CenterWatch

Webinars

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

April

April 26, 2016

Barnett International

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

9:30 AM - 11:00 AM 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.

April 26, 2016

Barnett International

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

12:30 PM - 2:30 PM Eastern

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

April 27, 2016

Barnett International

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

12:00 PM - 1:30 PM Eastern

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

April 28, 2016

Barnett International

Source Documentation: What is Adequate & Accurate?

9:30 AM - 11:30 AM Eastern

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

April 28, 2016

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).

April 28, 2016

Barnett International

Current FDA and EMA Inspection Findings: Lessons Learned

1:00 PM - 2:30 PM Eastern

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of 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 some of the top 10 inspection findings from the Annual BIMO Inspection Metrics, and discuss appropriate corrective and preventive actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again. Learners are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for ICH-GCP compliance. Tools will be provided to assist clinical research personnel in their efforts to be ICH-GCP compliant.

April 28 - June 30, 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.

April 29, 2016

Barnett International

Monitoring Phase I Clinical Trials

12:00 PM - 2:00 PM Eastern

Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review specific components for monitoring studies in this phase of research. References from GCP to support monitoring activities will be presented, as well as case studies to apply presented concepts.

May

May 2, 2016

Barnett International

CRO Partnership Management

1:00 PM - 2:30 PM Eastern

In an environment where we are outsourcing multiple tasks, it is valuable to understand the dynamics of relationship building and the application of practical management. Extensive knowledge and skill are required to manage large teams, especially when the majority of the team functions outside of your organization. This web seminar provides an overview of Contract Research Organization (CRO) partnership building, management, application of root cause analysis (RCA) and strategies for problem solving.

May 2, 2016

Barnett International

Monitoring Oncology Clinical Trials

1:00 PM - 3:00 PM Eastern

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

May 3, 2016

Barnett International

Auditor Emotional Intelligence

1:00 PM - 3:00 PM Eastern

Audits are often viewed as transactional and factual – and rightly so! They are transactional (a process carried out) and must be factual, devoid of as much personal bias and emotion as possible. However, the power of advanced soft skills in enhancing both the transactional and factual aspects of an audit cannot be underestimated. We have all heard stories of painful audits with auditors who possessed little to no soft skills. The use of appropriate, advanced soft skills serves to reinforce a culture of quality with the auditee. The most important soft skill a quality professional can possess is emotional intelligence.

May 4, 2016

Barnett International

Preparing Clinical Research Sites for FDA Inspections

12:00 PM - 2:30 PM Eastern

This web seminar is designed for participants that are sponsors/CROs and research site representatives preparing for a research site FDA inspection. From audit readiness to action item resolution, each site faces its own unique challenges. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.

May 4, 2016

Barnett International

Re-Engineering the RFP and Bid Defense Meeting to Effectively Manage Risk and Quality

12:00 PM - 2:30 PM Eastern

In this web seminar, we will review the re-engineering of the Request for Proposal (RFP) and bid defense meeting to target identification of risks for the potential services to be awarded to your CRO, vendor, or supplier, whether a preferred partnership model, a “company approved list,” or based solely on project needs. This approach also gives the provider the opportunity to communicate their ability and willingness to adjust their approach and methods beyond the RFP, thus beginning a dialogue regarding management and quality oversight methods early on in the partnership. This improved process drives business efficiencies and cost savings now, rather than later during trial execution, and helps identify impact on protocol and data integrity if performance is inadequate.

May 4, 2016

Barnett International

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

3:00 PM - 4:30 PM Eastern

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 human subject protections and data integrity. Lack of these components can lead to repeated non-compliance and in some cases to rejection of corrective action plans by regulatory authorities.

May 4, 2016

Barnett International

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

3:00 PM - 4:30 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. We will discuss the critical first step of defining quality; how to simplify QbD; how QbD and Quality Management Systems (QMS) relate to each other; determining whether your organization has these in place; what the best QbD principles and methods are; how to go beyond plans and create checklists for quality; and, finally, strategies for effective implementation.

