WEBINARS

 

Clinical Research Regulations and Guidance Training - Live Webinars, Recordings & CDs

Compliance with Brexit's Impact on the Global Pharmaceutical industry

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705047

Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.

Recording Available

 

How to prepare a 510(k) FDA Submission

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705024

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.

Recording Available

 

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

 

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

 

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

webinar-speaker   Steven Grossman

webinar-time   90 Min

Product Id: 705023

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

Recording Available

* Per Attendee $199

 

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

 

Russia: Compliance Processes and Regulations

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 703870

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

Recording Available

* Per Attendee $249

 

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

 

Selection and Management of Contract Vendors

webinar-speaker   Peggy Berry

webinar-time   90 Min

Product Id: 704884

This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.

Recording Available

 

Submitting FDA Electronic Regulatory Filings - Drug Establishment Registrations and Drug Listings

webinar-speaker   Camille Davis Thornton

webinar-time   60 Min

Product Id: 703234

This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).

Recording Available

* Per Attendee $249

 

Defining and Managing Protocol Deviation/Violation/Exception

webinar-speaker   Calin Popa

webinar-time   90 Min

Product Id: 704953

This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.

Recording Available

 

Creating Effective SOPs for Regulatory Compliance

webinar-speaker   Henry Urbach

webinar-time   60 Min

Product Id: 702999

This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

Recording Available

* Per Attendee $199

 

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

 

Investigational Review Board and FDA Warning Letters

webinar-speaker   Kesley Tyson

webinar-time   60 Min

Product Id: 704786

This training program will identify regulations and guidelines pertaining to institutional review boards. Attendees will learn about the historical events leading up to today’s regulatory framework in clinical research as well as discuss recent ethical issues regarding the IRB. The course will also explore the emergence of IRBs that are not academically affiliated.

Recording Available

 

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

 

Data Management in Clinical Research

webinar-speaker   Kesley Tyson

webinar-time   60 Min

Product Id: 704768

This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.

Recording Available

 

How to Build Effective Metrics for Vendor Oversight

webinar-speaker   Beat Widler

webinar-time   60 Min

Product Id: 704766

This training program will explain what the critical areas and elements of vendor oversight are and how you can set such a system up for yourself at your company.

Recording Available

* Per Attendee $50

 

Understanding and Applying Best Practice Standards When Reviewing Clinical Research Contracts

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 704337

This training program will take an in-depth look at various clinical research contracts designed for different purposes. Understanding each type including what is being protected and who is being protected is an important part of ensuring compliant administration and management of clinical research activities. Beyond the legal terms, this course will examine the standards for accredited organizations and best practices for ensuring the broadest protections for study participants.

Recording Available

* Per Attendee $249

 

Risk-Based Monitoring Beyond the RACT

webinar-speaker   Beat Widler

webinar-time   60 Min

Product Id: 704721

This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.

Recording Available

 

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

 

 

 

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