CenterWatch

Training Programs

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

October

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

www.phleb.com/privategroups.html

October 4, 2016

Avoiding Deficiencies in Clinical Evaluation Reports for Medical Devices
Philadelphia, PA

This seminar will address the details and challenges of writing a Clinical Evaluation Report (CER). Learn what constitutes a CER and how to ensure your CER meets the requirements outlined in MedDev 2.7.1. CERs are required in the EU to document the safety and performance of a medical device by analyzing three broad types of clinical data including clinical trial information (where the company fully analyzes the clinical trial data for the specific device in question), clinical literature (including both published and unpublished reports about the device), and clinical use information (including reports from users of the device, for example, complaints or post-market vigilance data about the device). In this seminar, you will learn about the different parts of a CER and what information should be analyzed for each, including clinical trials, clinical literature, and clinical experience. Finally, we will discuss the importance of using the CER as part of a product lifecycle, and tying this document in to your current risk management strategy to improve the overall benefit:risk analysis of your device.

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

October 4-5, 2016

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

This course is an introduction to clinical project management in the pharmaceutical industry. The focus is on individuals who want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials. The needs of relatively new project managers who are not familiar, or experienced, with specific technical tasks involved in clinical trial management are addressed. 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 September 1, costs are $1,795.00.

October 4-5, 2016

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 September 1, costs are $1,795.00.

October 4, 2016

Patient Recruitment and Retention: Successful Planning and Management
Philadelphia, PA

What does it take to successfully plan and implement a successful patient recruitment and retention program be it at the local site level or study-wide level? What’s the difference between recruitment sources, strategies and tactics? What are the elements that fundamentally influence or determine a patient’s participation in the trial? When and how should recruitment planning discussions take place vis-à-vis the study feasibility assessment process? What’s the link between site engagement and successful patient recruitment and retention? If you are interested in exploring the answers to these and other questions, then this seminar is for you. Going beyond a discussion of advertising and outreach tactics, this course will systematically evaluate both theoretical as well as practical aspects of all of the factors necessary for an effective patient recruitment and retention program.

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

October 4-5, 2016

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 September 1, costs are $1,795.00.

October 4-5, 2016

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 September 1, costs are $1,795.00.

October 6, 2016

Trial Master Files: Why They Are Important and How to Organize Them
Boston, MA

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, 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.

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

October 11-12, 2016

Auditing Techniques for Clinical Research Professionals
San Francisco, CA

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 September 9, costs are $1,795.00.

October 11-13, 2016

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. 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 September 9, costs are $1,895.00.

October 11-12, 2016

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

Take advantage of our $1,595.00 price by registering early! * After September 9, costs are $1,795.00.

October 13-14, 2016

Adverse Events: Managing and Reporting for Pharmaceuticals
San Francisco, 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 September 12, costs are $1,795.00.

October 13, 2016

How to Write Great SOPs and Work Instructions
San Francisco, 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.

Take advantage of our $800.00 price by registering early! * After September 12, costs are $1,000.00.

October 13-14, 2016

Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions
Philadelphia, PA

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.

Take advantage of our $1,595.00 price by registering early! * After September 12, costs are $1,795.00.

October 13-14, 2016

The Future of Clinical Trial Conduct Demands a Quality System Approach: Will You be Ready?
Philadelphia, PA

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 July 15, costs are $1,795.00.

October 14, 2016

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.”

Take advantage of our $800.00 price by registering early! * After September 12, costs are $1,000.00.

October 17-18, 2016

Advanced Good Clinical Practice: Practical Application and Implementation
Philadelphia, PA

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

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

October 17-18, 2016

Statistical Concepts for Non-Statisticians
Boston, MA

Designed for non-statisticians, this basic statistical concepts workshop has direct applicability to clinical research. The choice of statistical method, the application of statistical principles, and the interpretation of statistical results are the foundation of the design and analysis of clinical trials. It is therefore critical that statistical methods are fully understood before they are implemented. This course is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Please note that this is not a course on statistical formulas or computations.

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

October 18-20, 2016

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. 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 September 16, costs are $1,895.00.

