China Regulatory Compliance for Life Science products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
Robert J Russell
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.
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries
Rossano V Gerald
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.
Charles H Pierce
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.
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.
Robert J Russell
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.
Robert J Russell
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.
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.
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.
South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam
Robert J Russell
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.
The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials
Ciara Farrell,Elisabethann Wright
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.
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.
John E Lincoln
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.
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.
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.
Ethel Kagan, R.N., B.A.
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.
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.
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.