CenterWatch

Training Programs

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

February

February 4, 2016

Best Practices for Writing 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the clinical trial data for the specific device in question), clinical literature (including both published and unpublished reports about the device), and clinical use information (including reports from users of the device, for example, complaints or post-market vigilance data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).

Take advantage of our $800.00 price by registering early! After January 4, costs are $1,000.00

February 4, 2016

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.

Take advantage of our $800.00 price by registering early! After January 4, costs are $1,000.00

February 9-10, 2016

Clinical Project Management Advanced
Boston, MA

This course provides attendees with the skills they need to lead their domestic and global clinical trials to optimal performance. Building on basic and intermediate project management concepts, this course provides the experienced clinical professional with tactical information to overcome the most difficult issues encountered. Advanced concepts will be presented, including performance and time management, delay tracking and prevention, ensuring adequate regional patient supply and enrollment interest before beginning a trial, strategies when enrollment is not progressing, and ensuring high quality data on a global scale.

Take advantage of our $1,595.00 price by registering early! After January 8, costs are $1,795.00

February 9-11, 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 January 8, costs are $1,895.00

February 17-18, 2016

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 $1,695.00 price by registering early! After January 8, costs are $1,895.00

February 17-19, 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 January 15, costs are $1,895.00

February 17-18, 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 January 15, costs are $1,795.00

February 22-23, 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 January 22, costs are $1,795.00

February 23-24, 2016

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 22, costs are $1,795.00

February 23-24, 2016

Inspection Readiness: Demystifying the FDA Inspection Process
San Diego, CA

There is often fear and a mystique surrounding the process of an FDA site inspection. This workshop will include insights from a former FDA medical officer on the importance of Good Clinical Practices (GCPs) to help ensure sites are prepared for the FDA. Your instructor will show learners exactly what the FDA is looking for during a site inspection, and why these inspections are critical to both the drug/device approval process. This workshop will include presentations, discussions, and problem-solving using case studies applicable to both drug and device studies. Exercises are designed to prepare you for the FDA’s arrival, anticipate FDA issues and concerns, and ensure success. Learners are encouraged to bring their questions and join in interactive discussions. Together we will de-mystify the process of FDA audits and help you learn how to ready your site for the FDA.

Take advantage of our $1,595.00 price by registering early! After January 22, costs are $1,795.00

February 23-24, 2016

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 22, costs are $1,795.00

February 23-24, 2016

Quality Systems in Clinical Research
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 22, costs are $1,795.00

February 23-24, 2016

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.

Take advantage of our $1,595.00 price by registering early! After January 22, costs are $1,795.00

February 25-26, 2016

Becoming a Preferred Site: Quality and Documentation Tips for Compliance
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.

Take advantage of our $1,595.00 price by registering early! After January 22, costs are $1,795.00

February 25-26, 2016

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 22, costs are $1,795.00

March

March 1, 2016

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.

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

March 1, 2016

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 $800.00 price by registering early! After January 29, costs are $1,000.00

March 1-2, 2016

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.

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

March 1, 2016

How to Write Effective Monitoring Reports and Communications
Philadelphia, PA

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

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

March 2-3, 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 February 1, costs are $1,795.00

March 3, 2016

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 2, costs are $1,000.00

March 3, 2016

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.

Take advantage of our $800.00 price by registering early! After February 2, costs are $1,000.00

March 8-9, 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 February 5, costs are $1,795.00

March 8-9, 2016

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 5, costs are $1,795.00

March 8, 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.

Take advantage of our $800.00 price by registering early! After February 5, costs are $1,000.00

March 9, 2016

Detecting Risk Signals in Protocols, Data, and Monitoring
San Diego, 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 5, costs are $1,000.00

March 9, 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.

Take advantage of our $800.00 price by registering early! After February 5, costs are $1,000.00

March 10, 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 February 9, costs are $1,000.00

March 15-16, 2016

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 12, costs are $1,795.00

March 22-23, 2016

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 19, costs are $1,795.00

March 22, 2016

Effective Recruitment Planning and Management for Sponsors and CROs
San Francisco, CA

With some 80-90% of clinical trials failing to meet their enrollment timelines, developing a proactive and effective patient recruitment plan is an essential requirement for any clinical trial. This course is targeted for sponsor and CRO personnel who are eager to learn more about how to establish and manage a patient recruitment plan that can ensure on-time enrollment performance. This course will focus on proven recruitment planning, management, and troubleshooting techniques. This intensive one-day interactive course is not about recruitment tactics (although we will discuss how to determine if and when study awareness activities are needed to help drive patients to the sites from external sources), but how to think strategically about all of the factors contributing to successful recruitment.

