The focus of this workshop 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 project and performance management. This course is a must for new and aspiring managers.

Register by February 1 to save up to $200.00

This course provides information across the full range of medical device clinical trial activities. It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.

Register by February 1 to save up to $200.00

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.

Register by February 1 to save up to $200.00

Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. This course will describe the whole process, focusing on the clinical aspects of drug development. Multiple exercises will allow participants to gain an appreciation for team responsibilities and how people with different priorities work together for the common good. Following preparation of a development strategy, participants will prepare individual study designs that implement the strategy. The logistics of the process will be examined to optimize time and cost. The dynamic tension between a pharmaceutical company and regulatory agency will be examined in the context of optimizing development.

Register by February 1 to save up to $200.00

The person that has the most contact with the site is the 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. 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 have the 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 study managers in their skills.

Register by February 1 to save up to $200.00

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. 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 a compound achieving IRB and ultimately market approval.

Register by February 1 to save up to $200.00

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 safety information scientist.

Register by February 1 to save up to $200.00

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.

Register by February 1 to save up to $200.00

Maintaining the accuracy and adequacy of clinical trial documentation is both a critical component of Good Clinical Practice and a challenge in today’s rapidly changing clinical research environment. In this workshop, learners will focus on the regulatory requirements and practical implementation of three key study documentation components: electronic health records, essential documentation in the site’s study file, and Notes to File (NTFs).

Register by February 1 to save up to $200.00

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.

Register by February 7 to save up to $200.00

This course examines the evolution of the Institutional Review Board and how current events are shaping its future and that of the conduct of clinical research. Special attention is given to how IRBs can develop internal systems that assist in meeting their regulatory obligations of protecting human research participants in response to new requirements.

Register by February 7 to save up to $200.00

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.

Register by February 7 to save up to $200.00

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.

Register by February 7 to save up to $200.00

This course provides an excellent introduction to clinical data management in the pharmaceutical industry. Its focus on processes and their rationale renders it ideal for the new data manager and to other individuals who wish to learn basic clinical data management skills and the function of clinical data management in the drug development process.

Register by February 7 to save up to $200.00

This course will deliver an introduction to the basics of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. This course addresses the regulatory issues across global government 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 the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international safety and reporting standards.

Register by February 7 to save up to $200.00

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.”

Register by February 7 to save up to $200.00

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.

Register by February 7 to save up to $200.00

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.

Register by February 7 to save up to $200.00

This course provides an in-depth overview of Contract Research Organization (CRO) management, starting with reviewing of bids through follow-up analysis and debriefing of the CRO partnership.

Register by February 7 to save up to $200.00

Managing compliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, 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. Millions of dollars and countless hours are wasted every year on ineffective interventions because of inaccurate and/or inadequate issues management and root cause analysis. This course will present the concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC.

Register by February 7 to save up to $200.00

Adequate and accurate source documentation in clinical research is critical to ensuring subject safety, data integrity, and investigators meeting regulatory expectations. Appropriate monitoring of source data is also vital for the sponsor stakeholder performance. Best practices will be presented and applied as participants work through a simulated clinical research study from first subject, first visit, to site-close out - while examining source documentation from the perspective of the CRC, CRA, and the auditor. All of the regulatory required attributes of quality source data will be presented and applied using real-life case studies, simulations, and interactive group exercises. Participants, sponsors/CROs and/or research sites will gain new insights into the role source documentation plays in the clinical research process.

Register by February 15 to save up to $200.00

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.

Register by February 15 to save up to $200.00

This course provides an excellent introduction to and review of medical terminology for newcomers and seasoned professionals responsible for reviewing clinical charts, reviewing CRFs, and entering CRF data. Participants will receive a comprehensive overview and body system approach to understanding the root of medical terms, normal body system functions, and abnormal and disease states. Students will investigate the structure of medical terms, and analyze spoken and written health care communication.

Register by March 1 to save up to $200.00

In order to speed up the clinical research and product registration process, it is critical to carry out clinical studies outside what is considered traditional countries/regions (United States and Western Europe). However, conducting studies in developing countries requires very careful planning to succeed. Being ready to take full advantage of a global patient population can provide very positive patient access results, and today, emerging regions like Asia Pacific, Eastern Europe and Latin America play a very important role in global clinical trials. Accessing these populations requires an understanding of how to approach cultural differences, language barriers, and their unique regulatory environments.

Register by March 1 to save up to $200.00

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.

