CenterWatch

Training Programs

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

April

April 4-5, 2017

Comprehensive CRC Training
Boston, MA

This course provides an in-depth survey of the roles and responsibilities of the investigator site Clinical Research Coordinator (CRC). The course begins with an overview of the drug development process and regulatory environment in which the CRC operates. From there, critical CRC responsibilities will be discussed, including patient recruitment and retention, informed consent, adverse event reporting, and investigational product accountability. The CRC’s role at the site will be explored, from study start-up through site close-out, and all of the activities, site visits, and documentation that occur along the way. Finally, site audits and inspections will be reviewed, with an emphasis on the CRC’s role in that process.

Take advantage of our $1,595.00 price by registering early! * After March 3, costs are $1,795.00.

April 4-5, 2017

Good Clinical Practice Regulatory Changes, Trends, and Best Practices Implementation
Boston, MA

This course will review recent FDA guidance documents and general regulatory trends, including revisions to ICH GCP E6 R2 and the repeal of the EU Clinical Trial Directive with replacement with the EU Clinical Trial Regulation 536/2014. With a number of new FDA guidances released over the past several years related to investigator oversight, risk-based monitoring, electronic medical records, and electronic informed consent, the industry must consider the trends and what the regulatory agencies are focusing on. We are seeing revisions in the U.S. and EU related to risk management and oversight that sponsors and sites should be prepared to implement with best practices. With the availability of multiple electronic resources there is an expectation to review information in real time; however, we still need to consider resources, confidentiality, and applications in a global research environment. In this session we will discuss recent trends, upcoming changes and how to design best practices in an evolving clinical research world.

Take advantage of our $1,595.00 price by registering early! * After March 3, costs are $1,795.00.

April 17, 2017

Becoming a Clinical Research Investigator: Expectations and Responsibilities
San Francisco, CA

Industry trends indicate that the majority of physicians who participate in a research study do not return to do another. This costs the industry time, money and frustration in trying to identify new investigators, ensure adequate training, and support compliance at inexperienced sites. Additionally, the cost to the physicians acting as an investigator for the first time are possible loss of income, more time spent than anticipated, frustration, and possible inspection findings that are publically posted. In this course, the core requirements, regulatory expectations, and practical approaches to becoming an industry research investigator are covered. Included are the expectations for setting up a research site and staff, what questions investigators should ask before taking on a study, and ongoing regulatory requirements for investigator oversight and Good Clinical Practices (GCPs). FDA regulations and applicable guidance documents will be explored as well as ICH GCP E6 for application to international trials.

Take advantage of our $800.00 price by registering early! * After March 16, costs are $1,000.00.

April 18-19, 2017

Basics of Post-Marketing Pharmacovigilance and the Beginner PV Auditor
Boston, MA

As of 2012, the “gold” standard of pharmacovigilance (PV) and adverse event (AE) reporting on a global level is based on the European Medicines Agency (EMA) PV Modules, which require that Quality Assurance (QA) be part of the quality management system (QMS), and that PV audits be performed at various levels and at varying sites. Although most Good Clinical Practice (GCP) experts are familiar with pre-marketing drug safety, there is a difference to post-marketing PV and the associated activities.

This is an introductory course for those unfamiliar with the EMA PV Modules or global reporting requirements The basics of EMA (and FDA) expectations on the receipt, processing, reporting, and management of AEs for marketed products (drug and device), and how to prepare for auditing these systems will be presented. Learners will be shown the basic concepts of reportable events, timelines of reporting, what the global PV department is responsible for, and the audit process to be applied for both systematic internal audits as well as at affiliated offices and PV vendors. The course will include presentations, discussions, and problem solving techniques using case studies applicable to both drug and device marketed products. Exercises are designed to help you understand what the PV process actually is and how to apply an auditing perspective.

Take advantage of our $1,595.00 price by registering early! * After March 16, costs are $1,795.00.

April 18-19, 2017

Clinical Project Management Advanced
San Diego, CA

This course provides the experienced project manager the additional skills they need to lead clinical trials to optimal performance. This two-day course builds upon basic and intermediate clinical research trial management skills benchmarking to Project Management Institute®, PMBOK as it applies to clinical trial management, including effective use of the project manager’s communication and leadership skills to overcome difficult issues a project manager may encounter. Advanced concepts will be presented to explore how project managers effectively: Prioritize project needs, influence, lead project teams and stakeholders, and utilize best practices for documentation of project and team decisions. Operational challenges will also be explored in addressing vendor lifecycle management, assessment of risk (project, quality), issue management with the use of root cause analysis, and corrective and preventive action plans for effective management. All concepts are presented in a dynamic, interactive manner to facilitate learning and retention.

Take advantage of our $1,595.00 price by registering early! * After March 16, costs are $1,795.00.

April 18-20, 2017

Comprehensive Monitoring for Medical Devices
San Francisco, CA

This course provides an in-depth overview of the medical device development process and the role of the Clinical Research Associate (CRA) in managing and monitoring medical device studies. This course is ideal for CRAs new to the device industry, as well as experienced CRAs who are transitioning from monitoring drug studies to monitoring device studies.

Take advantage of our $1,695.00 price by registering early! * After March 16, costs are $1,895.00.

April 18-19, 2017

Monitoring Clinical Drug Studies: Advanced
Boston, MA

This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non- compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.

Take advantage of our $1,595.00 price by registering early! * After March 16, costs are $1,795.00.

April 25-26, 2017

Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions
San Diego, CA

The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the Agency about the proposed development plan, keep the Agency up to date and answer any questions the Agency has about an on-going investigation, request and prepare for meetings with the Agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner.

May

May 10-11, 2017

Working with CROs: Building a Partnership for Project Success
San Diego, CA

This course provides an in-depth overview of Contract Research Organization (CRO) evaluation,selection, management, and trouble shooting. Various types of CRO relationships will be addressed including outsourcing to lab vendors,niche specialty providers, data management,and overall study management and monitoring. Beginning with a review of the Request for Proposal (RFP) process, the course will take you through follow-up analysis and debriefing of the CRO partnership.

Take advantage of our $1,595.00 price by registering early! * After April 7, costs are $1,795.00

May 12, 2017

Developing Effective Training and Facilitation Skills in Clinical Research: An Application-Based Course
San Diego, CA

In clinical research, there is an ongoing need to conduct training whether it is at the onset of a study, due to a change in staff or new staff, as a result of an amendment, or because of an identified noncompliance during a study. How we approach and deliver training is important. Delivering hours’ worth of PowerPoint presentations does not facilitate learning or identify where the knowledge gaps may lie in order to make the best use of time and resources.

Take advantage of our $800.00 price by registering early!* After April 7, costs are $1,000.00.

May 16-17, 2017

Conducting Clinical Trials Under ICH GCP E6
Boston, MA

This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the FDA will also be discussed.

Take advantage of our $1,595.00 price by registering early!* After April 13, costs are $1,795.00.

May 17, 2017

Investigator-Initiated Trials (IITs) and the Role and Responsibilities of the Investigator
Philadelphia, PA

This course provides an overview of the applicable regulations for Investigator-Initiated Trials (IITs), including the role and responsibilities of the individual investigator who acts as an investigator and a sponsor in conducting the study. The seminar includes a review of the reporting requirements and essential documentation required for these trials, and illustrates the risks involved. Tips on how to avoid the common pitfalls are addressed, including examples from FDA inspections and how to prepare for a possible inspection.

Take advantage of our $800.00 price by registering early!* After April 13, costs are $1,000.00.

May 18, 2017

Developing Clinical Study Budgets
Philadelphia, PA

This course provides the practical skills needed to construct and negotiate study budgets that appropriately compensate investigative sites for resource needs required as a result of clinical research protocols.

Take advantage of our $800.00 price by registering early!* After April 14, costs are $1,000.00.

May 19, 2017

How to Write Effective Monitoring Reports and Communications
Philadelphia, PA

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial.

Take advantage of our $800.00 price by registering early!* After April 14, costs are $1,000.00.

May 23-24, 2017

Clinical Project Management: Introduction to Practical Clinical Trial Planning for Project Managers
Boston, MA

This course is an introduction to clinical project management in the pharmaceutical industry. The focus is on individuals who want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials. The needs of relatively new project managers who are not familiar, or experienced, with specific technical tasks involved in clinical trial management are addressed.

Take advantage of our $1,595.00 price by registering early!* After May 26, costs are $1,795.00.

May 23-24, 2017

Introduction to Clinical Research
Boston, MA

This two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable.

Take advantage of our $1,595.00 price by registering early!* After April 21, costs are $1,795.00.

May 23-24, 2017

Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
Boston, MA

Managing investigator noncompliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify noncompliance, correct the non-compliance through intervention, and evaluate the effectiveness of the intervention. Root cause analysis provides a process through which issues can be accurately identified and interventions can be effectively designed.

Take advantage of our $1,595.00 price by registering early!* After April 21, costs are $1,795.00.

June

June 20-22, 2017

Monitoring Clinical Drug Studies: Beginner
Boston, MA

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. Best practice techniques for site management will be provided, and activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts. This is a practical, hands-on introduction to the job and how clinical monitoring tasks are performed.

Take advantage of our $1,695.00 price by registering early!* After May 12, costs are $1,895.00.