CenterWatch

Training Programs

To have your training program included, please contact jobwatch@centerwatch.com.

September

September 1-30, 2017

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

September 26-27, 2017

Monitoring Clinical Drug Studies: Advanced
Philadelphia, PA

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 $1,675.00 price by registering early!* After December 22, costs are $1,875.00.

September 26-27, 2017

Writing Clinical Evaluation Reports
San Francisco, CA

This course will include a review of the Medical Devices (MEDDEV) 2.7.1, Rev 4 guideline issued in June 2016 and a discussion of the Therapeutic Goods Administration (TGA) guideline. In this interactive program, participants will also have the opportunity to share their experiences with Clinical Evaluation Reports (CERs) in general. All devices are required to have a CER for products marketed in the EU and globally. This course will explore good writing skills and techniques needed to create a CER and to respond to reviewer comments.

October

October 1-31, 2017

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

October 3-4, 2017

Pharmacokinetics: A Comprehensive Overview of Principles and Applications
Philadelphia, PA

The course will provide participants with a comprehensive overview of pharmacokinetics by integrating concepts in physiology and mathematics. At the end of this seminar, attendees will understand fundamental pharmacokinetic concepts and be able to use them to design pharmacokinetic studies, compute pharmacokinetic parameters, and predict the effect of physiological and formulation changes on the pharmacokinetics of drugs. The instructor will provide an overview of the anatomy and physiology of organ systems relevant to drug absorption, distribution, metabolism, and excretion, explain pharmacokinetic concepts, demonstrate computation of pharmacokinetic parameters after intravenous and oral doses, and highlight concepts in bioavailability, bioequivalence, and biopharmaceutics. Understanding of theoretical principles will be facilitated by numerous practical examples from the literature, and through case studies. Periodic review and reinforcement of important concepts will be achieved through discussions, and completion of a series of in-class assignments.

October 5, 2017

Pharmacokinetics: 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 E6, 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.

October 10-11, 2017

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance
San Diego, CA

This course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across US and EU 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.

October 16-17, 2017

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.

October 23-25, 2017

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.

October 24-25, 2017

The Future of Clinical Trial Conduct Demands a Quality System Approach: Will You be Ready?
Philadelphia, PA

The future of clinical trial conduct demands a Quality System approach. Recently, regulators have been recommending that a quality system approach be used for the design, development, and execution of clinical studies. Newly released FDA guidances speak on the need to conduct clinical trials using such an approach, but provide little in the way of direction on how to accomplish this. Risk management is an integral component of a quality system approach, and many researchers do not have the knowledge or experience to conduct clinical trial risk management. This course will apply practical approaches and demonstrate associated tools and skills to assist the participant in using a quality system approach within the clinical trial arena from both the site and sponsor perspective

October 26, 2017

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.

November

November 1-15, 2017

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

November 1-2, 2017

Mindfulness for the Clinical Research Professional
Philadelphia, PA

Simply put, mindfulness is paying attention in the moment to thoughts and actions. Mindfulness increases productivity, enhances leadership effectiveness and supports happiness. It also helps leaders to meet adaptive challenges resulting from constant change. This highly interactive course teaches clinical research professionals how to employ mindfulness in their day-to-day work, how to make the connection between mindfulness and emotional intelligence, and tips on reducing stress and improving performance for themselves and their teams in high stress clinical research environments.

Take advantage of our $1,675.00 price by registering early! * After November 3, costs are $1,875.00.

November 7-8, 2017

Introduction to Clinical Research
San Diego, CA

This two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable. Then we will look at the process of drug and device development from discovery to approval. We will introduce you to the protocol which is the blue print for any clinical trial and explain what an informed consent is and why it is so important. In addition to these key trial documents, we will also review other important documents that are used in clinical trials. Finally, we will provide you with resources that will enable you to stay informed about topics and regulations regarding clinical trials in the U.S. and in the European Union.

Take advantage of our $1,675.00 price by registering early!* After October 5, costs are $1,875.00.

November 14-15, 2017

Monitoring Clinical Drug Studies: Advanced
San Diego, CA

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

Take advantage of our $1,675.00 price by registering early!* After Ocatober 12, costs are $1,875.00.

November 20-21, 2017

Clinical Project Management: Intermediate
San Diego, CA

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

Take advantage of our $1,675.00 price by registering early!* After October 18, costs are $1,875.00.

November 28-29, 2017

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 $1,675.00 price by registering early!* After October 27, costs are $1,875.00.