CenterWatch

Training Programs

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

July

July 26-27, 2016

Auditing Techniques for Clinical Research Professionals
San Diego, 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.

Commercial - $1,795.00

August

August 2-3, 2016

Pharmacovigilance in Europe: Impact of Regulatory Changes on Investigational & Marketed Products
San Francisco, CA

The ICH process has resulted in multiple initiatives aimed at harmonizing global regulatory requirements for the approval and marketing of pharmaceuticals. The EU has faced the additional challenge of harmonizing disparate regulations and practices across multiple cultures and languages. This course will cover the essential ICH pharmacovigilance guidelines for investigational and marketed products, as they have been being implemented in Europe. The current Volume 9A and Volume 10 nd the implications of the new EU marketed product guidelines will be discussed in detail, including...

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

August 2-4, 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 July 1, costs are $1,895.00

August 2-3, 2016

Monitoring Oncology Clinical Trials
Philadelphia, PA

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 July 1, costs are $1,795.00.

August 15-16, 2016

Design and Conduct of Clinical Trials: Design Requirements, Statistical Issues, and Clinical Protocols
San Francisco, CA

Clinical trials plays a pivotal role in evidence-based medicine. This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical research. Topics will include basic principles and current methodologies used in the design, implementation, and analysis of clinical trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, assignment of study treatments, endpoints, randomization procedures, sample size determination, data analysis, adverse event reporting, and protocol compliance monitoring. The ethical issues that arise at each phase of new biomedical product development will also be explored.

Take advantage of our $1,595.00 price by registering early! After July 14, costs are $1,795.00

August 16, 2016

Becoming a Preferred Site: Quality and Documentation Tips for Compliance
Philadelphia, PA

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 July 15, costs are $1,000.00

August 16-17, 2016

Monitoring Clinical Drug Studies: Intermediate
San Francisco, CA

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 July 15, costs are $1,795.00

August 16-17, 2016

The Future of Clinical Trial Conduct Demands a Quality System Approach: Will You be Ready?
San Francisco, 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 July 15, costs are $1,795.00

August 16-17, 2016

Working with CROs: Building a Partnership for Project Success
San Francisco, 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 July 15, costs are $1,795.00

August 23-24, 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 July 22, costs are $1,795.00

August 24, 2016

Detecting Risk Signals in Protocols, Data, and Monitoring
Philadelphia, PA

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 July 22, costs are $1,000.00.

August 24-25, 2016

Introduction to Clinical Research
Boston, MA

This two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable. 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 July 22, costs are $1,795.00.

August 26, 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. It is important to consider how essential every teleconference, meeting, and conversation is within research; the information shared can have a huge impact on study timelines, data integrity, and compliance. If information is not internalized by the learner, then the time spent discussing it is a waste and the consequences may be significant.

Take advantage of our $800.00 price by registering early! * After October 3, costs are $1,000.00.

August 27-28, 2016

Drug Discovery: The Path from Development to Marketing Approval
Boston, MA

This course will introduce the concept of translational approach in clinical research and examine its application. An overview of state-of-the-art translational technologies will be provided. Topics will include review of molecular and pathophysiological aspects of several diseases, and the exploration basis for drug design, pre-clinical,and clinical testing. Additional topics will include clinical evaluation, regulatory approval of biological drugs, and frontiers in translational research. We will review requirements for transitions from the pre-clinical phase of drug development to the clinical trial process and subsequently to marketing of a new drug. In addition, the phases of clinical drug development that are part of the InvestigationalNew Drug (IND) application will be discussed. The New Drug Application (NDA) pre-market application process and regulatory requirements will then be reviewed with insight into possible post-NDA activities that may be required.

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

September

September 6-7, 2016

Clinical Project Management Advanced
San Diego, CA

This course focuses on the most difficult skills project managers need to acquire in order to lead their domestic and global clinical trials to optimal performance. It provides the experienced R&D professional with practical and tactical project management information to efficiently manage their projects.

Advanced concepts are introduced building on basic and intermediate project management techniques and essential tools for planning and managing time, efficiently tracking and preventing delays, accurately estimating cost, and developing a clinical trial budget. Communication techniques are thoroughly detailed with the purpose of giving participants the knowledge to get their team members and stakeholders fully committed to their project and to improve the global performance of clinical trials they are managing. Project management best practices for managing contract service providers are detailed. The course provides practical tools and processes but also focuses on useful information for improving sponsor/CRO relationships. The course covers major concepts for managing and resourcing multiple projects. Advanced techniques and processes for clinical research risk analysis, root cause analysis and corrective and preventive action (CAPA) are also presented together with the latest regulatory expectations and guidelines. The course concludes with practical techniques for optimizing the decision-making process and improving R&D productivity. This course is designed to be interactive and includes case studies, quizzes with short role-playing exercises, and sharing of experience.

Take advantage of our $1,595.00 price by registering early! * After October 14, costs are $1,795.00.

September 6-7, 2016

Conducting Clinical Trials Under ICH GCP
Philadelphia, PA

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

Take advantage of our $1,595.00 price by registering early! * After August 5, costs are $1,795.00.

September 6-8, 2016

Monitoring Clinical Drug Studies: Beginner
San Francisco, CA

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 August 5, costs are $1,895.00.

September 6-7, 2016

The CRA Manager Course
San Francisco, 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 August 5, costs are $1,795.00.

September 7, 2016

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

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

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

September 8-9, 2016

Adverse Events: Managing and Reporting for Medical Devices
San Francisco, CA

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 August 5, costs are $1,795.00.

September 8-9, 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 August 5, costs are $1,795.00.

September 13-15, 2016

Comprehensive Monitoring for Medical Devices
Boston, MA

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 August 12, costs are $1,895.00.

September 14-15, 2016

Effectively Writing Clinical Trial Protocols
Boston, MA

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

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

September 16, 2016

Medical Writing Fundamentals: How to Write Regulatory Documents
Boston, MA

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 August 12, costs are $1,000.00.

September 27-28, 2016

Clinical Project Management: Introduction to Practical Clinical Trial Planning for Project Managers
San Francisco, 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 August 26, costs are $1,795.00.

September 27-29, 2016

CRA & CRC Beginner Program
San Francisco, 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 August 26, costs are $1,895.00.

September 27-28, 2016

Medical Device Approval Process: Preparation and Processing of 510(k)s, IDEs, and PMAs
San Francisco, 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 August 26, costs are $1,795.00.

September 27, 2016

Risk-Based Monitoring: Successful Planning and Implementation
Philadelphia, PA

A fundamental shift is occurring in the clinical research industry related to how sponsors satisfy their regulatory and GCP requirements for the adequate monitoring of clinical trials. Recent regulatory authority guidance and industry initiatives are both promoting a modern approach to clinical trial monitoring based upon program and study-specific risk assessments and mitigation plans. In order for clinical research professionals to embrace this industry shift, it is critical that they understand the rationale, concepts, and actual work practices inherent in risk-based monitoring. This course is designed for clinical research professionals across the spectrum of research organizations, investigational product types, and experience levels. Participants will acquire a deeper understanding of the philosophy of risk-based monitoring and be able to apply this understanding to operational activities including the following...

Take advantage of our $800.00 price by registering early! * After August 26, costs are $1,000.00.

September 28-29, 2016

Monitoring Clinical Drug Studies: Advanced
Philadelphia, PA

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 August 26, costs are $1,795.00.

October

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.