Clinical Research Trial Design and Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.

This training program will identify regulations and guidelines pertaining to institutional review boards. Attendees will learn about the historical events leading up to today’s regulatory framework in clinical research as well as discuss recent ethical issues regarding the IRB. The course will also explore the emergence of IRBs that are not academically affiliated.

This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.

This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.

This training program will explain what the critical areas and elements of vendor oversight are and how you can set such a system up for yourself at your company.

This training program will take an in-depth look at various clinical research contracts designed for different purposes. Understanding each type including what is being protected and who is being protected is an important part of ensuring compliant administration and management of clinical research activities. Beyond the legal terms, this course will examine the standards for accredited organizations and best practices for ensuring the broadest protections for study participants.

This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.

This program will identify regulations and guidelines pertaining to investigational device exemptions. Participants will learn to translate regulations and guidelines into practical application. The program will also discuss the dos/don’ts for conducting device trial activities through real-life examples.

This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

This training program will critically assess the number of major and critical 2012 inspection findings related to trial oversight. Attendees will learn to identify regulatory requirements for appropriate delegation of duties and investigator oversight.

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.

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.

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.

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.

This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.