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

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

Register by May 4 to save up to $200.00
This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

Register by May 4 to save up to $200.00
The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

Register by May 4 to save up to $200.00
This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

Register by May 4 to save up to $200.00
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.

Register by May 4 to save up to $200.00
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.

Register by May 4 to save up to $200.00
The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and ultimately market approval.

Over the course of any development plan, new protocols, protocol amendments, and protocol concept sheets will be needed on an ongoing basis. Though they require similar information, protocols for Phases 1, 2, 3 and 4 require different writing approaches. As a writer of a protocol, you need to know what the agency expects to see at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process. Amendments need to be managed efficiently to avoid costly implementation or delays to the ongoing trial.

Register by May 4 to save up to $200.00
This course provides an excellent introduction for newcomers to the field of drug and biologic product adverse event reporting, a comprehensive overview of current approaches and regulations for professionals in the field, and challenging questions and ideas for the experienced clinical research professional.

Register by May 11 to save up to $200.00
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 are currently being implemented in Europe, together with other approaches to standardization such as CIOMS reports.

Register by May 11 to save up to $200.00
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.

Register by May 11 to save up to $200.00
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.

Register by May 11 to save up to $200.00
This fundamental "how to" and "why" workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. Activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts.

Register by May 11 to save up to $200.00
As drug companies seek to penetrate global markets and get new drugs to markets more quickly, they are increasingly conducting drug and biologic clinical studies outside the United States. The regulatory affairs professional must keep abreast of the ever-changing regulatory climate, and be able to complete IND-like submissions in a variety of formats, and with country/regulatory agency-specific requirements in mind.

This course will walk the participants through the country requirements, IND submission requirements, and timelines for approval in Canada, the EU, South Africa, Australia, Asia, and South America using the U.S. IND as the basis for comparison. After the initial IND filings are reviewed, what work will be needed for maintaining the submission and closing the trial will be examined.

Register by June 14 to save up to $200.00
This course provides an excellent introduction to clinical data management in the pharmaceutical industry. Its focus on processes and their rationale renders it ideal for the new data manager and to other individuals who wish to learn basic clinical data management skills and the function of clinical data management in the drug development process.

Register by May 11 to save up to $200.00
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.

Register by May 11 to save up to $200.00
This course will deliver an introduction to the basics of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. This course addresses the regulatory issues across global government agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international safety and reporting standards.

Register by May 11 to save up to $200.00
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.

Register by May 18 to save up to $200.00
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.

Register by May 18 to save up to $200.00
This course provides an in-depth overview of Contract Research Organization (CRO) management, starting with reviewing of bids through follow-up analysis and debriefing of the CRO partnership.

Register by May 18 to save up to $200.00
Designed for non-statisticians, this basic statistical concepts workshop has direct applicability to clinical research. The choice of statistical method, the application of statistical principles, and the interpretation of statistical results are the foundation of the design and analysis of clinical trials. It is therefore critical that statistical methods are fully understood before they are implemented. This course is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Please note that this is not a course on statistical formulas or computations.

Register by May 18 to save up to $200.00
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.

Register by May 18 to save up to $200.00
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.

Register by May 18 to save up to $200.00
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.

Query creation involves the identification of the data anomaly as per protocol requirements, creating a question to be sent to the investigative site for data clarification or data amendment/update. Managing query follow- up is vital to developing reliable data. Once queries have been written it is necessary to ensure appropriate responses are made and to identify when database updates are necessary.

Register by May 18 to save up to $200.00
A gap analysis is an assessment tool to help identify differences between "the space where we are and where we want to be." A gap analysis helps bridge that space by highlighting which requirements are being met and which are not. The tool provides a foundation for measuring the investment of time, money, and human resources that's required to achieve a particular outcome, such as an approved marketing application.

Register by May 15 to save up to $200.00
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.

Register by May 15 to save up to $200.00
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.

Register by May 15 to save up to $200.00
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 infrastructure must often be strengthened, and many achievements taken for granted in the Western research world may pose barriers in resource-limited settings.

Register by May 15 to save up to $200.00
The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the Agency about the proposed development plan, keep the Agency up to date and answer any questions the Agency has about an on-going investigation, request and prepare for meetings with the Agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner.

Submissions to a regulatory agency involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing (IND), and marketing (NDA/CTD) applications. Participants also gain experience with tools that help manage timelines and sections needed from contributors.

Register by May 15 to save up to $200.00
Managing compliance in the research industry is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, correct the non-compliance through intervention, and evaluate the effectiveness of the intervention. Root cause analysis provides a process through which issues can be accurately identified and interventions can be effectively designed. Millions of dollars and countless hours are wasted every year on ineffective interventions because of inaccurate and/or inadequate issues management and root cause analysis. This course will present the concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC.

The corrective action process including, when appropriate, preventive action planning, should be implemented when RCA has been completed. Effective corrective action planning includes many important steps that lead to promoting improved performance for the study and for future activities. Most importantly, effective CAPA can lead to improved human subject protections and confidence in the integrity of the data. Lack of effective corrective action management can lead to repeated non-compliance, compromised subject safety, poor data quality, and/or unacceptable inspection findings with subsequent negative impact on the final submission.

Register by May 15 to save up to $200.00
This course provides attendees with the skills they need to lead their domestic and global clinical trials to optimal performance. Building on basic and intermediate project management concepts, this course provides the experienced clinical professional with tactical information to overcome the most difficult issues encountered. Advanced concepts will be presented, including performance and time management, delay tracking and prevention, ensuring adequate regional patient supply and enrollment interest before beginning a trial, strategies when enrollment is not progressing, and ensuring high quality data on a global scale. 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.