CenterWatch

Webinars

To have your webinar included, please contact jobwatch@centerwatch.com.

May

May 2, 2017

Barnett International

Good Clinical Practice: Practical Application and Implementation

8:30 AM - 10:00 AM Eastern

Notes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.

May 2, 2017

Barnett International

FDA Medical Device Approval Process

3:00 PM - 4:30 PM Eastern

This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH guidance — Investigational Device Exemption (IDE) and abbreviated IDE processes. This is done by reviewing sponsor and investigator obligations, along with the principles of Good Clinical Practice (GCP). Definitions used by sponsors and regulatory authorities for device development will be reviewed. Participants will become familiar with the regulatory decision-making process used by the FDA and learn to navigate the approval pathways to market.

May 3, 2017

Barnett International

Regulatory Intelligence

12:00 PM - 1:30 PM Eastern

The constantly changing regulatory environment necessitates keeping abreast of current information from a variety of sources. Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. There is more to RI than keeping up with the latest regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, and competitor information are just a few of the valuable sources of information that can help regulatory affairs professionals to develop successful regulatory strategies.

May 4, 2017

Barnett International

Informed Consent Guidance: Regulatory Updates

11:00 AM - 12:30 PM Eastern

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It’s essential that a subject clearly understands the information and language in the consent form and that their rights, safety, and welfare are not jeopardized. This web seminar will review the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the March 2015 draft guidance, “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” Additionally, there will be discussion of some of the challenges faced in consenting pediatric subjects in trials of greater than minimal risk, the use of translators, and review of the use of electronic informed consent and electronic signatures.

May 5, 2017

Barnett International

eTMF Quality Oversight: A Risk-Based Approach

1:00 PM - 3:00 PM Eastern

When applied to electronic Trial Master File (eTMF) oversight, risk-based management is the combination of the potential of quality issues occurring and the impact these deficiencies may have on the integrity of the TMF and the overall Good Clinical Practice (GCP) impact on the study. The TMF is comprised of many records and documents, and a quality TMF is defined as a collection of records, which is complete, collected in a timely manner and comprised of quality records. In the past several years, regulatory agencies have been very clear in their expectation that a sponsor presents a quality TMF during an inspection.

May 8, 2017

Barnett International

Case Report Form Design, Strategy, and Standards Workshop

9:00 AM - 4:00 PM Eastern

According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”

May 10, 2017

Barnett International

Negotiation Skills for Clinical Research Professionals

12:00 PM - 1:30 PM Eastern

The ability to negotiate effectively is a core competency for all clinical research professionals. Yet many people find negotiating to be an intimidating experience. Take this interactive web seminar and dramatically improve your ability to negotiate in any situation. With specific examples and real world case studies drawn from clinical research, you will be able to immediately implement the skills you learn with ease. This web seminar will provide a rich learning experience in implementing negotiation best practices.

May 10, 2017

Barnett International

Strategies for Building High-Performing Clinical Research Teams

2:00 PM - 3:30 PM Eastern

Creating and maintaining strong, productive teams is essential for success in clinical research. Teams from all parts of the research organization, including the clinical research site, the sponsor organization, Contract Research Organizations and a variety of other vendors all need to work effectively together to meet study requirements including Good Clinical Practice, project schedules and the study budget.

May 11, 2017

Barnett International

EU Clinical Trial Regulation 536/2014: Clinical Trial Applications and Amendments

9:30 AM - 11:00 AM Eastern

This web seminar reviews clinical trial applications and the EU single authorization process including Part I and Part II assessment reviews/reports/determinations as well as the EU portal for sponsor and European Medicines Agency (EMA)/Member State communications.

