CenterWatch

Webinars

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

February

February 9, 2016

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

9:30 AM - 11:30 AM Eastern

Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.

February 9, 2016

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

12:00 PM - 3:00 PM Eastern

The Clinical Research Associate (CRA) creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

February 9, 2016

Barnett International

Informed Consent Procedure: Lessons Learned from Inspection Findings

1:00 PM - 2:30 PM Eastern

Informed consent irregularities remain one of the leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of FDA Warning Letters addressing informed consent inspection findings, and discuss appropriate corrective and preventive actions (CAPA). Learners will come away with solutions to avoid common informed consent pitfalls, and ultimately, avoid inspection findings. Participants are encouraged to share their experiences as we discuss methods to aid in compliance through appropriate techniques for the informed consent process. Tools will also be provided to assist in compliance.

February 10, 2016

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

1:00 PM - 2:30 PM Eastern

As many organizations move to, or contemplate, a risk-based approach to trial conduct and quality management, the published regulatory agency documents and industry think tank publications fall short in providing sponsors, CROs, and clinical vendors the framework—a comprehensive, systematic, structured approach to implementing risk management. This web seminar will provide an overview of a risk management reference model for use that has been adopted by other industries and is referenced in the FDA Guidance of 2013, “Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring.”

February 10, 2016

Barnett International

ICH E-6 GCP Proposed Revisions 2016 Review: Impact on Sites, Sponsors, and CROs

3:00 PM - 5:00 PM Eastern

For the first time in 20 years, the International Conference for Harmonization (ICH) E-6 Good Clinical Practice (GCP) Guideline is being updated. The proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. But, the proposed changes have resounding effects and impact on Sponsors and Investigators, requiring a complete and systematic analysis to ensure adherence to these proposed clinical trial standards. This web seminar not only informs learners of the proposed changes, but also provides information and techniques for a constructive and systematic approach in assessing organizational practices and designing any modifications.

February 10, 2016

Barnett International

Sponsor Responsibilities for Global Drug Studies

3:00 PM - 4:30 PM Eastern

This web seminar covers the sponsor’s responsibilities for the conduct of a global drug study. Participants will learn the 23 responsibilities assigned to a sponsor for a global clinical study based on the International Conference on Harmonization (ICH) requirements. These essential requirements for compliance to regulations are useful when dealing with the FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and Health Canada (HC), among other global regulatory authorities. Focusing on the importance of documentation, participants will learn how to put these concepts into practice.

February 11 - April 21, 2016

Barnett International

30-Hour Clinical Research Auditing Certification Program

6:00 PM - 9:00 PM Eastern

The online 10-Week Clinical Research Auditing Certification Program provides a comprehensive introduction to clinical research and the job function of the Clinical Quality Assurance Auditor for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.

February 12, 2016

Barnett International

Centralized TMF Management: The CRO Sponsor Partnership

9:30 AM - 11:00 AM Eastern

Many sponsor organizations transfer responsibility for Trial Master File (TMF) management to their Contract Research Organization (CRO) partners. However, the CRO maintains TMF content for those activities for which they have been delegated. Generally a TMF is comprised of sponsor, CRO, and vendor content. The relationship between the CRO and the sponsor is critical in ensuring a quality TMF. This web seminar will explore critical activities and responsibilities on the part of the CRO and the sponsor. A successful partnership between these two groups is critical to ensuring an inspection ready file during and at the conclusion of the study

February 12, 2016

Barnett International

Applied Clinical Statistics in Centralized Monitoring

1:00 PM - 2:30 PM Eastern

With the release of FDA’s guidance on risk-based monitoring (RBM), the FDA is requiring centralized monitors to have adequate training to perform centralized monitoring activities. Moreover, with the increase in the availability of clinical operational data, and with more biopharmaceutical and medical device enterprises outsourcing, clinical operations teams need to have the necessary skills to centrally and efficiently monitor and manage their clinical trials. This web seminar will provide a brief background as to how the industry is changing, address why centralized and RBM is gaining importance, and offer applied clinical statistical training and tools that can be utilized towards centralized clinical trial monitoring applications and identifying site underperformance.

