WEBINARS

 

Clinical Research Ethics, Fraud and Misconduct Regulatory Compliance Training - Live Webinars, Recordings & CDs

Compliance with the New EU Clinical Trial Regulation

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705007

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

Recording Available

 

Compliance with the New ICH GCP revised 2 Guidelines

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 704989

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

Recording Available

 

The New EU Clinical Trial Regulation

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 703758

This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.

Recording Available

* Per Attendee $279

 

Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 703400

This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.

Recording Available

* Per Attendee $229

 

Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 704289

At the end of this training program, participants will be able to differentiate between consent and assent, identify when to use the long form and when to use the short form, describe the consent process using best practices.

Recording Available

* Per Attendee $229

 

Superiority, Non-inferiority, or Equivalence Trials: How, Why and When

webinar-speaker   Rita Hanover

webinar-time   60 Min

Product Id: 702591

This webinar on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs.

Recording Available

* Per Attendee $229

 

Fraud in Clinical Research

webinar-speaker   David Lim

webinar-time   60 Min

Product Id: 703899

This training program will instruct attendees to better understand ethical and legal requirements when conducting medical/clinical research and study. The webinar will focus on what/how to identify, address and prevent fraud in medical research.

Recording Available

* Per Attendee $229

 

Clinical Trial Liability Lawsuits

webinar-speaker   Jonathan Mcdermed

webinar-time   60 Min

Product Id: 703645

This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.

Recording Available

* Per Attendee $229

 

Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

webinar-speaker   George Gasparis

webinar-time   90 Min

Product Id: 703562

This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.

Recording Available

* Per Attendee $229

 

3-hr Virtual Seminar - The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (FCA): Is your Organization at Risk?

webinar-speaker   William Mack Copeland

webinar-time   3 hrs

Product Id: 702787

This healthcare compliance training will explain how the FCA, the AKS and the Federal Physician Self Referral Law (Stark II) work, the prohibitions, exceptions and safe harbors. It will review recent examples to show how they interface and can potentially impact you/ your organization.

Recording Available

* Per Attendee $399

 

The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

webinar-speaker   Stephen Schwartz

webinar-time   75 Min

Product Id: 702538

This webinar will discuss the role of the ethics committee, the trial sponsor and investigator in providing an adequate Informed Consent (IC). It will discuss challenges and practical limitations in ensuring your informed consent is GCP compliant.

Recording Available

* Per Attendee $229

 

Ethics and Scientific Misconduct in Regulated Studies

webinar-speaker   Anne E Maczulak

webinar-time   60 Min

Product Id: 702343

This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.

Recording Available

* Per Attendee $229

 

FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application

webinar-speaker   Mukesh Kumar

webinar-time   60 Min

Product Id: 702253

This Webinar will help you understand the current FDA requirements regarding financial disclosure in clinical trials. It will discuss differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.

Recording Available

* Per Attendee $229

 

The ICF Process: Tips on Achieving Optimal compliance and Comprehension

webinar-speaker   Kimberly Kiner

webinar-time   44 Min

Product Id: 701686

This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being.

Recording Available

* Per Attendee $50

 

Designing a Pediatric Clinical Trial - ethical consideration and how to manage per regulatory requirements

webinar-speaker   Carol Owen

webinar-time   60 Min

Product Id: 701510

This Pediatric Clinical Trial Design training explains the regulatory requirements for conducting clinical research in the pediatric population, the ethical considerations around the development of pediatric trials, and the challenges of research in this vulnerable population.

Recording Available

* Per Attendee $249

 

 

 

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