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Training Programs

April | May | June | July

April

April 22-23, 2014

Biosimilar Products: Understanding FDA Requirements

San Diego, 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 March 21, costs are $1,795.00.

April 22-23, 2014

Auditing Techniques for Clinical Research Professionals

San Diego, CA

This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

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

April 22-23, 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 March 21, costs are $1,795.00.

April 22, 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?

Take advantage of our $800.00 price by registering early! After March 21, costs are $1,000.00.

April 23-24, 2014

Comprehensive CRC Training

Philadelphia, PA

This course provides an in-depth survey of the roles and responsibilities of the investigator site Clinical Research Coordinator (CRC). The course begins with an overview of the drug development process and regulatory environment in which the CRC operates. From there, critical CRC responsibilities will be discussed, including patient recruitment and retention, informed consent, adverse event reporting, and investigational product accountability. The CRC’s role at the site will be explored, from study start-up through site close-out, and all of the activities, site visits, and documentation that occur along the way. Finally, site audits and inspections will be reviewed, with an emphasis on the CRC’s role in that process.

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

May

May 1, 2014

Drug Development and FDA Regulations

Philadelphia, PA

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

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

May 5-6, 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 April 11, costs are $1,795.00.

May 6-7, 2014

The Highly Effective CRA: Soft Skills for Taking Your Work to the Next Level

Philadelphia, PA

Good monitoring skills are not the only critical skills a CRA needs to be effective in their role. A highly effective CRA is a great communicator; focuses on building relationships and partnership with their key stakeholders to position their projects/studies for success; resolves conflict with confidence, bravery, and laser-sharp solution focus; is able to anticipate potential challenges and barriers to success and takes the steps to remove and/or mitigate them; and identifies and solves problems.

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

May 6-8, 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 April 4, costs are $1,895.00.

May 6-7, 2014

Conducting Clinical Trials Under ICH GCP

Boston, MA

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 April 4, costs are $1,795.00.

May 6-7, 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 April 4, costs are $1,795.00.

May 6-7, 2014

Clinical Project Management: Introduction to Pratical 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 April 4, costs are $1,795.00.

May 6-7, 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 April 4, costs are $1,795.00.

May 7-8, 2014

Understanding Clinical Data Management for the non-CDM Professional

San Diego, CA

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.

Take advantage of our $1,595.00 price by registering early! After April 7, costs are $1,795.00.

May 7-8, 2014

Clinical Trials for Medical Devices: Design & Development

San Diego, CA

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 April 7, costs are $1,795.00.

May 7-8, 2014

Patient Registry Programs: Strategy, Design, Operations, and Output

San Diego, CA

This course is designed to serve biopharmaceutical industry participants who wish to gain a comprehensive understanding of patient registry programs. Topics are introduced at the basic level but rapidly progress to cover more advanced, in-depth, and complex issues in program development and implementation. The seminar provides tools for participants involved in registry planning and design as well as for participants involved in registry project management and operations.

Take advantage of our $1,595.00 price by registering early! After April 7, costs are $1,795.00.

May 12-13, 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 April 11, costs are $1,795.00.

May 13, 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 April 11, costs are $1,000.00.

May 13, 2014

Good Clinical Pratice for the Laboratory Scientist

Philadelphia, PA

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 April 11, costs are $1,000.00.

May 14, 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 April 11, costs are $1,000.00.

May 19, 2014

Regulatory Intelligence 101

Philadelphia, PA

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 April 11, costs are $1,000.00.

June

June 2-3, 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 May 2, costs are $1,795.00.

June 3-4, 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 May 2, costs are $1,795.00.

June 4-5, 2014

Biosimilar Products: Understanding FDA Requirements

Philadelphia, PA

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 May 2, costs are $1,795.00.

June 4-5, 2014

Clinical Project Management: Intermediate

Boston, MA

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 May 2, costs are $1,795.00.

June 4-5, 2014

Data Management in the Electronic Data Capture Arena: Regulatory Considerations and Practical Applications for eCDM

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 May 2, costs are $1,795.00.

June 5-6, 2014

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

Philadelphia, PA

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.

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

June 5, 2014

Trial Master Files: Why They Are Important and How to Organize Them

Boston, MA

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND. The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP, Section 8.1 defines these Essential Documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. They are all also eligible for inspection by the regulatory authorities at any time during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics and devices. It is, therefore, paramount that these documents are filed in a way to make them immediately accessible for use by the study team and for regulatory inspection. This module will provide some practical solutions to meet these challenges.