October 20-21, 2016

Drug Approval Process: Preparation and Processing of INDs and NDAs
Boston, MA

This course provides a comprehensive approach to the preparation and submission of documents to the FDA for approval of drug products. Participants receive a foundation of knowledge about the drug approval process, submission preparation, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and assembly of INDs, NDAs, and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to prepare concise documents, provide the FDA with necessary information, and obtain rapid product approval.

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

October 20-21, 2016

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 September 19, costs are $1,795.00.

October 25-27, 2016

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 September 23, costs are $1,895.00.

October 25-26, 2016

Developing CRAs as Site Study Managers
Philadelphia, PA

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 September 23, costs are $1,795.00.

October 25-26, 2016

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

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

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. The concepts covered are invaluable for all stakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC.

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

October 27, 2016

Developing Clinical Study Budgets
Philadelphia, PA

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

Take advantage of our $800.00 price by registering early! * After September 23, costs are $1,000.00.

November

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

www.phleb.com/privategroups.html

November 1-2, 2016

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 September 30, costs are $1,795.00.

November 1-2, 2016

Introduction to Clinical Research
San Diego, CA

This two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable. Then we will look at the process of drug and device development from discovery to approval. We will introduce you to the protocol which is the blue print for any clinical trial and explain what an informed consent is and why it is so important. In addition to these key trial documents, we will also review other important documents that are used in clinical trials. Finally, we will provide you with resources that will enable you to stay informed about topics and regulations regarding clinical trials in the U.S. and in the European Union.

Take advantage of our $1,595.00 price by registering early! * After September 30, costs are $1,795.00.

November 2, 2016

Becoming a Preferred Site: Quality and Documentation Tips for Compliance
San Diego, CA

What is a preferred site? How does one assess feasibility to determine if a study is a good fit for your site/sponsor? What can a site do to ensure a clinical trial is feasible? First impressions count, but best practices must be continued throughout the life of the trial to ensure preferred status. This workshop will explore best practices for FDA-compliant source and regulatory documentation and the tools that can help to get you there. Most non-compliance noted through monitor visits, regulatory inspections, and audits stem from inadequate and inconsistent documentation at sites. Learn how to best prepare for a monitoring visit or site audit/inspection. Learn techniques to better manage your regulatory files and prepare to answer sponsors, auditors, and inspectors regarding screening/enrollment numbers, subject withdrawal, informed consent, recruitment efforts, delegation of authority, protocol violations, and adverse events. Identify what is adequate source. What do I really need to file in my site master file, what are “extras” that will make my site preferred by sponsors? Evaluate how to best document PI oversight. Determine when to use a note-to-file and what constitutes an effective CAPA. Tips and tricks for managing the regulatory file will be provided through tools/worksheets/templates and interactive activities.

Take advantage of our $800.00 price by registering early! * After September 30, costs are $1,000.00.

November 2, 2016

How to Write Effective Monitoring Reports and Communications
San Diego, CA

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 September 30, costs are $1,000.00.

November 3, 2016

Investigator-Initiated Trials (IITs) and the Role and Responsibilities of the Investigator
San Diego, 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 October 3, costs are $1,000.00.

November 3, 2016

Trial Master Files: Why They Are Important and How to Organize Them
San Diego, 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, 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 October 3, costs are $1,000.00.

November 8-9, 2016

Monitoring Clinical Drug Studies: Advanced
San Francisco, 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 October 7, costs are $1,795.00.

November 8-9, 2016

Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
San Francisco, CA

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. The concepts covered are invaluable for all stakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC.

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

November 8-9, 2016

The CRA Manager Course
Boston, MA

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 October 7, costs are $1,795.00.

November 10, 2016

Drug Development and FDA Regulations
Boston, MA

This course provides an overview of the drug development process including GLP, GCP, and GMP processes. It is ideal for early stage investigators from varied disciplines and new industry professionals with a need to develop an understanding of the drug development process. The course will review the steps that lead up to the clinical trial process. It will discuss the phases of clinical development that are part of the IND (the actual human trials that are conducted to demonstrate safety and efficacy to allow the regulatory authorities reason to approve the investigational drug for marketing). The NDA process will then be reviewed with insight into possible post-NDA activities that may be requested. The included workbook is a great tool for reference purposes.

