ComplianceOnline

Clinical Research Outsourcing Regulatory Compliance Training - Live Webinars, Recordings & CDs

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
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

  • Speaker: Rossano V Gerald
  • Product ID: 705186
  • Duration: 60 Min
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
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
Compliance with the New ICH GCP revised 2 Guidelines

Compliance with the New ICH GCP revised 2 Guidelines

  • Speaker: Laura Brown
  • Product ID: 704989
  • Duration: 60 Min
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.
Recorded/CD
Russia: Compliance Processes and Regulations

Russia: Compliance Processes and Regulations

  • Speaker: Robert J Russell
  • Product ID: 703870
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
The New EU Clinical Trial Regulation

The New EU Clinical Trial Regulation

  • Speaker: Robert J Russell
  • Product ID: 703758
  • Duration: 90 Min
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.
CD/Recorded
$279
Recorded/CD
How to Build Effective Metrics for Vendor Oversight

How to Build Effective Metrics for Vendor Oversight

  • Speaker: Beat Widler
  • Product ID: 704766
  • Duration: 60 Min
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.
CD/Recorded
$25
Recorded/CD
FDA vs. EU Inspections - Getting Prepared and What are Differences

FDA vs. EU Inspections - Getting Prepared and What are Differences

  • Speaker: Marie Dorat
  • Product ID: 703516
  • Duration: 75 Min
This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
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
The New European Union Clinical Trials Regulation:  An Analysis of the Key Changes and their Implications for Future Clinical Trials

The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials

  • Speaker: Ciara Farrell,Elisabethann Wright
  • Product ID: 703445
  • Duration: 60 Min
This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.
CD/Recorded
$229
Recorded/CD
Walking the Minefield of Clinical Trial Budgets and Contracts; A Primer for Research Managers

Walking the Minefield of Clinical Trial Budgets and Contracts; A Primer for Research Managers

  • Speaker: Robert Romanchuk
  • Product ID: 702373
  • Duration: 90 Min
This webinar will provide a basic understanding of regulations and statutes that people involved in the clinical research contract negotiation process must be aware of. You will learn how to negotiate for and create federally complaint agreements and thus avoid the risk associated with violations.
CD/Recorded
$229
Recorded/CD
2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

  • Speaker: John E Lincoln
  • Product ID: 703052
  • Duration: 3.5 hrs
This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.
CD/Recorded
$499
Recorded/CD
Global Medical Device Laws and Regulations: US, EU, and Canada

Global Medical Device Laws and Regulations: US, EU, and Canada

  • Speaker: David Lim
  • Product ID: 702842
  • Duration: 90 Min
This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.
CD/Recorded
$25
Recorded/CD
Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

  • Speaker: David Lim
  • Product ID: 702841
  • Duration: 90 Min
This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.
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
Recorded/CD
The 2010 FDA warning letters: Revealing the critical conduct areas in clinical studies

The 2010 FDA warning letters: Revealing the critical conduct areas in clinical studies

  • Speaker: Leonidas Lambrinidis
  • Product ID: 702073
  • Duration: 90 Min
This 90-minute webinar will review FDA warning letters in Clinical Trials and present critical parameters to watch out for in order to secure compliance whether you are running or monitoring a clinical trial.
CD/Recorded
$25
Recorded/CD
Outsourcing Clinical Trials in Latin America

Outsourcing Clinical Trials in Latin America

  • Speaker: Tatiana Vogel
  • Product ID: 701690
  • Duration: 42 Min
This clinical trial training will review some Outsourcing Models that have been used successfully in the Latin American countries where Clinical Research is developed, identifying best practices and opportunities that speed protocol approval in these countries.
CD/Recorded
$249
Recorded/CD
Orchestrating the Integration of Multiple Technical Suppliers in a Clinical Trial

Orchestrating the Integration of Multiple Technical Suppliers in a Clinical Trial

  • Speaker: Richard Barrett
  • Product ID: 700277
  • Duration: 60 Min
In this presentation we use the orchestra as an example of how multiple technical suppliers can work successfully together, how outcomes can be measured, and its direct application to clinical trials
CD/Recorded
$249
Best Sellers
You Recently Viewed
    Loading