CenterWatch

Training Programs

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

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.

March 28-29, 2017

Clinical Project Management: Intermediate
San Diego, CA

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 24, costs are $1,795.00.

March 28, 2017

Detecting Risk Signals in Protocols, Data, and Monitoring
San Francisco, CA

In an environment where remote monitoring and management techniques are becoming the daily practice, preventative measures need to be implemented to identify risks. You need to be able to identify protocol data thresholds and parameters for risks to establish management and escalation triggers. As data becomes available in real time, you should not be waiting until deviations become a “trend” before intervention is implemented; we need to know how to look for outliers and “red flags” on a daily basis. With increasing use of CROs and vendors, it is essential that best practices are established for identifying risk signals in management and monitoring practices. This course will discuss how to detect risk signals in protocols, data, and monitoring based on risk-based quality management, industry guidances, and practical application. This one day course will include hands-on activities centered around identifying and implementing preventative measures in a sample protocol, communication and management techniques, and plan development.

Take advantage of our $800.00 price by registering early! * After February 24, costs are $1,000.00.

March 28-29, 2017

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance
San Francisco, CA

This course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across US and EU agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet US and EU safety reporting standards.

Take advantage of our $1,595.00 price by registering early! * After February 24, costs are $1,795.00.

March 28-29, 2017

Introduction to FDA
Philadelphia, PA

This course provides an introduction to the Food and Drug Administration (FDA) to those who need to have an understanding of FDA to perform their jobs. The course provides a background on the agency, FDA history, FDA organization and a look at how FDA functions divisionally.

Those attending will learn about the various FDA centers and what the center responsibilities are. The attendee will also learn about the FDA review process, FDA submissions, Advisory Committees, FDA clinical trials and FDA compliance activities.

Take advantage of our $1,595.00 price by registering early! * After February 24, costs are $1,795.00.

March 28-29, 2017

Practical Problem Solving for Clinical Research Professionals
San Francisco, CA

Twenty-first century leaders are problem solvers. But how do successful leaders get from point A: Identifying a problem exists to point B: The problem is solved? The answer is: Very carefully, especially when they don’t have authority over budget. This highly interactive, practical course presents participants with best practice methodologies and key tools and techniques to help them take a problem from root cause analysis, to creating a cost-benefit analysis, to crafting a compelling story in an effort to obtain funding. Participants will have the opportunity to work on their own work-related problem during several activities. Participants will leave with a partially completed business case for their solution as well as the benefit of hearing first-hand accounts of practical solutions from other participants.

Take advantage of our $1,595.00 price by registering early! * After February 24, costs are $1,795.00.

March 28, 2017

Trial Master Files: Why They Are Important and How to Organize Them
San Francisco, CA

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND. The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP E6, Section 8.1 defines these Essential Documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. They are all also eligible for inspection by the regulatory authorities at any time during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics and devices. It is, therefore, paramount that these documents are filed in a way to make them immediately accessible for use by the study team and for regulatory inspection. This module will provide some practical solutions to meet these challenges.

Participants will review the content that is required of a Trial Master File for drugs and devices for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

The activities of set-up, maintenance, and quality assurance will be discussed, as well as common deficiencies and challenges. The need for an effective Standard Operating Procedure (SOP) will also be examined.

In today’s regulatory environment, the files must be “audit ready” at all times. Regulatory authorities may contact the sponsor and request a particular document be provided to them for inspection. Therefore, the timely filing and organization of these documents is of utmost importance. There needs to be a consistent system employed such that documents can be located and provided for study team use as well as regulatory inspection in a timely manner.

Take advantage of our $800.00 price by registering early! * After February 24, costs are $1,000.00.

March 29, 2017

Investigator-Initiated Trials (IITs) and the Role and Responsibilities of the Investigator
San Francisco, CA

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 February 24, costs are $1,000.00.

March 29, 2017

Case Report Form Design, Strategy, and Standards
San Francisco, CA

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

Other regulations, such as the ICH GCP E6 guidelines, identify the Case Report Form (CRF) as one of the essential documents for a clinical trial. Therefore, it is imperative to understand and implement the best practices of the CRF design process. That includes making sure all the protocol-required data are collected, ensuring the design of the CRF minimizes errors, and keeping the study coordinator in their normal workflow.

It is also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that data collection is consistent, concise, and compatible, hence, the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.

This workshop will discuss the principles of good CRF design, the timing of CRF design in relation to clinical trial start-up, and the team that will contribute to the data collection recommendations. Participants will review a sample protocol and determine which CRFs will be required to collect the appropriate data. We will discuss design philosophies and rationales and apply these principles in reviewing CRFs to critique design. We will also discuss the resources that are utilized in determining what data collection is required and the current standards for CRF data content.

The module based on best practices for CRF design as documented in the SCDM GCDMP will provide the understanding of the expectations for purposeful CRF design.

Note: This workshop will deal with the principles and fundamentals relating to data elements for good CRF design. It is not intended as a training in a software application to create the CRF.

Take advantage of our $800.00 price by registering early! * After February 24, costs are $1,000.00.

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.