WEBINARS

 

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

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

 

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

webinar-speaker   Rossano V Gerald

webinar-time   60 Min

Product Id: 705186

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.

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 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

 

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

 

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

 

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

webinar-speaker   Marie Dorat

webinar-time   75 Min

Product Id: 703516

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.

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

 

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

webinar-speaker   Ciara Farrell,Elisabethann Wright

webinar-time   60 Min

Product Id: 703445

This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Robert Romanchuk

webinar-time   90 Min

Product Id: 702373

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   John E Lincoln

webinar-time   3.5 hrs

Product Id: 703052

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.

Recording Available

* Per Attendee $499

 

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

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702842

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.

Recording Available

* Per Attendee $50

 

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

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702841

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.

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

 

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

webinar-speaker   Leonidas Lambrinidis

webinar-time   90 Min

Product Id: 702073

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.

Recording Available

* Per Attendee $50

 

Outsourcing Clinical Trials in Latin America

webinar-speaker   Tatiana Vogel

webinar-time   42 Min

Product Id: 701690

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.

Recording Available

* Per Attendee $249

 

Orchestrating the Integration of Multiple Technical Suppliers in a Clinical Trial

webinar-speaker   Richard Barrett

webinar-time   60 Min

Product Id: 700277

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

Recording Available

* Per Attendee $249

 

 

 

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