MedEx Research Staffing: Your source for technical and scientific employment.
CenterWatch: Subscribe to Research Practitioner
Register for the 2nd Annual CenterWatch Forum on Optimizing Clinical Research Performance
To have your training program included, please contact jobwatch@centerwatch.com.

Training Programs

July | August | September

Phlebotomy Services

Phlebotomy Training in 3 days!

Nationwide

Learn to draw blood quickly. The program consists of 2 days of online training at your own pace and 1 day hands-on training in the classroom. We come to your location. Contact us now.
www.phleb.com/privategroups.html

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.

July

July 29-30, 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 June 27, costs are $1,795.00.

July 29-31, 2014

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 June 27, costs are $1,895.00.

July 30-31, 2014

Clinical Project Management: Introduction to Pratical Clinical Trial Planning for Project Managers

Philadelphia, PA

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 June 27, costs are $1,795.00.

August

August 12, 2014

Advanced Clinical Research Coordinator (CRC) Training

Philadelphia, PA

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.

Take advantage of our $800.00 price by registering early! After July 11, costs are $1,000.00.

August 12-13, 2014

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 11, costs are $1,795.00.

August 12-13, 2014

Monitoring Clinical Drug Studies: Intermediate

San Diego, 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 11, costs are $1,795.00.

August 12, 2014

Report Writing for CRAs

Philadelphia, PA

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.

Take advantage of our $800.00 price by registering early! After July 11, costs are $1,000.00.

August 12-13, 2014

Working with CROs: Building a Partnership for Project Success

San Diego, CA

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

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

August 14, 2014

Becoming a Preferred Site: Quality and Documentation Tips for Compliance

San Diego, CA

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

Take advantage of our $800.00 price by registering early! After July 11, costs are $1,000.00.

August 18-19, 2014

New Drug Product Development and Life Cycle Management

Course Level: Beginner

Boston, Massachusetts

This course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and minimize the risks associated with shepherding a new drug candidate through the development process.

At the end of this course, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.

Faculty: Courtland R. LaVallee, Director, Project Management, Theravance, Inc.

Overview

Register Online

August 18-19, 2014

Clinical Project Management

Course Level: Intermediate

Boston, Massachusetts

The practical hands-on activities in this course will help you create a custom operations plan for clinical trials. The course covers clinical project management from the planning stage through development, execution, and project close-down.

Faculty: Cris M. Howard, MBA, MEd, PMP Project Director, Global Project Management, Covance

Overview

Register Online

August 19-21, 2014

CRA & CRC: Beginner Program

San Diego, CA

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

Take advantage of our $1,695.00 price by registering early! After July 18, costs are $1,895.00.

August 19, 2014

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

Philadelphia, PA

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?

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

August 21-22, 2014

Biosimilar Products: Understanding FDA Requirements

San Francisco, CA

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.

Take advantage of our $1,595.00 price by registering early! After July 21, costs are $1,795.00.

August 26-28, 2014

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 25, costs are $1,895.00.

August 28, 2014

The Pharmacovigilance Audit: How to Prepare for an Inspection

Philadelphia, PA

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 July 25, costs are $1,000.00.

September

September 8-9, 2014

Planning and Conducting Global Clinical Trials

Philadelphia, PA

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

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

September 9, 2014

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 8, costs are $1,000.00.

September 9-10, 2014

Fraud in Clinical Research: Detection and Deterrence

Philadelphia, PA

The issue of fraud has once again become a focus within the clinical research industry. Although high-profile cases tend to periodically pique our interest, ensuring the integrity of data and the protection of participants during the conduct of clinical research is an ongoing process. Developing and incorporating systems for detecting and preventing fraud should be a standard part of any compliance plan.

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

September 9, 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 8, costs are $1,000.00.

September 9-10, 2014

Adverse Events: Managing and Reporting for Medical Devices

San Diego, 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 8, costs are $1,795.00.

September 9, 2014

Developing Clinical Study Budgets

Philadelphia, PA

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

Take advantage of our $800.00 price by registering early! After August 8, costs are $1,000.00.

September 9-10, 2014

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 8, costs are $1,795.00.

September 9-10, 2014

Fraud in Clinical Research: Detection and Deterrence

Philadelphia, PA

The issue of fraud has once again become a focus within the clinical research industry. Although high-profile cases tend to periodically pique our interest, ensuring the integrity of data and the protection of participants during the conduct of clinical research is an ongoing process. Developing and incorporating systems for detecting and preventing fraud should be a standard part of any compliance plan.

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

September 10, 2014

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 August 8, costs are $1,000.00.

September 10, 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 8, costs are $1,000.00.

September 10-11, 2014

Adverse Events: Managing and Reporting for Pharmaceuticals

San Diego, CA

This course provides an excellent introduction for newcomers to the field of drug and biologic product AE reporting, a comprehensive overview of current approaches and regulations for professionals in the field, and challenging questions and ideas for the experienced safety information scientist.

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

September 10-11, 2014

Clinical Project Management: Advanced

San Diego, CA

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

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

September 11, 2014

Regulatory Intelligence 101

San Diego, CA

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.

Take advantage of our $800.00 price by registering early! After August 11, costs are $1,000.00.

September 11, 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 August 22, costs are $1,000.00.

September 12, 2014

Regulatory Strategy 101

San Diego, CA

Drug development is getting more expensive by the year and a sound regulatory strategy can make or break a drug or biologic’s ability to initiate and support clinical trials or obtain marketing approval. Knowing what to research, review, negotiate and include in the regulatory strategy differs by company.

Take advantage of our $800.00 price by registering early! After August 11, costs are $1,000.00.

September 15, 2014

Development of a Clinical Study Report

Course Level: Beginner

Washington, DC

This fast-track course is designed for professionals new to clinical development and Clinical Study Report preparation. The Clinical Study Reports for submission to the Health Authorities are required to be in compliance with the International Conference on Harmonization (ICH) standards and must meet high quality standards so that it provides most concise yet comprehensive summary of the study. The course will provide you with the latest strategies for preparing such clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.

Faculty: Patricia A. Matone, PhD, President, Scientific Information Services LLC

Overview

Register Online

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.