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.
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.
Robert J Russell
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.
Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research
Sarah Fowler Dixon
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.
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.
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.
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.
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.
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.
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?
William Mack Copeland
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.
The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?
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.
Anne E Maczulak
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.
FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application
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.
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.
Designing a Pediatric Clinical Trial - ethical consideration and how to manage per regulatory requirements
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.