WEBINARS

 

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

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 701947

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.

Recording Available

* Per Attendee $299

 

Risk Based Monitoring for GCP Compliance

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705052

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.

Recording Available

* Per Attendee $299

 

Annual Current Good Clinical Practices (cGCP) Training

webinar-speaker   Shana Dressel

webinar-time   60 Min

Product Id: 705408

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702037

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Rachelle D Souza

webinar-time   60 Min

Product Id: 704906

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Charles H Pierce

webinar-time   90 Min

Product Id: 704842

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.

Recording Available

* Per Attendee $50

 

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

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 702406

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 702345

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.

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

 

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

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704674

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.

Recording Available

 

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

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 702407

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).

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Nicole Tesar

webinar-time   60 Min

Product Id: 704534

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.

Recording Available

 

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

 

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

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702546

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 703695

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.

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

 

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

 

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

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702252

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.

Recording Available

* Per Attendee $229

 

Audit/Inspection Preparedness for Clinical Research/Site Coordinators

webinar-speaker   Ornat katzir

webinar-time   60 Min

Product Id: 702248

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.

Recording Available

* Per Attendee $229

 

CRO or ARO: How to Hire and Manage One

webinar-speaker   Ethel Kagan, R.N., B.A.

webinar-time   60 Min

Product Id: 702232

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.

Recording Available

* Per Attendee $50

 

 

 

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