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

June 6, 2014

Case Report Form Design, Strategy, and Standards

Philadelphia, PA

According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”

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

June 10-11, 2014

Adverse Events: Managing and Reporting for Pharmaceuticals

Boston, MA

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 May 9, costs are $1,795.00.

June 10, 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 May 9, costs are $1,000.00.

June 10-11, 2014

Developing CRAs as Site Study Managers

Philadelphia, PA

The person that has the most contact with the site is the Clinical Research Associate (CRA); they are the “face” of the sponsor, the purveyor of information, and the person that most influences the site’s performance on a study. In a sense, CRAs are the sponsor’s On-Site Study Managers. It is critical that this individual be in a position to positively reflect the sponsor and ensure the site performs to their full potential through training, knowledge, and support. CRAs must understand the data review process, but they must also havethe skills to train, mentor, and communicate with new and experienced site staff, and to navigate the path through challenging situations. In addition, the CRA needs to be equipped and prepared to communicate with the Principal Investigator (PI) and be able to support the site in recruitment efforts and the documentation process. A better understanding of adult learning techniques, unique and thorough approaches to recruitment and retention strategies, carefully developed and implemented communication plans, and an understanding of project management techniques can make the difference between a site meeting enrollment with minimal deviations, and a site lacking in enrollment with multiple protocol violations. This course will focus on a variety of techniques and training to help CRAs move from monitors to on-site study managers in their skills.

Take advantage of our $1,595.00 price by registering early! After May 9, costs are $1,795.00.

June 10-12, 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 May 9, costs are $1,895.00.

June 11-12, 2014

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

Boston, MA

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 May 9, costs are $1,795.00.

June 11-12, 2014

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

Boston, MA

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 May 9, costs are $1,795.00.

June 12-13, 2014

Working with CROs: Building a Partnership for Project Success

Philadelphia, PA

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 May 12, costs are $1,795.00.

June 12-13, 2014

Introduction to Clinical Data Management

Boston, MA

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 May 12, costs are $1,795.00.

June 17-18, 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 May 16, costs are $1,795.00.

June 17-19, 2014

Monitoring Clinical Drug Studies: Beginner

Boston, MA

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 May 16, costs are $1,895.00.

June 18-19, 2014

The CRA Manager Course

Philadelphia, PA

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 May 16, costs are $1,795.00.

June 20, 2014

Query Creation and Processing: Assessing Data Discrepancies and the Communications for Corrections

Philadelphia, PA

This course is designed to build the foundational understanding of the identification of discrepancies in the data that are collected for a clinical trial protocol. Query processing begins with a functional understanding of the study and study documents. There will be a sample protocol to review along with the case report forms (CRFs) which will allow you to understand the study as well as the data collection instruments. Supplemental information and the Data Management Plan (DMP), will provide the data quality checks (or “edit checks”) that will describe the data logic and information that is expected on the CRFs.

Take advantage of our $800.00 price by registering early! After May 16, costs are $1,000.00.

June 20, 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 May 16, costs are $1,000.00.

June 23-24, 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 May 23, costs are $1,795.00.

June 24, 2014

Risk-Based Monitoring: Successful Planning and Implementation

Philadelphia, PA

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

Take advantage of our $800.00 price by registering early! After May 23, costs are $1,000.00.

June 24-25, 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 May 23, costs are $1,795.00.

June 25-27, 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 May 23, costs are $1,895.00.

June 25-26, 2014

Auditing Techniques for Clinical Research Professionals

Philadelphia, PA

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 May 23, costs are $1,795.00.

June 25-26, 2014

Monitoring Clinical Drug Studies: Intermediate

Boston, MA

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

Take advantage of our $1,595.00 price by registering early! After May 23, costs are $1,795.00.

June 25-26, 2014

Clinical Project Management: Advanced

Philadelphia, PA

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 May 23, costs are $1,795.00.

June 25-26, 2014

Drug Approval Process: Preparation and Processing of INDs and NDAs

Philadelphia, PA

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 May 23, costs are $1,795.00.

June 26-27, 2014

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

Boston, MA

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

Take advantage of our $1,595.00 price by registering early! After May 23, costs are $1,795.00.

June 26, 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 May 23, costs are $1,595.00.

July

July 22-24, 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 June 20, costs are $1,895.00.