February 12, 2016

Barnett International

eTMF Implementation Strategies

1:00 PM - 3:00 PM Eastern

Across the industry, organizations are moving towards an electronic Trial Master File (eTMF). Moving from a paper TMF to an eTMF is a large undertaking for any organization. The right approach to the project is critical to the implementation. In this web seminar, we will discuss the key activities including vendor selection, developing eTMF management processes that ensure a high quality TMF, implications of eTMF within your organization, and working with Contract Research Organizations (CROs) and sponsor partners during the implementation process. Successful planning and implementation will result in a high quality eTMF system that ensures the organization is inspection and audit ready.

February 16, 2016

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicum

9:00 AM - 12:00 PM Eastern

This application-based web seminar covers advanced concepts and challenges encountered in the application of Good Clinical Practice (GCP). During this highly interactive course, participants will review and discuss cases that include GCP challenges in topic areas such as IRB/IEC approval, informed consent, drug accountability and reconciliation, SUSAR submissions, communications with ethics committees and health authorities, as well as the management of investigational product. Cases are based on actual industry examples, and participants are expected to solve cases by applying Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which are briefly reviewed.

February 16, 2016

Barnett International

Overseeing Teams and Projects

1:00 PM - 3:00 PM Eastern

According to a survey by Ernst & Young, 80% of the issues surrounding project failure are people issues. Project success requires that project managers not only manage projects, but lead people. To do so effectively, they must gain the knowledge, skills, tools, and experiences of other leaders to enable them to manage and lead both the technical and the people side of project management. In this web seminar, participants will review key components of effective communication skills to achieve peak team performance. Team leadership and management, negotiation and influencing skills will also be covered through the examination of different leadership styles and qualities that are required for successful project delivery.

February 22, 2016

Barnett International

FDA's Role in Device Safety Inspections

9:30 AM - 11:00 AM Eastern

The primary role of the FDA or other regulatory authority is to protect public health and ensure that devices are safe and effective. This is done by systematically reviewing all data to ensure it is valid and obtained under proper conditions. The FDA has authority to conduct inspections according to the Code of Federal Regulations. This web seminar examines the types of inspections conducted by the FDA and the mechanics of the inspection of a device sponsor as well as an investigational site. Participants will learn the most common audit findings and possible regulatory actions. Several FDA Warning Letters will be reviewed to demonstrate the thoroughness of a regulatory review. Tips will be provided for the management of the inspection activities both during and after the inspection.

February 22, 2016

Barnett International

Data Management in the Electronic Data Capture Arena

1:00 PM - 2:30 PM Eastern

This web seminar will explore the evolution of Clinical Data Management from a paper Case Report Form (CRF) process to the “real time” data review capable in the world of electronic data capture (EDC). We will review the specific regulations governing EDC and electronic signature requirements. Participants will examine the changing role of the Clinical Data Manager (CDM) as the technology drives the process, thereby allowing today’s CDM to move forward in the discipline and ensure their place as a viable member of the clinical study team. The EDC technology is enabling the data management component of clinical trial activities to advance and it is important that the CDM is aware of the capabilities the applications have to offer.

February 23, 2016

Barnett International

Introduction to Data Management

9:30 AM - 11:30 AM Eastern

This web seminar provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and other individuals who wish to learn basic clinical data management functions.

February 23, 2016

Barnett International

Data Quality in Clinical Trials: Rationale and Impact

12:30 PM - 2:30 PM Eastern

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

February 24, 2016

Barnett International

Risk-Based Monitoring: The Data Management Connection

12:30 PM - 2:30 PM Eastern

The final guidance, “Guidance for Industry: Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring” was released in August 2013. To quote from the new guidance, “… monitoring refers to the methods used by sponsors of investigational studies, or CROs delegated responsibilities for the conduct of IND studies, to oversee the conduct of and reporting of data from clinical investigations, including appropriate Clinical Investigator supervision of study site staff and third party contractors.”

