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Online

Clinical Investigator: eLearning Program

Overview: This eLearning program is designed to provide a practical, realistic context in which to help clinical research professionals learn about conducting clinical trials. Using an interactive case study, the program follows the activities of a fictitious clinical investigator and his staff as they conduct a clinical trial for a fictitious drug.

Purchase both Modules and Save $100.

Clinical Investigator: Module 1 - Study Preparation and Initiation

Module 1 deals with the activities that occur before a clinical trial begins: study preparation and study initiation.

Clinical Investigator: Module 2 - Conducting The Study

Module 2 focuses on activities that occur during the trial.

September

September 16-18, 2014

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 15, costs are $1,895.00.

September 17-18, 2014

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 15, costs are $1,795.00.

September 18, 2014

Informed Consent Content & Process Requirements for Biobanking Studies

Seattle, WA

This course presents the elements of the informed consent document and the components of the process, specifically as they relate to biobanking studies. Industry specific scenarios are presented to reinforce important concepts, for example: Wording considerations given FDA’s recent feedback, execution timing, evaluating and documenting capacity to consent, voluntariness, when a HIPAA authorization is required, withdrawal of consent, and more. Discussions also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.

Take advantage of our $800.00 price by registering early! After August 18, costs are $1,000.00.

September 19, 2014

Good Clinical Practice for the Laboratory Scientist

Boston, MA

This course is designed particularly for the laboratory scientist to provide an appreciation of the regulated environment in which clinical studies are conducted and its relevance when collecting and analyzing biological specimens during a study. The drug development process (discovery through post-market) will be reviewed with particular attention to the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and where/how they apply. Examples and the impact of non-compliance will be discussed. Review and reinforcement of important concepts, such as laboratory accreditation, will be achieved through discussion and examples. The role of quality management in GCP Laboratories will be evaluated along with the standards to have in place that will ensure compliance, including outsourcing clinical laboratory activities. The challenges when conducting global studies related to specimen collection will also be discussed.

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

September 22-23, 2014

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 22, costs are $1,795.00.

September 22-23, 2014

Advanced Good Clinical Practice: Practical Application and Implementation

San Diego, CA

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 August 22, costs are $1,795.00.

September 23-24, 2014

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 August 22, costs are $1,795.00.

September 23-24, 2014

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

San Diego, CA

This training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.

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

September 23-24, 2014

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 August 22, costs are $1,795.00.

September 24-25, 2014

Clinical Trials for Medical Devices: Design and Development

Philadelphia, PA

This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between FDA and sponsors to provide clear direction to support marketing of the medical device.

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

September 25, 2014

Informed Consent - Beyond the Basics

Philadelphia, PA

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 August 22, costs are $1,000.00.

September 25, 2014

The Pharmacovigilance Audit: How to Prepare for an Inspection

San Diego, CA

Large and small pharmaceutical companies alike face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The specialized operational configurations of firms present complex challenges to meeting international requirements effectively. Pharmacovigilance audits can contribute to regulatory compliance and support industry best practices. This course will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company’s pharmacovigilance operations to applicable best practices.

Take advantage of our $800.00 price by registering early! After August 22, costs are $1,000.00.

September 26, 2014

Effective Recruitment Planning and Management for Sponsors and CROs

Philadelphia, PA

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 August 22, costs are $1,000.00.

October

October 1-2, 2014

Combination Products: How to Get a Product Through The FDA Approval Process

Boston, MA

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.

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

October 3, 2014

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.

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

October 7-8, 2014

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 December 24, costs are $1,795.00.

October 9, 2014

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. This is a highly practical course with real-world tips from persons in the field who create, review, and audit these documents.

Take advantage of our $800.00 price by registering early! After October 6, costs are $1,000.00.

October 14-15, 2014

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 12, costs are $1,795.00.

October 16-17, 2014

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 15, costs are $1,795.00.

October 20-21, 2014

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 19, costs are $1,795.00.

October 21-22, 2014

Data Management in the Electronic Data Capture Arena

Philadelphia, PA

This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process. Although the basic data management principles remain the same, for example good CRF design and ensuring the integrity of the data, the timelines and tasks surrounding today’s EDC are not interpreted exactly as the paper CRF process has previously dictated. The understanding of how the technology has changed the process will enable today’s Data Managers to move forward in the discipline and ensure their place as viable members of the clinical study team. As electronic data capture utilized as patient e-source or eCRF becomes more the routine, it is important that the CDM be fully aware of the capabilities of the EDC application in order to ensure a comprehensive data management component in the clinical trial conduct.

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

October 22-23, 2014

Global GCP Monitoring: Domestic and International Compliance

Philadelphia, PA

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.

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

October 22-23, 2014

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 September 22, costs are $1,795.00.

October 23, 2014

Risk-Based Monitoring: Successful Planning and Implementation

San Francisco, 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 September 23, costs are $1,000.00.

October 23-24, 2014

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 23, costs are $1,795.00.

October 23, 2014

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 September 23, costs are $1,000.00.

November

November 4-5, 2014

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

San Diego, CA

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

Take advantage of our $1,595.00 price by registering early! After October 3, costs are $1,795.00.