May 15, 2017

Barnett International

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

9:00 AM - 11:00 AM Eastern

ICH GCP E6 R2 is the first revision in 20 years and includes changes that are prescriptive, detailed and more consistent with the rapid, ongoing changes in the complexity and rising cost of clinical trials. Understanding these changes and how they impact your organization is the first critical step towards implementation. This web seminar will describe the addendums in a step-by-step process and provide a parallel discussion of how the revised guideline can improve efficient approaches to trial management. Discussion topics include: The effects on sponsors/CROs; clinical trial design; trial conduct and monitoring; and oversight/documentation and reporting. Practical information on how to incorporate the revisions to better manage human subject projection, understand the new definitions for monitoring plan, certified copy, and computerized systems, explore changed responsibilities to ensure data quality and integrity will also be provided.

May 15, 2017

Barnett International

Monitoring Oncology Clinical Trials

10:00 AM - 1:30 PM Eastern

This course is designed for Clinical Research Associates (CRAs) currently working in the industry who are interested in gaining knowledge about monitoring in the oncology therapeutic area. As the demand for CRAs in the oncology arena continues to grow, this course offers practical, hands-on training covering oncology-specific logistical, clinical, and ethical considerations. The application of clinical monitoring skills to oncology trials is reinforced through interactive discussions, case studies, and practice-based activities. The course content is also valuable to Project Managers and CRA Managers working in the oncology field as they seek to design feasible protocols, clinical monitoring plans, and monitoring tools adaptable to the unique requirements of these study sites and trials.

May 15, 2017

Barnett International

CAP and CLIA Requirements for Clinical Research Laboratories

1:00 PM - 3:00 PM Eastern

This web seminar will provide a general overview of the College of American Pathologists (CAP) and Clinical Laboratory Improvements Amendments (CLIA) requirements for laboratories that perform routine and non-routine testing of clinical samples for clinical trials. We will review the laboratory requirements for patient care and the requirements for clinical research. Similarities and difference of CAP requirements from ISO 15189 Medical Laboratories Requirements for Quality and Compliance, as applicable, will be discussed. This web seminar provides training for the auditor/inspector assessing clinical laboratories for compliance.

May 16, 2017

Barnett International

Quality by Design in Clinical Research: Is This Only for the Protocol?

11:00 AM - 12:30 PM Eastern

Over the past few years, Quality by Design (QbD) for clinical trials has been a focus for protocol development and execution. However, even though it is increasingly expected of the industry by regulatory agencies, translating this QbD approach into “building in quality for the business” is rarely shared for the “how do I do this?” This web seminar will de-code and translate QbD and quality for the research enterprise with examples that will solidify the concepts and framework presented for use within any organization.

May 16, 2017

Barnett International

Data Management Plan Creation: Content and Rationale

1:00 PM - 2:30 PM Eastern

A well-designed Data Management Plan (DMP) provides a detailed description of how to handle data under any foreseeable circumstances and establishes processes for how to deal with unplanned issues. The DMP is study specific, is considered a “living document,” and is subject to audit; therefore, it is important to understand the content requirements and rationale for its creation. In this web seminar, we will focus on the importance of the creation of a DMP and the expected content that this document should contain. Attendees will be provided with a sample template for review.

May 17, 2017

Barnett International

Quality Risk Management in Clinical Trials and Pharmacovigilance

12:00 PM - 1:30 PM Eastern

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

May 17, 2017

Barnett International

EMA and FDA Inspections: Key Differences and Similarities

1:00 PM - 2:30 PM Eastern

In this web seminar, key differences and similarities between the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) inspection procedures and processes will be discussed, including their collaborations on official joint Good Clinical Practice (GCP) inspections of sponsors, CROs, and investigational sites. The published results of the Pilot EMA-FDA GCP Initiative will also be reviewed using recent examples of joint inspections. Clarification will be provided for reporting of Serious Breaches in the United Kingdom along with a review of common inspection findings.

May 18, 2017

Barnett International

Monitoring Medical Device Trials: An Introduction

1:00 PM - 2:30 PM Eastern

This web seminar will provide the core concepts involved in monitoring medical device studies, including activities conducted at the investigator site, communication between monitor visits, and monitoring with centralized systems. We will explore the monitoring concepts as provided by the FDA in the Risk-Based Monitoring Guidance, as well as the ICH as interpreted for medical device trials. The basics of clinical monitoring and appropriate documentation to support adequate oversight of the study will be covered. Sponsor responsibilities and the role of the Clinical Research Associate/Monitor will be explored.