May 5, 2016

Barnett International

Root Cause Analysis: Applying the Concept for Better Study Compliance Management

12:00 PM - 2:30 PM Eastern

Managing compliance in the research industry is vital to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, intervene, and then evaluate the effectiveness of the intervention. Without root cause analysis, interventions cannot be effectively identified and designed. This web seminar will present the scientific concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research, the sponsor, CRO, site, and Institutional Review Board (IRB).

May 6, 2016

Barnett International

Phase I Study Management

12:00 PM - 1:30 PM Eastern

Because the early life of a compound is dependent on the data and analysis derived from Phase I Studies, it is imperative that these trials are managed and conducted with the highest quality and care. Therefore, well-honed project management skills that can address the unique issues associated with Phase I Studies are needed. This web seminar will examine the importance of Phase I Studies in drug development, the issues commonly associated with conducting a Phase I Study from a sponsor perspective and provide project management best practices specific to overseeing a Phase I Study.

May 9, 2016

Barnett International

ABCs of GCP and the 13 Principles of ICH

9:30 AM - 11:00 AM Eastern

This web seminar provides the basic concept of Good Clinical Practice (GCP). Participants will learn the goals of GCP and its common elements (FDA regulations and ICH Guidelines) defining the quality system of mutual accountability between the sponsor, investigator, IRB/IEC, and the regulatory authority. The basic roles and responsibilities of each stakeholder will be discussed in relation to these criteria. The 13 principles of ICH GCP will be discussed in a practical manner to ensure compliance with all regulatory requirements.

May 9, 2016

Barnett International

Applied Clinical Statistics in Centralized Monitoring

9:30 AM - 11:00 AM 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. These tools are also flexible towards clinical business operations. Attendees will learn to interpret and graph histograms, quantify risk in histograms and datasets, identify clinical trial underperformance, and utilize minimum random sampling for RBM in histograms and datasets.

May 9, 2016

Barnett International

ABCs of Clinical Research for Clinical Administrative Support Staff

12:30 PM - 3:00 PM Eastern

This course provides the background needed to become an integral part of the clinical research team (for drugs and devices) and explores the need to understand the rationale behind quality performance and team-playing. The roles and responsibilities of Clinical Administrative Support will be discussed in terms of obligations to the study team and the importance of compliance with Standard Operating Procedures and Standard Office Practices. Although the course is designed for administrative staff with less than one year experience, those with some experience may also find this course helpful in providing the rationale for doing tasks in a specific manner, refining their skills, and sharing their experiences and helpful techniques with their colleagues.

May 9, 2016

Barnett International

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

1:00 PM - 3:00 PM Eastern

RECIST stands for Response Evaluation Criteria in Solid Tumors. The National Cancer Institute is the best resource for information, and defines RECIST criteria as “a voluntary, international standard, and not an NCI standard. They are based on a simplification of former methods (WHO, ECOG) and based on measurable disease, i.e., the presence of at least one measurable lesion.” RECIST criteria provide a way to standardize measurement of solid tumors worldwide for any clinical trials that include this data to define study endpoints.

May 10, 2016

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

8:30 AM - 11:30 AM 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.

May 10, 2016

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

12:00 PM - 2:00 PM 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.

May 10, 2016

Barnett International

Monitoring Visit Reports for Medical Device Studies

3:00 PM - 4:30 PM 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.

May 11, 2016

Barnett International

Writing and Maintaining the EU CTA (Clinical Trial Authorization)

12:00 PM - 3:00 PM Eastern

The Regulatory Affairs department must prepare documents that inform European Regulatory Agencies about the proposed development plan; submit a Clinical Trial Authorization (CTA) to initiate human clinical trials; answer questions about on-going investigations; and construct and submit any updates to the CTA in a concise and informative manner. Regulatory submissions are more than just writing – they encompass strategy, research, writing, organizing and leading a team, compiling, editing, publishing, and tracking of the information. When initiating a global clinical trial program, many moving parts need to be brought into harmony to ensure compliance and that timelines are met. Web seminar attendees will walk away with tools to help plan, write, and manage multiple CTAs with all their differing requirements.