Take advantage of our $800.00 price by registering early! After February 19, costs are $1,000.00

March 22-23, 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.

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

March 22-23, 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 February 19, costs are $1,795.00

March 22-23, 2016

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.

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

March 22, 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 February 19, costs are $1,000.00

March 23, 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 February 19, costs are $1,000.00

April

April 5-6, 2016

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 March 4, costs are $1,795.00

April 5-6, 2016

Monitoring Clinical Drug Studies: Intermediate
Boston, MA

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

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

April 11-12, 2016

Planning and Conducting Global Clinical Trials
Philadelphia, PA

Increased competition for clinical trial subjects and resources has spread investigational sites and vendors all over the world. This globalization of clinical trials has helped sponsors to control drug development costs and timelines, but at the same time has generated new challenges for sponsors. This course provides a comprehensive overview of the considerations for planning and conducting trials outside the United States. Expectations of the FDA, EMA, and MHLW for trials conducted outside their regions are reviewed. Strategies for meeting these expectations in the context of differences in clinical research experience, patient populations, medical practice, language, culture, legal and regulatory requirements, logistics, and technological capacity are discussed. The course includes specific operational strategies for clinical trial implementation in both developed and developing countries.

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

April 13, 2016

Comprehensive CRC Training
Philadelphia, PA

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 $800.00 price by registering early! After March 11, costs are $1,000.00

April 18-19, 2016

Statistical Concepts for Non-Statisticians
Philadelphia, PA

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 March 18, costs are $1,795.00

April 26-27, 2016

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.

Take advantage of our $1,595.00 price by registering early! After March 25, costs are $1,795.00

April 26-27, 2016

Clinical Project Management Advanced
Boston, MA

This course provides attendees with the skills they need to lead their domestic and global clinical trials to optimal performance. Building on basic and intermediate project management concepts, this course provides the experienced clinical professional with tactical information to overcome the most difficult issues encountered. Advanced concepts will be presented, including performance and time management, delay tracking and prevention, ensuring adequate regional patient supply and enrollment interest before beginning a trial, strategies when enrollment is not progressing, and ensuring high quality data on a global scale. Advanced concepts around root cause analysis and corrective and preventive action are also presented. It is likely that the experienced project manager is working in a global environment, and this course provides best practices for managing international trials and international outsourced service providers. 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 25, costs are $1,795.00

April 26-28, 2016

Comprehensive Monitoring for Medical Devices
San Francisco, CA

This course provides attendees with the skills they need to lead their domestic and global clinical trials to optimal performance. Building on basic and intermediate project management concepts, this course provides the experienced clinical professional with tactical information to overcome the most difficult issues encountered. Advanced concepts will be presented, including performance and time management, delay tracking and prevention, ensuring adequate regional patient supply and enrollment interest before beginning a trial, strategies when enrollment is not progressing, and ensuring high quality data on a global scale. Advanced concepts around root cause analysis and corrective and preventive action are also presented. It is likely that the experienced project manager is working in a global environment, and this course provides best practices for managing international trials and international outsourced service providers. 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 25, costs are $1,795.00

April 26-27, 2016

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 25, costs are $1,795.00

April 26-27, 2016

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

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

Take advantage of our $1,595.00 price by registering early! After March 25, costs are $1,795.00

May

May 3-5, 2016

CRA & CRC Beginner Program
San Diego, CA

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 April 1, costs are $1,895.00

May 3, 2016

Drug Development and FDA Regulations
Philadelphia, PA

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 April 1, costs are $1,000.00

May 3-4, 2016

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

This course will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity, especially in trials that involve imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity, while at the same time ensuring trial success, will be discussed. This course will also identify pre-award processes and institutional approaches to increasing fiscal return and mitigating fiscal compliance risk for clinical trials.

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

May 3-4, 2016

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.

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

May 3-4, 2016

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

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

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

May 4-5, 2016

Inspection Readiness: Demystifying the FDA Inspection Process
Philadelphia, PA

There is often fear and a mystique surrounding the process of an FDA site inspection. This workshop will include insights from a former FDA medical officer on the importance of Good Clinical Practices (GCPs) to help ensure sites are prepared for the FDA. Your instructor will show learners exactly what the FDA is looking for during a site inspection, and why these inspections are critical to both the drug/device approval process. This workshop will include presentations, discussions, and problem-solving using case studies applicable to both drug and device studies.

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