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

November 15-16, 2016

Clinical Project Management Advanced
Philadelphia, PA

This course provides the experienced project manager the additional skills they need to lead their domestic and international clinical trials to optimal performance. This two-day course builds upon basic and intermediate project management concepts, 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 October 14, costs are $1,795.00.

November 16-17, 2016

Basics of Post-Marketing Pharmacovigilance and the Beginner PV Auditor
Philadelphia, PA

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 October 14, costs are $1,795.00.

November 16-17, 2016

Medical Device Approval Process: Preparation and Processing of 510(k)s, IDEs, and PMAs
Philadelphia, PA

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 October 14, costs are $1,795.00.

November 30 - December 1, 2016

Clinical Project Management: Intermediate
San Francisco, 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 October 31, costs are $1,795.00.

December

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

www.phleb.com/privategroups.html

December 1-2, 2016

Auditing Techniques for Clinical Research Professionals
Philadelphia, PA

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 October 31, costs are $1,795.00.

December 1-2, 2016

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance
Boston, MA

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 October 31, costs are $1,795.00.

December 1, 2016

Patient Recruitment and Retention: Successful Planning and Management
San Francisco, CA

What does it take to successfully plan and implement a successful patient recruitment and retention program be it at the local site level or study-wide level? What’s the difference between recruitment sources, strategies and tactics? What are the elements that fundamentally influence or determine a patient’s participation in the trial? When and how should recruitment planning discussions take place vis-à-vis the study feasibility assessment process? What’s the link between site engagement and successful patient recruitment and retention? If you are interested in exploring the answers to these and other questions, then this seminar is for you. Going beyond a discussion of advertising and outreach tactics, this course will systematically evaluate both theoretical as well as practical aspects of all of the factors necessary for an effective patient recruitment and retention program.

Take advantage of our $800.00 price by registering early! * After October 31, costs are $1,000.00.

December 2, 2016

Informed Consent - Beyond the Basics
San Francisco, CA

This intensive course provides a detailed exploration of best practices surrounding the development of informed consent and patient educational materials as well as tools and methodologies for obtaining informed consent. Going beyond the minimum regulatory requirements, this course offers practical as well as theoretical information for enhancing the informed consent process.

Take advantage of our $800.00 price by registering early! * After October 31, costs are $1,000.00.

December 5-6, 2016

Advanced Good Clinical Practice: Practical Application and Implementation
Boston, MA

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

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

December 6-7, 2016

Adverse Events: Managing and Reporting for Medical Devices
Boston, MA

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 November 4, costs are $1,795.00.

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 6-7, 2016

Developing CRAs as Site Study Managers
San Francisco, 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 November 4, costs are $1,795.00.

December 6-7, 2016

Medical Device GCP Overview
Boston, MA

This course provides information across the full range of medical device clinical trial activities. 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 November 4, costs are $1,795.00.

December 6-7, 2016

Monitoring Oncology Clinical Trials
San Francisco, CA

This course is designed for Clinical Research Associates (CRAs) currently working in the industry who are interested in gaining knowledge about monitoring in the oncology therapeutic area. As the demand for CRAs in the oncology arena continues to grow, this course offers practical, hands-on training covering oncology-specific logistical, clinical, and ethical considerations. The application of clinical monitoring skills to oncology trials is reinforced through interactive discussions, case studies, and practice-based activities. The course content is also valuable to Project Managers and CRA Managers working in the oncology field as they seek to design feasible protocols, clinical monitoring plans, and monitoring tools adaptable to the unique requirements of these study sites and trials.

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

December 6-7, 2016

Statistical Concepts for Non-Statisticians
San Francisco, CA

Designed for non-statisticians, this basic statistical concepts workshop has direct applicability to clinical research. The choice of statistical method, the application of statistical principles, and the interpretation of statistical results are the foundation of the design and analysis of clinical trials. It is therefore critical that statistical methods are fully understood before they are implemented. This course is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Please note that this is not a course on statistical formulas or computations.

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

December 6-7, 2016

The Highly Effective CRA: Soft Skills for Taking Your Work to the Next Level
Philadelphia, PA

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 November 4, costs are $1,795.00.