Clinical Trials Regulatory Compliance Training - Live Webinars, Recordings & CDs

Attend this webinar to learn how to shorten the timeline for key deliverables such as case report form Design, database build, and duration between last patient out and database lock without negatively impacting data quality or putting data integrity at risk.It will cover useful tips and guidance about the activities that may be streamlined without reducing quality and budget considerations. The webinar will cover warnings about quality steps that should not be eliminated or short-changed in a rush to get done faster.

Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.

This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

This webinar will discuss the overall impact of the updated GCP ICH E6 (R2) Addendum and what this means for you, your company and selected vendors.

This webinar will provide a basic understanding of how devices work, how to identify quality devices, how to get the most value from the information collected, and how to be well positioned for the growth in this field. The new mobile devices guidelines provided by the Clinical Trials Transformation Initiative (CTTI, a private/public partnership initiated by Duke University and the FDA) will be reviewed.

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, 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 Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.

This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).

This risk based clinical trial webinar will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials.

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

This webinar will discuss the new GDPR regulation requirements in the context of clinical trial data, how it applies to clinical trials and pharma industry, the personal data types including clinical trial data, what are the rights of clinical trials subjects, data access requests, informed consent, how to transfer clinical trial data outside EU, data breach reporting, penalties and how to put a data governance program and process to comply with GDPR regulations.

This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is qualified and required to be registered, determining time frame for updates to be posted and reporting the results. It will explain HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov and provide the steps to registration process in clinicaltrials.gov site.