Register by March 8 to save up to $200.00

This refresher course provides additional training for the clinical research coordinator (CRC) with greater than three years of experience. We will start out with a review of the key governing regulations and guidelines in clinical research, and will then discuss trends, management issues and the financial impact of clinical research on the research site. We will also cover inspection preparation, as well as CAPA planning and implementation. This course will also focus on investigator responsibilities and developing processes that will ensure adequate investigator oversight.

Register by March 8 to save up to $200.00

A facilitator can be defined as an individual whose job is to help manage a process of information exchange. Clinical research team members’ roles include facilitation, but many are not trained in this skill set, even though it is one that is considered not inherent.

Facilitation has systemic impacts on the success of projects that depend on efficient information exchange. A Sponsor/CRO and/or Research Site team member’s success as a facilitator can greatly impact the success of a clinical trial, from patient recruitment to final report submission processes. This course defines facilitation specifically within a clinical research setting with a focus on successful clinical trials, including compliance performance improvement. The presentation is in a workshop format, providing application of facilitation tools presented.

Register by March 8 to save up to $200.00

This course is designed so that the participants walk away with usable skills and invaluable knowledge in clinical trial site visit report writing and review. The course combines lecture with real life scenarios, practicum exercises involving writing, editing and mapping of findings. Both beginners and those with experience will benefit from the content.

Register by March 8 to save up to $200.00

This course will describe how to implement signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the U.S. Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms. This course will cover signal assessment, use of signal triage algorithms, compliance with FDA guidance as specified in “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005, and the timing and frequency of signal detection, triage, and data mining runs.

Register by March 8 to save up to $200.00

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.

Register by March 11 to save up to $200.00

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.

Register by March 11 to save up to $200.00

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.

Register by March 11 to save up to $200.00

This course provides a comprehensive approach to the preparation and submission of FDA documents for approval of combination products. Participants receive a foundation of knowledge about the combination product process, submission preparation and the underlying scientific and regulatory principles involved.

Participants will gain knowledge about the FDA Office of Combination Products, the combination product process, request for designation submission, primary mode of action determination and the entire combination product system.

Register by March 11 to save up to $200.00

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.

Register by March 11 to save up to $200.00

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.

Register by March 11 to save up to $200.00

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.

Register by March 22 to save up to $200.00

The regulatory environment is constantly shifting and changing. This dynamism necessitates keeping abreast of current information from a variety of sources. Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. There is more to regulatory intelligence than keeping up with the latest regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, competitor information are just a few of the valuable sources of information that can help regulatory affairs professionals to develop successful regulatory strategies.

Register by March 22 to save up to $200.00

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.

Register by March 22 to save up to $200.00

This course provides a comprehensive approach to understanding FDA requirements for approval of a Biosimilar Product. Participants receive a foundation of knowledge about the Biosimilar Product approval pathway and the underlying Scientific/Quality/Regulatory principles involved. Guidelines for each aspect of research are provided. The FDA Stepwise Approach to demonstrating Biosimilarity will be discussed. General considerations on animal/clinical/in vitro studies will be reviewed, as well as the FDA’s Totality-of-the-Evidence approach.

Register by March 22 to save up to $200.00

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

Register by March 22 to save up to $200.00

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.

Register by March 22 to save up to $200.00

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.

Register by March 22 to save up to $200.00

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.

Register by March 22 to save up to $200.00

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as “periodic summary reporting” and “trend reporting.” In addition, the terms “advisory notice,” “near incident,” and “recall” have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents to follow them as well. Seminar topics include new terms and definitions, the guideline’s extended scope, reporting criteria and timelines, filing safety notices and field safety corrective actions, the vigilance aspects of revising Directive 2007/47/EC, and more.

Register by March 29 to save up to $200.00

This course examines global GCP compliance issues and GCP monitoring responsibilities. Participants explore GCP issues relevant to studies conducted within the US and abroad. There is a special focus on the culture issues impacting clinical research.

Register by March 29 to save up to $200.00

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.

Register by March 29 to save up to $200.00

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.

Register by March 29 to save up to $200.00

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 investigationaldrug 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.

Register by March 29 to save up to $200.00

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.

Register by March 29 to save up to $200.00

This course will review Clinical Data Management (CDM) operations as they relate to the conduct of clinical trials. The seminar will begin with an introduction to the regulations that directly impact CDM. From there, it will provide a high level overview of CDM processes and the stages of their execution, allowing clinical research professionals to understand the interconnectivity of CDM with other trial procedures. Study startup, timeline considerations, metrics generation, and a description of the differences between electronic data capture vs. paper-based studies will also be introduced.

Register by April 5 to save up to $200.00