Clinical Research Regulations and Guidance Training - Live Webinars, Recordings & CDs

Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.

This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.

This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.

This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).

This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.

This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

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 Clinical compliance training will review the purpose of INDs and the process for obtaining an IND. Attendees will gain a complete understanding of the criteria for exemption and the impact an exemption has on a study.