged in clinical research activities are exposed to risk and must develop risk mitigation strategies. This course is designed to provide attendees with strategies to mitigate the risk and develop controls to ensure a compliant clinical research billing program. Attendees will learn various control strategies and leading practice within a clinical research billing program.
Overview of the Financial Aspects of Clinical Research
Mary Veazie
120 Min
Product Id: 706778
The financial processes supporting a clinical research study is arguably the most important aspect of the study’s life cycle. Without an understanding of clinical research finance, organizations and individuals can unknowingly violate federal regulations and subject the organization participating in clinical research activities to fines, penalties and lost of reputation. This course will provide attendee with an overview of the federal regulations and guidelines governing the financial aspect of clinical research.
Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Carolyn Troiano
90 Min
Product Id: 706938
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II
Robert J Russell
90 Min
Product Id: 701266
This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.
Violation...Deviation: Whatever you call them, you need a process to manage them
Tina D Forrister
60 Min
Product Id: 701125
This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.
Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges - part 1
Michael Drues
90 Min
Product Id: 701158
This Medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges. Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!
Principal Investigator responsibility in Research Involving Human Subjects: The International Conference on Harmonization (ICH) view
Charles H Pierce
90 Min
Product Id: 701077
This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.
How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits
Elizabeth Bergan
90 Min
Product Id: 701054
This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities
Elizabeth Bergan
Product Id: 701095
FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject’s welfare/rights. This course will provide an overview of the Clinical Trial Process. It will discuss in detail the responsibilities of the Sponsor (company or institution managing the trial) and Investigators conducting a clinical trial.
Quality Expectations for Drugs and Biologics during Early Development: Phase 3 and NDA
Steven S Kuwahara
75 Min
Product Id: 701011
This presentation will discuss the quality-related activities that are expected for Phase 3 products used in clinical studies and the needs of the key demonstration lots that will be submitted with the NDA. This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
Charles H Pierce
90 Min
Product Id: 701075
This FDA audit training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Data keeping for clinical research trials involving human subjects has to be as accurate and valid as possible. Does yours meet the mark?
Deploying Regulatory-Compliant Clinical Research Data Management Systems
Dale Hunscher
60 Min
Product Id: 701068
This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators. Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining". Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.