12 Fundamental Courses on Clinical Trials - Principles and Best Practices

Get trained on these package training phases of clinical research, Good Clinical Practices, elements of a quality system, ethics in clinical trials and more. Attend this training on clinical supplies and learn what are the steps required for labeling and packaging the supplies for use in a clinical trial, learn the differences between device and drug clinical research and the latest regulations governing the use of drugs and devices in a clinical research, learn how to apply Computer System Validation and System Development Life Cycle Methodologies to computer system validation in support of clinical trial work. Participants will understand the key components of a QMS, key elements of a document management program, critical aspects of a training program, how to prepare clinical site staff for internal and external audits, discuss best practices for an internal audit program. In one of the training programs Dr. Mukesh Kumar shares tips for addressing potential issues related to using social media in the current clinical research landscape. This package will provide practical tips for using social media to approach, educate and recruit clinical trial participants. Sign up to know the clinical evolution, and guidelines of MEDDEV 2.12-2 on post market clinical follow-up and also get trained on the new Regulation EU No 536/2014 and its effects.
Instructor: Meryl Wiernik, Dr. Donald Levine, Sarah Fowler-Dixon, Carolyn Troiano, Dr. Susan Leister, Mukesh Kumar, Thomas A Lang, Daniel O'Leary, Sue Fitzpatrick, Jane Tucker, Adriaan Fruijtier
Product ID: PACK70060

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Business Development
  • Study Coordinators
  • Vendor staff supporting the clinical trials industry
  • R&D Personnel
  • Clinical Supply Scientist
  • Project Managers
  • Clinical Operations
  • CRA
  • Research Staff
  • Auditors
  • Research Administrators
  • Information technology analysts
  • Clinical data managers and scientists
  • Biostatisticians
  • Clinical Study Staff
  • Clinical Quality Staff
  • Monitors
  • Sponsors
  • Regulatory Staff
  • Clinical Study Coordinators
  • Monitors
  • Clinical Trial Support Staff
  • Clinical Project Managers
  • Principle Investigators
  • Compliance Managers
  • Regulatory Vice Presidents, Directors and Managers
  • Attorneys - In-house or Outside Counsel
  • Senior executives of Pharmaceutical and Device Firms
  • Regulatory and Medical Writers
  • Medical Schools and Medical Centers
  • Publishers of Health And Medical Publications
  • Professional Societies (Of Doctors, Nurses, Allied Health Professionals)
  • Disease-Focused Organizations
  • Public Health Departments
  • Copyeditors
  • Health Journalists
  • Quality Managers
  • Regulatory Affairs Managers
  • Risk Managers
  • Management Representatives
  • Design Engineers
  • Notified Body Contacts
  • Project Managers
  • Data Managers
  • Statistical Personnel

Webinars included in the Package:

Basic GCP and Clinical Research Training for Newcomers to the Industry (Including Sales Teams) (Duration: 60 Minutes)

A basic knowledge of GCP and the drug development process is crucial for anyone working within the pharmaceutical industry, as well as for sales staff who are newly selling to this industry.

Objectives of the Presentation:

  • Clinical Trials industry introduction
  • Understanding the drug development process
  • Understanding Good Clinical Practices
  • Elements of a quality system
  • Importance of the regulations
  • Understanding ethics in clinical trials

Instructor Profile:

Meryl Wiernik is a consultant to the biopharma industry in the areas of quality assurance, quality and vendor management, outsourcing, and business process optimization. Previously, she was the VP of QA and Business Excellence for SynteractHCR, a mid-sized global CRO, where she participated in company integration activities, global harmonization, and enhancement of quality processes. During her 19 year tenure at Bristol Myers Squibb, she was instrumental in the conceptualization, implementation, growth, and marketing of the BMS Clinical Laboratory, in support of the phase I unit as well as Phase II-IV trials.

Packaging and Labeling of Clinical Supplies (Duration: 60 Minutes)

The entire gamut of the clinical supply process can be daunting to a novice, and at times, even to the seasoned professional, faced with the need to get investigational drugs to an investigator and ultimately to the patients who will be involved in the clinical trial. Faced with the task, one would begin to ask, "How do I go about getting the job done?" "Where do I start?" "What are the regulations involved?" "What are my options?” Regardless of the size of the company you represent, if you are involved in the clinical supply process in any manner, you need to be versed in the A-B-Cs of clinical packaging, both the types of packaging best suited for the clinical trial as well as the process of filling and GMP documentation required. This is a basic step in the clinical supply process and its completion can affect the project timeline.

Objectives of the Presentation:

Introduction to the basic concepts of clinical packaging and labeling and to provide an understanding of the complexities of the work required to prepare investigational materials for clinical trials.

