Webinar
Enhanced Monitoring Tools and Strategies that Optimize Productivity and Compliance
This webinar will discuss the issues surrounding monitoring performance in US-based pre-market studies and provide enhanced techniques that optimize productivity without compromising subject safety and quality data, and review techniques that supersede basic training and enhance clinical monitoring efficiency in US- based premarket trials.

9/15/2010

Webinar
Regulatory Compliance in UK Laboratories Processing Clinical Trial Samples: Guidance from a UK Regulatory Inspector
This webinar will provide a rare opportunity to discuss your queries of Laboratory Compliance directly with Andrew Gray, Head of the United Kingdom Good Laboratory Monitoring Authority within the UK Regulatory Inspectorate Group of the MHRA (Medicines and Healthcare Product’s Regulatory Agency).

9/29/2010

Classroom Course
Fundamentals of Clinical Research - San Francisco, California
This newly revised and expanded two-day course provides the core knowledge and skills that clinical research professionals who have up to 18 months practical experience in clinical trials need in order to better execute their functions.

09/30/10-10/01/10

Webinar
Online Maintenance Made Easy
This webinar has been designed to take the frustration out of maintaining ACRP credentials. The program requirements will be thoroughly discussed. This will include how many hours/points must be completed, fees, what types of courses are acceptable and how to determine if it would fall into the clinical research or therapeutic category, continuing involvement versus continuing education.

10/06/10

Classroom Course
Fundamentals of Clinical Research - Houston, Texas
This newly revised and expanded two-day course provides the core knowledge and skills that clinical research professionals who have up to 18 months practical experience in clinical trials need in order to better execute their functions.

10/07/10-10/08/10

Webinar
UK Regulatory Authority Inspector Discusses Compliance Issues of Sponsor’s Responsibilities
ACRP (UK Office) is working closely with the UK Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) inspectorate group to deliver 4 educational webinars on areas of concern particularly at Investigator Sites. The Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Enforcement & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation and takes enforcement action where necessary. This is the third webinar, and Gail Francis (Expert Inspector, GCP, MHRA) will discuss the sponsorship issues from the results of the inspection findings of their UK Good Clinical Practice Inspections. Please note the findings cover UK site inspections only.

10/20/10

Classroom Course
Project Management - Alexandria, Virginia
This two-day seminar, worth 12 contact hours, provides an overview of the different project management approaches used by Sponsors and Contract Research Organizations, and helps you decide how to apply them in your situation.

10/21/10-10/22/10

Webinar
Practical Pharmacovigilance for Clinical Trials: Guidance from a UK Regulatory Inspector
ACRP (UK Office) is working closely with the UK Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) inspectorate group to deliver 4 educational webinars on areas of concern particularly at Investigator Sites. The Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Enforcement & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation and takes enforcement action where necessary. This is the fourth webinar and Patricia Moore (Senior Pharmacovigilance Inspector, MHRA) will discuss the pharmacovigilance requirements in place within the UK for clinical trials and provide guidance on the ways in which Sponsors may work to meet these requirements.

11/03/10

Classroom Course
Fundamentals of Clinical Research - Alexandria, Virginia
This newly revised and expanded two-day course provides the core knowledge and skills that clinical research professionals who have up to 18 months practical experience in clinical trials need in order to better execute their functions.

11/04/10-11/05/10

Webinar
Major Trends Affecting Clinical Research in the Next Three to Five Years
A handful of major trends within the industry and outside of the industry will have an impact on how clinical research is conducted and managed. This session covers some of these major trends and their expected impact.

11/10/10

Webinar
New Ethical Guidelines for Conducting Pediatric Research
This program will cover the new AAP Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations.

12/01/10

Webinar
Guidelines for Effective and Appropriate Pediatric Assent and Parental Permission
This webinar describes methods that individuals involved with pediatric research can use to become more aware of regulatory recommendations regarding pediatric risk categories and required parental signatures, to develop or approve more effective and age-appropriate assent forms, and to conduct and document the assenting process.

12/08/10

Webinar
Seven Mistakes Commonly Made During a Monitoring Visit
Monitors play a crucial role in the successful completion of a clinical trial and are often the only liaison between the Sponsor and the site. Several FDA warning letters have been recently issued that document the inadequate monitoring practices in the industry. It is critical for monitors to be armed with the appropriate knowledge and training to adequately and successfully conduct their monitoring visits. This session will cover the top seven mistakes commonly made by the monitor during a monitoring visit and how to avoid them.

12/15/10