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

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 webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.

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.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

Join Elaine Eisenbeisz for a 2-hour webinar as she presents some history behind the many ways of dealing with missing data. She will provide some statistical reasoning on the why and when of applying various techniques in working with missing-ness in data. Elaine will also discuss and demonstrate multiple imputation techniques using SPSS software.

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.

This Trial Master File training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using check-lists and case studies to highlight common deficiencies and potential solutions.

This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.

This Sunshine Act reporting webinar will discuss new requirements for manufacturers of healthcare products related to report of certain payments and items of value given to physicians and teaching hospitals. It will discuss the reporting format, exemptions and timeline for compliance and practical solutions to most common situations prevalent between sponsors and investigators.

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

Join this webinar which will discuss current, expert, and applicable knowledge about the responsibilities, functions, and management of SAE reporting and medical safety for a clinical trial. The procedures for SAE reporting will be discussed which should be contained in company SOPS and well organized with regard to staff assignments and responsibilities before a trial begins to assure all responsibilities are covered.

This webinar will discuss good clinical practice core principles and project management strategies applicable to financial aspects of clinical research during new biomedical product development process. Strategies and best practices to mitigate fiscal risks in clinical trials will be discussed i.e. coverage analysis, cost estimation, budgeting and billing Compliance.

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

In this revised ICH GCP guideline on budgeting and contracts for clinical trial webinar will discuss the impact of changes in ICH GCP E6 R2 on investigator, site, sponsors CROs roles and responsibilities and the impact of clinical trial conducts and organizational practices along with evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

This Good clinical research practices and auditing (GCP) webinar will teach how to get rid of challenges related to clinical practice in particular to data quality and regulatory risk proactively, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques.