CenterWatch

Training Programs

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

December

December 6-8, 2016

CRA & CRC Beginner Program
Philadelphia, PA

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC. Specifically, this course is appropriate for individuals seeking a new career or career change, but don’t know which job track within clinical research to pursue. The course includes an appendix of time management and interviewing tips.

Take advantage of our $1,695.00 price by registering early! * After November 4, costs are $1,895.00.

December 7-8, 2016

Clinical Project Management: Introduction to Practical Clinical Trial Planning for Project Managers
Philadelphia, PA

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. There is specific focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course includes discussion of a highly detailed and fully developed clinical trial management process map. Discussions of the process map are practically oriented with emphasis given to useful advice that, when implemented, will assist with trial management.

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 8, 2016

How to Write Great SOPs and Work Instructions
Philadelphia, PA

Standard Operating Procedures (SOPs) and Work Instructions are of high value when they are written properly. Too often authors leave out the right details to make these documents user-friendly and add-in items can cause confusion and lead to misunderstandings and at worse, non-compliance. This course presents a best practice for developing SOPs and Work Instructions starting with the critical technique of process mapping. In this seminar, learners will be taught the various components of each document and tips on how to write effective, user-friendly SOPs and Work Instructions. Participants will have an opportunity to bring a draft SOP and/or Work Instruction to the class and obtain feedback.

This is a highly practical course with real-world tips from persons in the field who create, review, and audit these documents.

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

December 8, 2016

How to Write Effective Monitoring Reports and Communications
Boston, MA

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. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring. Increasingly, we notice that the Confirmation Letters, Monitoring Visit Reports, and Follow-Up Letters have discrepancies. This may be simple date inconsistencies, or critical data credibility issues. It is important that the monitor be aware of the importance of these issues in the review of study documentation. This module will provide some practical solutions to addressing document deficiencies as well as provide a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

The monitor visit starts with a well-written Confirmation Letter informing the investigator and investigator’s staff of the expectations of the upcoming visit. An accurate and complete Monitoring Visit Report details all of the activities of the monitor in meeting the sponsor’s obligation during the actual monitor visit, including action items and demonstrable management of the site by the monitor. Queries must be well-written if they are to be understood by the study coordinator or Principal Investigator at the site. The Follow-Up Letter, which must detail the progress made on this visit and highlight any deficiencies for which the monitor expects resolution must agree with the action items listed in the Monitoring Visit Report. Written documentation of Telephone Contacts must be direct, accurate, and timely; other communications between monitor visits need to be associated with the proper events as well. This module will provide an understanding of the information required, importance of timely and well-documented discussions, and proper methods of filing this key documentation. This workshop is invaluable for the CRA as well as the individual who critiques the various reports.

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

December 13-15, 2016

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 November 11, costs are $1,895.00.

December 13, 2016

Medical Writing Fundamentals: How to Write Regulatory Documents
San Francisco, CA

This 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 seminar will give learners a broad understanding of writing practices, formatting, working with tables and figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. In addition, real-life examples of strategies for generating a great document each time by understanding the what and why of the different documents will be presented.

Take advantage of our $800.00 price by registering early! * After November 11, costs are $1,000.00.

December 13-15, 2016

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. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. 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.

Take advantage of our $1,695.00 price by registering early! * After November 11, costs are $1,895.00.

December 13-14, 2016

Working with CROs: Building a Partnership for Project Success
Philadelphia, PA

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 November 11, costs are $1,795.00.

December 14-15, 2016

Effectively Writing Clinical Trial Protocols
San Francisco, CA

The basis and success of any clinical development program is the study protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol. However, there is considerable variability between companies and individuals regarding the approach to writing this critical document, even with a good understanding of ICH guidelines. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to achieving IRB and ultimately market approval. Over the course of development, new protocols, protocol amendments, and protocol concept sheets are needed on an ongoing basis. Though they require similar information, protocols for drugs, biologics, and devices require different approaches, and may be dependent on phase of development. Moreover, amendments, however unwelcome, are a necessary part of the development process. Amendments must be managed efficiently to avoid costly implementation or delays to the ongoing trial.

Take advantage of our $1,595.00 price by registering early! * After November 11, costs are $1,795.00.

December 15-16, 2016

Strategic Clinical Research Operational Planning: Applied Techniques for Cost Estimation, Risk Management, and Quality Assurance
San Francisco, CA

This course is an integrative learning experience, combining a comprehensive review of the Good Clinical Practice core principles and project management strategies applicable to clinical research during the new drug development process. We will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), risk management, and quality assurance. We will focus on the principles and methodology of planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, developing a project plan, scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks will provide clinical research professionals a significant competitive advantage in the marketplace.

Take advantage of our $1,595.00 price by registering early! * After November 11, costs are $1,795.00.

December 19-20, 2016

Monitoring Clinical Drug Studies: Intermediate
Boston, MA

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate – with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, comonitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials and GCP principles.

Take advantage of our $1,595.00 price by registering early! * After November 18, costs are $1,795.00.

December 20-21, 2016

Advanced Post-Marketing Pharmacovigilance Auditing
San Francisco, CA

The European Medicines Agency’s (EMA) post-marketing Pharmacovigilance (PV) regulations known as the EMA PV Modules are designed with the expectation that companies adhere to this new global “gold” standard regarding the receipt, processing, managing, maintenance, and submissions of Adverse Event (AE) data to the relevant health authorities. Not only are these standards applicable to EU-based companies, but any company marketing products (drugs or devices) on a global level. We will review the FDA and EMA expectations, and apply them to the various PV audits.

This course is designed for those that already have some post-marketing PV experience (either experienced auditors or practical hands-on PV staff ). Learners will receive training on how to audit PV at the local level, but to do it with a global perspective. The course will focus on understanding PV agreements, and reporting to health authorities and the relevant auditing mechanisms, including the generation of the annual audit plan based on a risk assessment; generating audit agendas once the plans are put into play; understanding Safety Data Exchange Agreements (SDEA); understanding Periodic Safety Update Reports (PSURs); requesting pre-audit information of PV departments in-house, at a license/marketing partner, vendor, or distributor; and generating the correct categorization of findings for the audit reports.

Take advantage of our $1,595.00 price by registering early! * After November 18, costs are $1,795.00.

December 20-21, 2016

Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions
San Francisco, 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.

Submissions to a regulatory agency involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing (IND), and marketing (NDA/CTD) applications. Participants also gain experience with tools that help manage timelines and sections needed from contributors.

Take advantage of our $1,595.00 price by registering early! * After November 18, costs are $1,795.00.

January

January 24-25, 2017

Conducting Clinical Trials Under ICH GCP
San Diego, CA

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. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for the clinical studies.

Take advantage of our $1,595.00 price by registering early! * After December 23, costs are $1,795.00.

January 24, 2017

Developing Clinical Study Budgets
San Diego, CA

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 December 23, costs are $1,000.00.

January 24-25, 2017

Monitoring Clinical Drug Studies: Advanced
San Diego, CA

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 December 23, costs are $1,795.00.

January 30-31, 2017

Optimizing Protocol Design and Strategies to Achieve Efficient, Lower Cost Trial Execution
San Diego, CA

This course will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity, especially in trials that involve imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity, while at the same time ensuring trial success, will be discussed. This course will also identify pre-award processes and institutional approaches to increasing fiscal return and mitigating fiscal compliance risk for clinical trials. The ability to develop comprehensive budgets and ensure billing compliance for clinical trials is challenging for many clinical sites. Poor financial planning/forecasting and undefined billing compliance practices are associated with increased risk leading to deficits and Office of Inspector General (OIG) investigations. Strategies for covering true costs related to protocol design and multi-disciplinary approaches will be discussed.

Take advantage of our $1,595.00 price by registering early! * After December 23, costs are $1,795.00.

January 31 - February 1, 2017

Clinical Project Management Advanced
Boston, MA

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. retention.

Take advantage of our $1,595.00 price by registering early! * After December 29, costs are $1,795.00.

February

February 1-2, 2017

Adverse Events: Managing and Reporting for Medical Devices
Philadelphia, PA

This course provides a detailed and thorough introduction of FDA regulations for newcomers in the field of medical device safety: a comprehensive overview of the requirements, current approaches for professionals in the research and post-marketing areas, an overview of the emerging field of devices that deliver drugs or biologics, and an opportunity to discuss the challenges facing those reporting and managing adverse events in the medical device industry.

Take advantage of our $1,595.00 price by registering early! * After December 29, costs are $1,795.00.

February 1-2, 2017

Working with CROs: Building a Partnership for Project Success
Philadelphia, PA

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 December 29, costs are $1,795.00.

February 3, 2017

Developing Effective Training and Facilitation Skills in Clinical Research: An Application-Based Course
Philadelphia, PA

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. If our goal in training is to pass on knowledge and to ask learners to apply that information, we need to consider our approach in how to make this happen. It is important to consider how essential every teleconference, meeting, and conversation is within research; the information shared can have a huge impact on study timelines, data integrity, and compliance. If information is not internalized by the learner, then the time spent discussing it is a waste and the consequences may be significant.

In this course, training and facilitation methodology, skills, and fundamentals will be applied in a highly interactive and engaging day of activities. Learning styles and approaches will be explored with a focus on how we can apply this to our daily tasks in clinical research. This course focuses on the practical application and tools needed to ensure that an audience is able to remember and apply the information shared. Learners will have time to work in groups in developing activities, creating course plans, and practicing skills. An emphasis of the course will be to change the way we approach instruction in order to best facilitate learning and the transfer and ownership of the information.

Take advantage of our $800.00 price by registering early! * After December 29, costs are $1,000.00.

February 6-8, 2017

Monitoring Clinical Drug Studies: Beginner
Philadelphia, PA

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 January 6, costs are $1,895.00.

February 7-8, 2017

Auditing Techniques for Clinical Research Professionals
Boston, MA

This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of quality systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

Take advantage of our $1,595.00 price by registering early! * After January 6, costs are $1,795.00.

February 7-9, 2017

Comprehensive Monitoring for Medical Devices
Philadelphia, PA

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 January 6, costs are $1,895.00.

February 7-8, 2017

Soft Skills Development for Clinical Research Professionals
Boston, MA

In an environment that is ever-changing with organizational mergers, role revisions, and an emphasis on risk-based oversight approaches, the need for better communication skills and comfort with change is essential. The focus of this course is to enhance communication skills and support personal development while building stronger team relationships in clinical research settings. This course is designed to demonstrate and reinforce techniques such as prioritization, greater effectiveness, flexibility to support work-life balance, communication, and focusing on becoming leaders in our individual areas. Self-evaluation and consideration of “why” we react to things the way we do and how we can implement change will be addressed through various activities. These skills are valuable in addressing many of the everyday stresses faced by those in the clinical research industry.

Take advantage of our $1,595.00 price by registering early! * After January 6, costs are $1,795.00.

February 13-15, 2017

CRA & CRC Beginner Program
Boston, MA

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC.

Take advantage of our $1,695.00 price by registering early! * After January 30, costs are $1,895.00.

February 21-22, 2017

Adverse Events: Managing and Reporting for Pharmaceuticals
San Diego, CA

This course provides an excellent introduction for newcomers to the field of drug and biologic product AE reporting, a comprehensive overview of current approaches and regulations for professionals in the field, and challenging questions and ideas for the experienced clinical research professional. This course contains medical device content related only to use in combination products.

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 21-22, 2017

Medical Device Approval Process: Preparation and Processing of 510(k)s, IDEs, and PMAs
San Diego, CA

This course highlights new changes to medical device regulations and provides an overview to the submission of documents to the FDA for approval of medical device products. Participants gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to provide the FDA with necessary information and obtain product approval.

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 21-22, 2017

Monitoring Clinical Drug Studies: Intermediate
Philadelphia, PA

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate – with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, comonitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials and GCP principles.

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 21-22, 2017

Strategic Clinical Research Operational Planning: Applied Techniques for Cost Estimation, Risk Management, and Quality Assurance
San Diego, CA

This course is an integrative learning experience, combining a comprehensive review of the Good Clinical Practice core principles and project management strategies applicable to clinical research during the new drug development process. We will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), risk management, and quality assurance. We will focus on the principles and methodology of planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, developing a project plan, scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks will provide clinical research professionals a significant competitive advantage in the marketplace.

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 21-22, 2017

The CRA Manager Course
San Diego, CA

The focus of this course is to strengthen the skills required of the CRA Manager to effectively manage,motivate, and optimize the performance of CRA teams. In this course, you will sharpen your people skills and develop an understanding of the key components of successful team and performance management. This course is a must for new and aspiring managers. Several document templates will be provided for you to customize and use during your daily activities as a Manager. Examples and interactive exercises will pertain specifically to managing Clinical Research Associates (CRAs).

Take advantage of our $1,595.00 price by registering early! * After January 20, costs are $1,795.00.

February 21-22, 2017

Complying with Quality System (QS) Regulation Requirements and Exceeding Expectations: One-Day Primer for Medical Device Manufactures
San Diego, CA

The process of assuring FDA compliance to quality system requirements is different for every company, depending on company size, operations, and priorities. Current good manufacturing practice (cGMP) requirements are set forth in FDA’s Quality System (QS) regulation. The requirements in the QS regulation and in 21 CFR 820 govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements are intended to ensure that finished medical devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. The QS regulation establishes basic requirements applicable to manufacturers of finished medical devices.

In the QS regulation, FDA has identified the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements, and to develop and implement specific procedures tailored to their particular processes and devices.

This interactive course will provide guidance and direction that will allow you to develop strategies, add business value, and minimize delays by providing strategic/tactical solutions that facilitate the achievement of regulatory and quality milestones.

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 21-22, 2017

The Future of Clinical Trial Conduct Demands a Quality System Approach: Will You be Ready?
San Diego, CA

The future of clinical trial conduct demands a Quality System approach. Recently, regulators have been recommending that a quality system approach be used for the design, development, and execution of clinical studies. Newly released FDA guidances speak on the need to conduct clinical trials using such an approach, but provide little in the way of direction on how to accomplish this. Risk management is an integral component of a quality system approach, and many researchers do not have the knowledge or experience to conduct clinical trial risk management. This course will apply practical approaches and demonstrate associated tools and skills to assist the participant in using a quality system approach within the clinical trial arena from both the site and sponsor perspective.

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 21-22, 2017

The Highly Effective CRA: Soft Skills for Taking Your Work to the Next Level
San Diego, CA

Good monitoring skills are not the only critical skills a CRA needs to be effective in their role. A highly effective CRA is a great communicator; focuses on building relationships and partnership with their key stakeholders to position their projects/studies for success; resolves conflict with confidence, bravery, and laser-sharp solution focus; is able to anticipate potential challenges and barriers to success and takes the steps to remove and/or mitigate them; and identifies and solves problems.

This course is for the CRA who wants to build upon their existing communication, problem solving, and conflict resolution skills, and ultimately increase their effectiveness at the study site. Through highly interactive role-play and real-world case study activities, we will address:

  • How do I drive results when I do not have direct authority over the investigator?
  • How do I have the tough conversations with the investigator and her/his staff?
  • How can I move from reacting to challenges to anticipating and removing barriers to success?
  • How do I take my work to the next level of effectiveness?

Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.

February 22-23, 2017

Good Clinical Practice Regulatory Changes, Trends, and Best Practices Implementation
San Diego, CA

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 January 20, costs are $1,795.00.

February 23, 2017

How to Write Great SOPs and Work Instructions
San Diego, CA

Standard Operating Procedures (SOPs) and Work Instructions are of high value when they are written properly. Too often authors leave out the right details to make these documents user-friendly and add-in items can cause confusion and lead to misunderstandings and at worse, non-compliance. This course presents a best practice for developing SOPs and Work Instructions starting with the critical technique of process mapping. In this seminar, learners will be taught the various components of each document and tips on how to write effective, user-friendly SOPs and Work Instructions. Participants will have an opportunity to bring a draft SOP and/or Work Instruction to the class and obtain feedback.

This is a highly practical course with real-world tips from persons in the field who create, review, and audit these documents.

Take advantage of our $800.00 price by registering early! * After January 20, costs are $1,000.00.

March

March 1, 2017

Becoming a Clinical Research Investigator: Expectations and Responsibilities
Philadelphia, PA

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 January 27, costs are $1,000.00.

March 1-2, 2017

Pharmacokinetics: A Comprehensive Overview of Principles and Applications
Philadelphia, PA

The course will provide participants with a comprehensive overview of pharmacokinetics by integrating concepts in physiology and mathematics. At the end of this seminar, attendees will understand fundamental pharmacokinetic concepts and be able to use them to design pharmacokinetic studies, compute pharmacokinetic parameters, and predict the effect of physiological and formulation changes on the pharmacokinetics of drugs. The instructor will provide an overview of the anatomy and physiology of organ systems relevant to drug absorption, distribution, metabolism, and excretion, explain pharmacokinetic concepts, demonstrate computation of pharmacokinetic parameters after intravenous and oral doses, and highlight concepts in bioavailability, bioequivalence, and biopharmaceutics. Understanding of theoretical principles will be facilitated by numerous practical examples from the literature, and through case studies. Periodic review and reinforcement of important concepts will be achieved through discussions, and completion of a series of in-class assignments.

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

March 2-3, 2017

Medical Device GCP Overview
Philadelphia, PA

This course provides information across the full range of medical device clinical trial activities; and applicable Good Clinical Practices (FDA 21 CFR 812 Investigational Device Exemption, ISO 14155 Clinical Investigations of Medical Devices, and principles of ICH Good Clinical Practices E6 Guideline). It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.

Take advantage of our $1,595.00 price by registering early! * After January 27, costs are $1,795.00.

March 7-8, 2017

Adverse Events: Managing and Reporting for Pharmaceuticals
Philadelphia, PA

This course provides an excellent introduction for newcomers to the field of drug and biologic product AE reporting, a comprehensive overview of current approaches and regulations for professionals in the field, and challenging questions and ideas for the experienced clinical research professional. This course contains medical device content related only to use in combination products.

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

March 7-8, 2017

Clinical Project Management: Intermediate
Philadelphia, PA

The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

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

March 7-8, 2017

Developing CRAs as Site Study Managers
San Diego, CA

The person that has the most contact with the site is the Clinical Research Associate (CRA); they are the “face” of the sponsor, the purveyor of information, and the person that most influences the site’s performance on a study. In a sense, CRAs are the sponsor’s On-Site Study Managers. It is critical that this individual be in a position to positively reflect the sponsor and ensure the site performs to their full potential through training, knowledge, and support. CRAs must understand the data review process, but they must also havethe skills to train, mentor, and communicate with new and experienced site staff, and to navigate the path through challenging situations. In addition, the CRA needs to be equipped and prepared to communicate with the Principal Investigator (PI) and be able to support the site in recruitment efforts and the documentation process. A better understanding of adult learning techniques, unique and thorough approaches to recruitment and retention strategies, carefully developed and implemented communication plans, and an understanding of project management techniques can make the difference between a site meeting enrollment with minimal deviations, and a site lacking in enrollment with multiple protocol violations. This course will focus on a variety of techniques and training to help CRAs move from monitors to on-site study managers in their skills.

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

March 7-8, 2017

Effectively Writing Clinical Trial Protocols
San Diego, CA

The basis and success of any clinical development program is the study protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol. However, there is considerable variability between companies and individuals regarding the approach to writing this critical document, even with a good understanding of ICH guidelines. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to achieving IRB and ultimately market approval. Over the course of development, new protocols, protocol amendments, and protocol concept sheets are needed on an ongoing basis. Though they require similar information, protocols for drugs, biologics, and devices require different approaches, and may be dependent on phase of development. Moreover, amendments, however unwelcome, are a necessary part of the development process. Amendments must be managed efficiently to avoid costly implementation or delays to the ongoing trial.

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

March 7-8, 2017

Writing Clinical Evaluation Reports
San Diego, CA

This course will include a review of the Medical Devices (MEDDEV) 2.7.1, Rev 4 guideline issued in June 2016 and a discussion of the Therapeutic Goods Administration (TGA) guideline. In this interactive program, participants will also have the opportunity to share their experiences with Clinical Evaluation Reports (CERs) in general. All devices are required to have a CER for products marketed in the EU and globally. This course will explore good writing skills and techniques needed to create a CER and to respond to reviewer comments.

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

March 9, 2017

Medical Writing Fundamentals: How to Write Regulatory Documents
San Diego, CA

This 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 seminar will give learners a broad understanding of writing practices, formatting, working with tables and figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. In addition, real-life examples of strategies for generating a great document each time by understanding the what and why of the different documents will be presented.

Take advantage of our $800.00 price by registering early! * After February 6, costs are $1,000.00.

March 9, 2017

Risk-Based Monitoring: Successful Planning and Implementation
San Diego, CA

A fundamental shift is occurring in the clinical research industry related to how sponsors satisfy their regulatory and GCP requirements for the adequate monitoring of clinical trials. Recent regulatory authority guidance and industry initiatives are both promoting a modern approach to clinical trial monitoring based upon program and study-specific risk assessments and mitigation plans. In order for clinical research professionals to embrace this industry shift, it is critical that they understand the rationale, concepts, and actual work practices inherent in risk-based monitoring.

This course is designed for clinical research professionals across the spectrum of research organizations, investigational product types, and experience levels. Participants will acquire a deeper understanding of the philosophy of risk-based monitoring and be able to apply this understanding to operational activities including the following:

  • Performing program and study-level risk assessments and managing risks
  • Writing a risk-based Monitoring Plan
  • Designing reports and metrics for central monitoring activities
  • Supporting Clinical Research Associates for success in the new monitoring environment
  • Preparing Investigators and site personnel for risk-based monitoring

Take advantage of our $800.00 price by registering early! * After February 6, costs are $1,000.00.

March 14-15, 2017

Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
Philadelphia, PA

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. The corrective action process including, when appropriate, preventive action planning, should be implemented when RCA has been completed. An effective CAPA process can lead to improved human subject protections and confidence in the integrity of the data. Lack of effective corrective action management can lead to repeated non-compliance, compromised subject safety, poor data quality, and/ or unacceptable inspection findings with subsequent negative impact on the final submission. This course focuses specifically on the management of noncompliance issues occurring at investigative sites.

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

March 21-22, 2017

Clinical Project Management: Introduction to Practical Clinical Trial Planning for Project Managers
San Diego, CA

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. There is specific focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course includes discussion of a highly detailed and fully developed clinical trial management process map. Discussions of the process map are practically oriented with emphasis given to useful advice that, when implemented, will assist with trial management.

Take advantage of our $1,595.00 price by registering early! * After February 17, costs are $1,795.00.