November 4, 2014

Drug Development and FDA Regulations

Boston, MA

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

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

November 5-6, 2014

Introduction to Clinical Data Management

Philadelphia, PA

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 medical product development process.

Take advantage of our $1,595.00 price by registering early! After October 3, costs are $1,795.00.

November 5-6, 2014

The CRA Manager Course

Boston, MA

The focus of this course is to strengthen the skills required of the CRA Manager to effectively manage,motivate, and optimize the performance of CRA teams. In this course, you will sharpen your people skills and develop an understanding of the key components of successful team and performance management. This course is a must for new and aspiring managers. Several document templates will be provided for you to customize and use during your daily activities as a Manager. Examples and interactive exercises will pertain specifically to managing Clinical Research Associates (CRAs).

Take advantage of our $1,595.00 price by registering early! After October 3, costs are $1,795.00.

November 6, 2014

How to Write Great SOPs and Work Instructions

Philadelphia, PA

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 October 6, costs are $1,000.00.

November 6, 2014

Developing Effective Training and Facilitation Skills in Clinical Research: An Application-Based Course

San Diego, CA

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 6, costs are $1,000.00.

November 6, 2014

Facilitation Skills for Clinical Research Team Members

Philadelphia, PA

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; yet few clinical research professionals have ever received training on this critical skill set.

Take advantage of our $800.00 price by registering early! After October 6, costs are $1,000.00.

November 7, 2014

Clinical Trial Documentation: Electronic Health Records, Essential Documents, and the Use of Notes to File

Boston, MA

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).

Take advantage of our $800.00 price by registering early! After October 6, costs are $1,000.00.

November 10-11, 2014

Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research

Philadelphia, PA

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.

Take advantage of our $1,595.00 price by registering early! After October 10, costs are $1,795.00.

November 11-12, 2014

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

Philadelphia, PA

This course highlights new changes to medical device regulations and provides an overview to the submission of documents to the FDA for approval of medical device products. Participants gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to provide the FDA with necessary information and obtain product approval.

Take advantage of our $1,595.00 price by registering early! After October 10, costs are $1,795.00.

November 12, 2014

SOP Writing: How to Create, Implement, and Maintain User-Friendly SOPs

San Diego, CA

In the world of clinical research, it would be difficult to find someone who hasn’t heard of Standard Operating Procedures (SOPs). Yet there remains great mystery in how to create an SOP. SOPs require a lot of explanation: What are the basics? How many are enough? How many are too many? Who creates them? Who monitors them? How do we train them? How often do we train them? How do we document that training? Where should SOPs live? Should they be controlled documents, or is a Note to File sufficient? All of these questions leave many of us overwhelmed and wondering what to do. So we procrastinate, we ignore, and we find other projects that are much more rewarding. But the SOP can be a very powerful tool.

Take advantage of our $800.00 price by registering early! After October 10, costs are $1,000.00.

November 13, 2014

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 October 10, costs are $1,000.00.

November 13, 2014

Signal Detection and Pharmacovigilance

Philadelphia, PA

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.

Take advantage of our $800.00 price by registering early! After October 10, costs are $1,000.00.

November 13-14, 2014

Monitoring Clinical Drug Studies: Advanced

San Francisco, CA

This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non- compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.

Take advantage of our $1,595.00 price by registering early! After October 10, costs are $1,795.00.

November 20-21, 2014

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 October 20, costs are $1,795.00.

December

December 1-2, 2014

Advanced Good Clinical Practice: Practical Application and Implementation

Boston, MA

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

Take advantage of our $1,595.00 price by registering early! After October 31, costs are $1,795.00.

December 2-3, 2014

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 October 31, costs are $1,795.00.

December 2-3, 2014

Data Management in the Electronic Data Capture Arena

San Diego, CA

This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process.

Take advantage of our $1,595.00 price by registering early! After October 31, costs are $1,795.00.

December 2-3, 2014

Data Management in the Electronic Data Capture Arena

San Diego, CA

This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process.

Take advantage of our $1,595.00 price by registering early! After October 31, costs are $1,795.00.

December 2-4, 2014

CRA & CRC Beginner Program

Philadelphia, PA

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC. Specifically, this course is appropriate for individuals seeking a new career or career change, but don’t know which job track within clinical research to pursue. The course includes an appendix of time management and interviewing tips.

Take advantage of our $1,695.00 price by registering early! After October 31, costs are $1,895.00.

December 2, 2014

Informed Consent - Beyond the Basics

San Francisco, CA

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

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

December 3-4, 2014

Medical Device GCP Overview

Boston, MA

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

Take advantage of our $1,595.00 price by registering early! After November 3, costs are $1,795.00.

December 3-4, 2014

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

Boston, MA

Product safety makes headlines every day -- and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. Are you confident your current pharmacovigilance operations will meet the latest US and EU expectations for compliance and keep your products on the market? Do you understand the processes needed to perform adequate risk assessment?

Take advantage of our $1,595.00 price by registering early! After November 3, costs are $1,795.00.

December 3, 2014

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.

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

December 3-4, 2014

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 safety information scientist.

Take advantage of our $1,595.00 price by registering early! After November 3, costs are $1,795.00.

December 4-5, 2014

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.

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