ComplianceOnline

Clinical Research Roles and Responsibilities Regulatory Compliance Training - Live Webinars, Recordings & CDs

Recorded/CD
Annual Current Good Clinical Practices (cGCP) Training

Annual Current Good Clinical Practices (cGCP) Training

  • Speaker: Shana Dressel
  • Product ID: 705408
  • Duration: 60 Min
This webinar will cover background information and history of clinical research and drug development, followed by review of the federal regulations, International Council for Harmonisation (ICH), and Good Clinical Practices (GCP) that apply to clinical research.
CD/Recorded
$249
Recorded/CD
China Regulatory Compliance for Life Science products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

China Regulatory Compliance for Life Science products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

  • Speaker: Robert J Russell
  • Product ID: 702037
  • Duration: 90 Min
This 90-minute China life science compliance based webinar will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
CD/Recorded
$249
Recorded/CD
Risk Based Monitoring for GCP Compliance

Risk Based Monitoring for GCP Compliance

  • Speaker: Laura Brown
  • Product ID: 705052
  • Duration: 60 Min
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
CD/Recorded
$249
Recorded/CD
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

  • Speaker: Rachelle D Souza
  • Product ID: 704906
  • Duration: 60 Min
This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.
CD/Recorded
$249
Recorded/CD
Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

  • Speaker: Charles H Pierce
  • Product ID: 704842
  • Duration: 90 Min
This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.
CD/Recorded
$25
Recorded/CD
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

  • Speaker: Jennifer Holcomb
  • Product ID: 702406
  • Duration: 60 Min
This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.
CD/Recorded
$249
Recorded/CD
When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

  • Speaker: Jennifer Holcomb
  • Product ID: 702345
  • Duration: 60 Min
This Clinical compliance training will review the purpose of INDs and the process for obtaining an IND. Attendees will gain a complete understanding of the criteria for exemption and the impact an exemption has on a study.
CD/Recorded
$229
Recorded/CD
Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

  • Speaker: Jennifer Holcomb
  • Product ID: 704289
  • Duration: 60 Min
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.
CD/Recorded
$229
Recorded/CD
CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

  • Speaker: Sunil Gupta
  • Product ID: 704674
  • Duration: 75 Min
This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.
Recorded/CD
What are Serious Adverse Events and How do I Handle These?

What are Serious Adverse Events and How do I Handle These?

  • Speaker: Sarah Fowler Dixon
  • Product ID: 702407
  • Duration: 60 Min
This webinar will make a distinction between nomenclatures (serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems) and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).
CD/Recorded
$249
Recorded/CD
Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

  • Speaker: Nicole Tesar
  • Product ID: 704534
  • Duration: 60 Min
This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.
Recorded/CD
Latest Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally

Latest Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally

  • Speaker: Laura Brown
  • Product ID: 701947
  • Duration: 60 Min
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
CD/Recorded
$229
Recorded/CD
Superiority, Non-inferiority, or Equivalence Trials: How, Why and When

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

  • Speaker: Rita Hanover
  • Product ID: 702591
  • Duration: 60 Min
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.
CD/Recorded
$229
Recorded/CD
South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam

South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam

  • Speaker: Robert J Russell
  • Product ID: 702546
  • Duration: 90 Min
This training on South East Asia regulatory compliance for life science products will discuss the regulatory structure and requirements for compliance with in-country regulations for pharmaceuticals, medical devices, biologics and combination products. This webinar will focus on a high-level composite of requirements in Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand.
CD/Recorded
$229
Recorded/CD
Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

  • Speaker: Laura Brown
  • Product ID: 703695
  • Duration: 60 Min
This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.
CD/Recorded
$229
Recorded/CD
Ensuring Legally-Effective Informed Consent:  Basic to Advanced Issues for Investigators and IRBs

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

  • Speaker: George Gasparis
  • Product ID: 703562
  • Duration: 90 Min
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.
CD/Recorded
$229
Recorded/CD
The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

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

  • Speaker: Stephen Schwartz
  • Product ID: 702538
  • Duration: 75 Min
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.
CD/Recorded
$229
Recorded/CD
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

  • Speaker: David Lim
  • Product ID: 702252
  • Duration: 90 Min
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
CD/Recorded
$229
Recorded/CD
Audit/Inspection Preparedness for Clinical Research/Site Coordinators

Audit/Inspection Preparedness for Clinical Research/Site Coordinators

  • Speaker: Ornat katzir
  • Product ID: 702248
  • Duration: 60 Min
This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.
CD/Recorded
$229
Recorded/CD
CRO or ARO: How to Hire and Manage One

CRO or ARO: How to Hire and Manage One

  • Speaker: Ethel Kagan, R.N., B.A.
  • Product ID: 702232
  • Duration: 60 Min
This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted.
CD/Recorded
$25
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