Instructor Profile:

Dr. Donald Levine, D.Ph. is the Founder and President of DJL Pharma Consultants. Prior to this role, Dr. Levine was employed at Plough, Inc., Schering-Plough, Merck Consumer Care for 40 years and retired as Lead, Global Clinical Supply. Approximately 2/3 of his career was spent in Clinical Research and Operations, Product Safety, and Clinical Supply supporting three diverse business groups: skincare, foot care and oral dosage forms. As a result, he has first-hand knowledge and experience in clinical development and clinical supplies as it pertains to the IND/NDA studies, Rx-to-OTC switch programs, claim support studies, and project management.

Differences between Device and Drug Clinical Research - A Jeopardy Learning Game (Duration: 60 Minutes)

This webinar will discuss the differences between device and drug clinical research and the current regulations governing the use of drugs and devices in a clinical study. Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well as current guidance affecting the classification of devices.

Objectives of the Presentation:

  • Define drug research
  • Define device research
  • Explore the differences between the two
  • Describe requirements when drugs and devices are combined in one study

Instructor Profile:

Sarah Fowler-Dixon, PhD, CIP is an Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.

Computer System Validation for Systems Supporting Clinical Trials (Duration: 60 Minutes)

You should attend this webinar if you are responsible for planning, executing or managing the implementation of a computer system that is used to support clinical trial work and is governed by FDA regulations, or if you are maintaining or supporting such a system.

Objectives of the Presentation:

  • Upon completion of this session, attendees will have an understanding of how to apply the CSV and SDLC methodologies to computer system validation in support of clinical trial work, and develop a sound strategy for meeting FDA compliance, both one-time and on an ongoing basis.
  • The attendees will understand the level of effort required for executing each phase of the CSV/SDLC approach, and the appropriate level of documentation that must be completed to support it. They will also gain an understanding of the training and skills required to apply the CSV/SDLC approach to clinical trial systems when validating or maintaining them.
  • The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for applying the SDLC to systems in accordance with FDA requirements.

Instructor Profile:

Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Clinical Trial Site Quality Management System (Duration: 120 Minutes)

Attending this session will help one gain additional quality skills and tools which can improve your overall site performance. This session will help a clinical site build a stronger Quality Management System by eliminating potential weaknesses within their quality programs. Having a well-organized and effective QMS helps the site be inspection ready for the various regulatory audits that may come their way. This webinar reviews the critical elements of the QMS and discuss challenges, best practices, and things to consider to help clinical staff develop or improve their system.

Objectives of the Presentation:

  • Discuss the key components of a QMS
  • Discuss the key elements of a document management program
  • Discuss the critical aspects of a training program
  • Discuss the key elements of an audit program
  • Discuss the key components of a CAPA program
  • Discuss the critical aspects of root cause analysis

Instructor Profile:

Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 20 years of experience in the pharmaceutical and medical device industry. She has validated over 40 software systems in the past few years and is very fluent in software validation requirements and compliance. She serves the ASQ Section 509 Executive Committee as the chair-elect and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.

Audit program (Internal & External ) for Clinical trial sites (Duration: 120 Minutes)

Audits can be unpredictable, especially external audits. This is the benefit of having an internal audit program. We will review best practices for an internal audit program and how to prepare for internal audits. In addition, we will discuss how to manage external audits. It is better to prepare then be surprised when the audit request occurs. Take the time now to plan and prepare while educating all of your staff on audit do's and don'ts. Lack of preparation can result in an unfavorable outcome.

Objectives of the Presentation:

  • Review the overall purpose of auditing for clinical trials
  • Discuss internal audit program for clinical sites
  • Discuss how to manage internal audits
  • Discuss how to manage external audits (sponsor/client)
  • Discuss how to manage regulatory inspections
  • Discuss inspection readiness approach

Instructor Profile:

Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 20 years of experience in the pharmaceutical and medical device industry. She has validated over 40 software systems in the past few years and is very fluent in software validation requirements and compliance. She serves the ASQ Section 509 Executive Committee as the chair-elect and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.

Social Media and Clinical Trials: Patient-Physician Interactions, Patient-Patient Interactions (Duration: 60 Minutes)

This webinar will discuss numerous ways in which social media led patient-patient, patient-investigators, investigator-sponsor, and sponsor-patient interactions and data-mining can be conducted for a better, efficient and productive clinical trial. There are also concerns about maintaining trial integrity, logistical affability, and financial feasibility of using social media in clinical trials. FDA rules and industry practices will be discussed in light of the technological challenges with using social media in clinical trials.

Objectives of the Presentation:

  • Best practices for using social media for patient-investigator interactions
  • Issues related to patient-patient interactions such as "Patientslikeme"
  • Common ways companies are currently using social media in clinical trials
  • FDA rules for using social media in clinical trials
  • Crowd-sourcing, Wiki-creating, data-mining, and other social media practices for clinical trials
  • Recent trends in FDA enforcement actions involving social media

Instructor Profile:

Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Social Media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced (Duration: 60 Minutes)

This webinar will provide tips for using social media in an effective and compliant manner to approach, educate and select clinical trial participants. Also discussed will be comparison between social media and other strategies such as data mining, electronic medical record searches to match patients with trials, and working with patient advocacy groups. The presentation will also provide tested strategies to implement a strong social media campaign for trial recruitment that is focused on patient trust building and conversion.

Objectives of the Presentation:

  • Social media recruitment strategy
  • Regulatory approval of social media recruitment portals
  • Analyzing effectiveness of social media recruitment tools
  • Cultural, generational and technical challenges and solutions
  • Generating social media visibility
  • Social media messaging: best practices
  • Pros and cons of various social media outlets
  • Trends of social media usage and troubleshooting

Instructor Profile:

Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Avoiding 12 Common Statistical Errors in Clinical Research (Duration: 60 Minutes)

Anyone who reads the medical literature needs to be able to evaluate the quality of the research they read. This webinar introduces participants to the topic of "critical appraisal" in medical research, or the ability to evaluate research designs and activities and statistical methods and analysis commonly used in medical research.

Objectives of the Presentation:

  • Be able to describe the nature and extent of poor statistical reporting in the clinical literature
  • Be able to list at least 2 common errors in reporting numbers
  • Be able to list at least 2 common errors in reporting descriptive statistics
  • Be able to list at least 2 common errors in reporting regression analyses
  • Be able to list at least 2 common errors in reporting risk
  • Be able to list at least 2 common errors in reporting P values

Instructor Profile:

Thomas A Lang, MA, is an international consultant and trainer in medical communications. Formerly Manager of Medical Editing Services at the Cleveland Clinic, he has long been involved in developing reporting standards for evidence-based medicine, including the CONSORT and PRISMA groups. His books, How to Report Statistics in Medicine and How to Write, Publish, and Present in the Health Sciences are standard references in medical writing.

Clinical Evaluation and Risk Management (Duration: 90 Minutes)

In developing, manufacturing, and providing medical devices, Risk Management is an important aspect. In the EU, Risk Management utilizes the harmonized standard EN ISO 14971:2012. Based on ISO 14972:2007, Risk Management includes collecting and evaluating post-production information. If post-production information reveals unrecognized hazards, unrecognized hazardous situations, or risk estimates that are no longer acceptable, then the manufacturer should re-examine the risk file and the associated decisions. Clearly, much of the post-production information will update the clinical evaluation as well as the Risk Management file. The webinar develops the requirements and provides an integrated approach.

Objectives of the Presentation:

  • Learn the requirements from the MDD
  • Understand the MEDDEV guidance documents and how to use them
  • Learn the requirements from EN ISO 14971:2012
  • Understand role of the Risk Management Plan
  • Link the sets of requirements to provide an efficient and comprehensive process

Instructor Profile:

Daniel O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial Quality (Duration: 90 Minutes)

Any clinical research professional embarking on a risk based approach would benefit from attending this course. In order for a risk based approach to operate effectively all clinical trial disciplines e.g. monitors, CRAs, data management, project management statisticians, outsourcing, drug suppliers etc, should provide their unique input to all steps in the process.

Objectives of the Presentation:

By the end of this course you will be able to:
  • Review the basic principles of Risk Management
  • Utilize the basic principles to take a 'risk-based approach'
  • Document risks identified
  • Prioritize risks and plan mitigation actions where necessary
  • Outline the limitations of current monitoring practices
  • Differentiate between different types of monitoring
  • Describe the link between study level risk assessment and the monitoring plan
  • Identify risk triggers during monitoring
  • Share best practice

Instructor Profile:

Sue Fitzpatrick has more than 30 years' Pharmaceutical Industry experience. She has been responsible for the management and audit of CRAs, CROs and clinical trials in a wide range of therapeutic areas.
Jane Tucker Risk Management Trainer and consultant, Sue Fitzpatrick Associates. Over the past 30+ years Jane has moved from routine data cleaning activities, via system validation on to training and data quality activities, eventually specializing, within her role as a Quality Risk Manager, in Risk Assessment and Management.

Ready for the change? Guidance on new EU Clinical Trial Regulation (EU-CTR) (Duration: 90 Minutes)

It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval. In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol. In the Webinar it will be explained how in the new procedure this problem will be avoided. The Webinar will also discuss important changes with regard to the protection of subjects and give a detailed overview of the new procedure. A detailed knowledge of the new procedure is key to personnel responsible for clinical trial training and applications.

Objectives of the Presentation:

Knowledge of the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials, the 'Clinical Trials Regulation', and its impact for the industry on medicinal products for human use.

Instructor Profile:

Adriaan Fruijtier graduated as a pharmacist from the University of Utrecht, Netherlands. Until March 2004, he headed the oncology group within global regulatory affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was director of regulatory affairs at Micromet AG, a biotech company in Munich, Germany.

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