Відео

The EU Clinical Trial Regulation (Regulation (EU) No. 536/2014) has ushered in a transformative era for clinical trials within the European Union and is built on three fundamental pillars: Enhancing the efficiency of clinical trials in Member States Concerned (MSCs) to foster innovation and reduce duplication, increasing the transparency of clinical trials across Europe, and prioritizing partic...

While ICH E6 (R2) incorporated evolutions in technology and risk management processes to better reflect changes in the scale, complexity, and cost of clinical trials, the draft ICH E6 (R3) focuses on clinical trials’ critical-to-quality factors that support the fundamental goal of Good Clinical Practice (GCP): Credible data from protected participants. Reimagined to align with, and support, key...

In January 2017, the ICH GCP renovation was initiated, ushering in a new era of regulatory guidelines. The finalization of ICH E8 R1 in 2021 has brought forth a clear roadmap for integrating Quality by Design principles into the design and development of clinical trials. Simultaneously, the draft version of ICH GCP (ICH E6 R3) includes a complete rewrite of existing guidelines, triggering a par...

Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This web seminar will give learners an overview of writing practices, formatting, working with tables/figures, and communicating effectively. Practical applications of these skills will be described as they apply to wr...

Both the ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the s...

In January 2017, the ICH GCP renovation was initiated, ushering in a new era of regulatory guidelines. The finalization of ICH E8 R1 in 2021 has brought forth a clear roadmap for integrating Quality by Design principles into the design and development of clinical trials. Simultaneously, the draft version of ICH GCP (ICH E6 R3) includes a complete rewrite of existing guidelines, triggering a par...

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be ...

A Work Breakdown Structure (WBS) defines the work, tasks, assignments, and timelines for work to be completed. This web seminar identifies how WBS aids team members involved in study start-up from the sponsor/CRO and investigative site to address clinical trial start-up challenges once an investigative site has been selected. Recommendations on how sponsors/ CROs and investigative sites work co...

The premise behind RBQM is that monitoring quality can be improved by leveraging existing data. The development of quality and risk management metrics involves identifying the values of an organization, and this web seminar will focus on developing measures to assess meeting those goals, building infrastructure to capture data to support the metrics, and establishing adequate and timely respons...

The primary reason the FDA performs inspections is to support its mission to protect the public by ensuring the safety and efficacy of drugs, biologics, and medical devices. In 2006, the FDA announced an initiative to modernize the regulation of clinical trials, including the Compliance Program Guidance Manual (CPGM) Bioresearch Monitoring Program (BIMO). The purpose of the FDA compliance progr...

ICH E8 (R1) is intended to identify and modernize the present conduct of clinical research, including clinical trial design, planning, management, and conduct. In clinical research, quality assurance activities of retrospective document checking, monitoring, auditing, or inspection are essential, and there has been an overreliance on these tasks versus relying on designing quality into clinical...

The Trial Master File (TMF) is a collection of the essential documents for a sponsor to demonstrate that they have fulfilled their obligations as sponsor for a clinical trial project as defined by the health authorities. This web seminar reviews the activities that a sponsor uses to set-up, maintain, and perform oversight of the TMF. It examines the changing regulatory landscape that defines sp...

The stipulation of taking a more proactive approach to managing risk in clinical trials is a major component of ICH GCP E6. As outsourcing in clinical development continues to grow, so do the challenges of ensuring quality outcomes. In this web seminar, recommendations for sponsor oversight practices are discussed, as well as tools and best practices for managing vendor relationships. Managing ...

Non-compliance at research sites requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: Ultimately improved...

Managing Phase I Clinical Trials

CRO Partner Management

Overseeing Teams and Projects

Introduction to Statistics for Non-Statisticians

ICH GCP E6 R2 and R3 Updates Implementing Risk Management Approaches for Compliance

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025

Introduction to Statistics for Non Statisticians

ICH E6 (R3) and ICH E8 (R1)Updates: Impact on Sponsors

FDA’s Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance

ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors

Developing Clinical Study Budgets for Sponsors

Risk-Based Monitoring & Quality Mgmt of Clinical Trials: Recent Guidance Updates from FDA & EMA

ClinicalTrials.Gov Requirements

Electronic Medical Records: Approaches for Ensuring Source Document & 21 CFR Part 11 Req. Components