The Almac Group is hosting its third international series of complimentary workshops this spring, titled “Protocol to Patient: Managing Clinical Supplies in an Evolving Marketplace.”

The day-long, interactive workshops are intended for clinical trial/outsourcing professionals from pharmaceutical and biotech companies. Their goal is to introduce and propose strategies for successful clinical supply chain management, ranging from packing design considerations to global distribution.

To register for an event near you, visit the registration sites here. Seats are limited and registration is required to secure your place.

The Almac Group is hosting its third international series of complimentary workshops this spring, titled “Protocol to Patient: Managing Clinical Supplies in an Evolving Marketplace.”

The day-long, interactive workshops are intended for clinical trial/outsourcing professionals from pharmaceutical and biotech companies. Their goal is to introduce and propose strategies for successful clinical supply chain management, ranging from packing design considerations to global distribution.

To register for an event near you, visit the registration sites here. Seats are limited and registration is required to secure your place.

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 3, costs are $1,795.00.

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

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

The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

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

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 3, costs are $1,795.00.

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

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

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

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

This course will deliver an introduction to the basics of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. This course addresses the regulatory issues across global government agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international safety and reporting standards.

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

This course will focus on more complex and challenging issues affecting the Clinical Research Professional 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 3, costs are $1,795.00.

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

Take advantage of our $1,595.00 price by registering early! After May 6, costs are $1,795.00.

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

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

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

Take advantage of our $1,595.00 price by registering early! After May 6, costs are $1,795.00.

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

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

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 10, costs are $1,795.00.

This course provides an in-depth overview of the medical device development process and the role of the Clinical Research Associate (CRA) in managing and monitoring medical device studies. This course is ideal for CRAs new to the device industry, as well as experienced CRAs who are transitioning from monitoring drug studies to monitoring device studies.

Take advantage of our $1,695.00 price by registering early! After May 10, costs are $1,895.00.

Globalization is a core component of the business models of pharmaceutical companies, and includes the conduct of clinical trials. Major drivers are the anticipated lower costs of research, the large pool of (treatment naive) patients, expected lower regulatory investments, and access to emerging economies. This makes the conduct of clinical trials also in resource-limited settings attractive. However, the complexity of social and ethical issues of clinical research must not be underestimated and neglected. Predictable risks and burdens must be compared to foreseeable benefits for the participants or communities under investigation. This mandates any sponsor conducting trials in resource limited settings to come up with fair and practicable solutions. Sensitivity for cultural differences is key when interacting with local investigators, authorities, monitors, and study participants. Good local knowledge is needed to navigate the challenges of the regulatory landscape. Particularly in Africa, capacities and in rastructure must often be strengthened, and many achievements taken for granted in the Western research world may pose barriers in resource-limited settings.

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

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 10, costs are $1,795.00.

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

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

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate - with a focus on developing tools and identifying current industry trends and challenges for effective monitoring. FDA/Regulatory Authority inspection findings will be used throughout the seminar to emphasize critical areas in monitoring and managing site compliance. Industry standards/best practices will be discussed with an emphasis on the Sponsor/CRO-Site/Subject relationship. References and resources (including those available online) will be provided. Topics include site management, developing or identifying and modifying tools for effective monitoring and co-monitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials such as adverse event reporting and managing non-compliant or underperforming sites.

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

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

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

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate - with a focus on developing tools and identifying current industry trends and challenges for effective monitoring. FDA/Regulatory Authority inspection findings will be used throughout the seminar to emphasize critical areas in monitoring and managing site compliance. Industry standards/best practices will be discussed with an emphasis on the Sponsor/CRO-Site/Subject relationship. References and resources (including those available online) will be provided. Topics include site management, developing or identifying and modifying tools for effective monitoring and co-monitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials such as adverse event reporting and managing non-compliant or underperforming sites.

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

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

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

The focus of this workshop is to strengthen the skills required of the CRA Manager to effectively manage, motivate and optimize the performance of CRA teams. In this course, you will sharpen your people skills and develop an understanding of the key components of successful project and performance management. This course is a must for new and aspiring managers.

Take advantage of our $1,595.00 price by registering early! After May 17, costs are $1,795.00.

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. Activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts.

Take advantage of our $1,695.00 price by registering early! After May 17, costs are $1,895.00.