February 25, 2016

Barnett International

European Pharmacovigilance Modules: What Are They and Why They Are Important

1:00 PM - 2:30 PM Eastern

Since 2012, the European Medicines Agency (EMA) has developed, published, and modified directives regarding Post-Marketing Pharmacovigilance (PV), simply known as the EMA PV Modules. These modules and the inspectors’ expectations are currently considered the pharmaceutical, biotechnology, and device industries “gold” standard for PV processes for companies that market products on a global basis. In this web seminar, learners will be provided with the basics of the EMA PV Modules, specifically, what are they and why they are important for the U.S.

February 26, 2016

Barnett International

eTMF Quality Oversight: A Risk-Based Approach

9:30 AM - 11:30 AM 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.

February 26, 2016

Barnett International

TMF/eTMF Audit Strategies

1:00 PM - 2:30 PM Eastern

The process for managing the Trial Master File (TMF) has changed drastically in the last 10 years. Many organizations have moved to an electronic TMF (eTMF), yet some organizations still operate with a paper TMF or a hybrid of the two. A successful audit evaluates the completeness of the entire TMF. This web seminar will present a strategy for conducting a TMF audit that identifies gaps that have potential impact on the quality of the TMF. We will explore strategies for using the power of an eTMF to identify gaps that could result in inspection findings.

February 29, 2016

Barnett International

Annual GCP Training Update: MHRA Inspection Findings for 2015

9:00 AM - 12:00 PM Eastern

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is one of the most exacting regulatory authorities in the world. Their specialist inspectors are highly trained to identify problems, deviations and discrepancies in clinical research. One of the best ways to learn about the inspectorate and its areas of focus is to consider the inspection findings which they have made. This web seminar will bring learners up-to-date on the current findings of the MHRA, which areas cause the regulator the most concern, and how they interpret the regulations and guidance to which they hold researchers accountable.

February 29, 2016

Barnett International

Monitoring Visit Reports for Medical Device Studies

9:30 AM - 11:00 AM Eastern

In this web seminar, we will discuss how to write effective monitoring visit reports for medical device studies. Participants will learn the purpose for monitoring investigational sites and the importance of documenting the visit. We will examine the requirements for the documentation in the Code of Federal Regulations and International Conference on Harmonization Guidelines, and discuss how the report is used by various stakeholders. Tools will be provided to enable learners to scrutinize various sections of the report to better document what was accomplished on the visit. This documentation supports the adequate monitoring obligation expected by regulatory authorities.

February 29, 2016

Barnett International

The Fundamentals of Clinical Research Project Management

12:00 PM - 1:30 PM Eastern

Participants will explore the principles of project management and apply project management tools to ensure the success of their clinical research projects. Participants will learn to develop a project charter, a work breakdown structure, a risk assessment and contingency plan, a process improvement plan, as well as how to lead without authority. Each participant will leave the session with tools and checklists to apply to their projects.

February 29, 2016

Barnett International

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada

12:30 PM - 2:30 PM Eastern

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. Regulatory agencies’ recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventive action plans are developed to secure compliance. This web seminar will examine the trends in recent regulatory communication and open discussion for review of acceptable versus unacceptable responses.

March

March 1, 2016

Barnett International

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

9:30 AM - 11:00 AM Eastern

Both ICH E6 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 ICH 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.

March 1, 2016

Barnett International

Data Management in the Electronic Data Capture Arena

10:30 AM - 2:00 PM Eastern

This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process.

March 1, 2016

Barnett International

Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspection

12:30 PM - 2:30 PM Eastern

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

March 2, 2016

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.

March 2, 2016

Barnett International

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

12:30 PM - 2:30 PM Eastern

Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This web seminar will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

March 3, 2016

Barnett International

Good Clinical Practice: Practical Application and Implementation

9:30 AM - 11:30 AM 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.

March 3, 2016

Barnett International

Preparation, Management, and Response to Inspections and Audits

10:00 AM - 2:00 PM Eastern

Faced with an impending audit or inspection, how do you prepare? If inspection results in findings, do you have the skills and tools to best respond to these issues to avoid further actions? This web seminar will provide an overview of what to expect and how to prepare for an audit or inspection. Real case scenarios in a workshop format will be used to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. Steps for preparation, on-site auditing and follow-up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs).

March 3, 2016

Barnett International

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

12:30 PM - 2:30 PM Eastern

As scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA’s current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.