May 19, 2017

Barnett International

30-Hour Clinical Project Management Fundamentals Certification Program

12:00 PM - 3:00 PM Eastern

In today’s outsourcing environment, the need for strong project management skills is greater than ever. This comprehensive hands-on 30-hour course is designed to provide the tools necessary to become a strong project manager in clinical research. Whether you are looking to become a clinical research project manager, you are already in an entry-level project manager role or you have become an “accidental” project manager by assignment, this program will provide you with project management skills development as well as the necessary tools and processes required to successfully manage projects in clinical research settings.

May 22, 2017

Barnett International

Good Clinical Practice: Practical Application and Implementation

12:30 PM - 2:30 PM Eastern

This web seminar provides an overview of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This web seminar is designed for professionals with at least two years of experience in the clinical research industry.

May 23, 2017

Barnett International

Final ICH GCP E6 R2: Impact on Clinical Data Management

1:00 PM - 2:30 PM Eastern

Clinical Data Management plays a significant role in the performance of clinical trials. ICH GCP E6 R2 reinforces the requirements in regards to electronic systems and the Standard Operating Procedures (SOPs) that govern processes specific to these systems. In this web seminar, a review of these requirements as well as an examination of the components of quality management are covered. Further, the role that risk has on the overall conduct of clinical trials will be discussed, particularly since this concept will be the standard way forward (rather than an option). We will also review recommended approaches, industry standards/best practices to achieve compliance with the requirements.

May 23, 2017

Barnett International

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

2:00 PM - 3:30 PM Eastern

Both 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 scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

May 24, 2017

Barnett International

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

1:00 PM - 2:30 PM Eastern

In an effort to increase transparency, highlight potential conflicts of interest, and ultimately decrease healthcare costs, one element of the Patient Protection and Affordable Care Act (PPACA) – the Sunshine Act – requires disclosure of payments or transfer of value to physicians. These physicians can also be involved in clinical research as Investigators, in which case additional information is required to be reported. Released in February 2013, the final rule requires applicable manufacturers of covered drugs, devices, and biological supplies to gather and report information to be listed on the public website. This web seminar will address the requirements for reporting of information derived from clinical research as well as exceptions for reporting.

May 25, 2017

Barnett International

Risk-Based Auditing: Effective Compliance Strategies

12:30 PM - 2:30 PM Eastern

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

May 30, 2017

Barnett International

Good Laboratory Practice for Non-Clinical Studies

9:30 AM - 11:30 AM Eastern

This web seminar will provide a general overview of the regulatory requirements for non-clinical studies conducted at both pre-clinical facilities as well as bio-analytical laboratories. The course is divided into two sessions: The first session will focus on general regulatory requirements from the facility and the organization’s perspective and the second session will focus on audits conducted per study. This web seminar provides training for the pre-clinical facility and the bio-analytical laboratory personnel as well as quality assurance staff on maintaining compliance to 21 CFR Part 58.

May 30, 2017

Barnett International

SDTM and CDASH: What's the Connection?

1:00 PM - 2:30 PM Eastern

Currently, the FDA requires that clinical trial data be electronically submitted in the Clinical Data Interchange Standards Consortium (CDISC) format for consideration for a new drug/biological approval. A significant element in this submission is the Study Data Tabulation Model (SDTM). This web seminar will examine the information defining the concepts of the SDTM as presented in the documentation Version 1.4. The purpose of data standards, benefits of applying these standards, and the relationship between datasets and records will be examined. The relationship between the standard for data collection instruments — also known as Clinical Data Acquisition Standards Harmonization (CDASH) standards — and the standard data format in which the data will be presented will also be discussed.

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