This one-day course is a primer and overview to the 510(k) premarket notification process. A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval (PMA). There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807, as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Take advantage of our $800.00 price by registering early! After May 17, costs are $1,000.00.

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 17, costs are $1,000.00.

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 17, costs are $1,000.00.

Designed for non-statisticians, this basic statistical concepts workshop has direct applicability to clinical research. The choice of statistical method, the application of statistical principles, and the interpretation of statistical results are the foundation of the design and analysis of clinical trials. It is therefore critical that statistical methods are fully understood before they are implemented. This course is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Please note that this is not a course on statistical formulas or computations.

Take advantage of our $1,595.00 price by registering early! After May 24, costs are $1,795.00.

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and ultimately market approval.

Take advantage of our $1,595.00 price by registering early! After May 24, costs are $1,795.00.

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates and Clinical Research Coordinators. It explores topics relevant to those considering a career as an entry-level monitor or site coordinator. 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.

Take advantage of our $1,695.00 price by registering early! After May 24, costs are $1,895.00.

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 24, costs are $1,795.00.

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

Take advantage of our $1,595.00 price by registering early! After May 24, costs are $1,795.00.

This course provides attendees with the skills they need to lead their domestic and global clinical trials to optimal performance. Building on basic and intermediate project management concepts, this course provides the experienced clinical professional with tactical information to overcome the most difficult issues encountered. Advanced concepts will be presented, including performance and time management, delay tracking and prevention, ensuring adequate regional patient supply and enrollment interest before beginning a trial, strategies when enrollment is not progressing, and ensuring high quality data on a global scale. 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 24, costs are $1,795.00.

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

Take advantage of our $1,595.00 price by registering early! After May 24, costs are $1,795.00.

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. Activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts.

Take advantage of our $1,695.00 price by registering early! After June 21, costs are $1,895.00.

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 June 21, costs are $1,795.00.

This course is an introduction to clinical project management in the pharmaceutical industry. The focus is on individuals who want to learn basic project management skills and how they can be applied to the drug development process,especially in the management of clinical trials. The needs of relatively new project managers who are not familiar, or experienced, with specific technical tasks involved in clinical trial management are addressed. There is specific focus on the need to anticipate, understand,and implement detailed project management activities in a proactive manner. This course includes discussion of a highly detailed and fully developed clinical trial management process map. Discussions of the process map are practically oriented with emphasis given to useful advice that, when implemented, will assist with trial management.

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

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

Take advantage of our $800.00 price by registering early! After July 12, costs are $1,000.00.

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate - with a focus on developing tools and identifying current industry trends and challenges for effective monitoring. FDA/Regulatory Authority inspection findings will be used throughout the seminar to emphasize critical areas in monitoring and managing site compliance. Industry standards/best practices will be discussed with an emphasis on the Sponsor/CRO-Site/Subject relationship. References and resources (including those available online) will be provided. Topics include site management, developing or identifying and modifying tools for effective monitoring and co-monitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials such as adverse event reporting and managing non-compliant or underperforming sites.

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

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

Take advantage of our $800.00 price by registering early! After July 12, costs are $1,000.00.

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 12, costs are $1,795.00.

The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

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

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates and Clinical Research Coordinators. It explores topics relevant to those considering a career as an entry-level monitor or site coordinator. 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.

Take advantage of our $1,695.00 price by registering early! After July 19, costs are $1,895.00.

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

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

This one-day course is a primer and overview to the 510(k) premarket notification process. A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval (PMA). There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807, as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Take advantage of our $800.00 price by registering early! After July 25, costs are $1,000.00.

Standard Operating Procedures (SOPs) and Work Instructions are of high value when they are written properly. Too often authors leave out the right details to make these documents user-friendly and add-in items can cause confusion and lead to misunderstandings and at worse, non-compliance. This course presents a best practice for developing SOPs and Work Instructions starting with the critical technique of process mapping. In this seminar, learners will be taught the various components of each document and tips on how to write effective, user-friendly SOPs and Work Instructions. Participants will have an opportunity to bring a draft SOP and/or Work Instruction to the class and obtain feedback.

Take advantage of our $800.00 price by registering early! After July 25, costs are $1,000.00.

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. Activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts.

Take advantage of our $1,695.00 price by registering early! After July 25, costs are $1,895.00.

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

Take advantage of our $1,595.00 price by registering early! After July 25, costs are $1,795.00.

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 9, costs are $1,795.00.