"Clinical Regulation related Compliance trainings delivered by leading experts through webinars. This section contains compliance training affecting Clinical industry in areas - ICH-Compliance, Clinical Statistics, Good Clinical Practice, Clinical Research, Data and Safety Monitoring, Clinical Trials GXP and Clinical Data Management Systems."
This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.
Instructor : Mukesh KumarLiveThursday, May 24, 2012
This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.
Instructor : Ornat katzir LiveThursday, May 31, 2012
This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA.
Instructor : Mukesh KumarLiveThursday, June 7, 2012
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
This webinar will cover essential elements of multi-national medical device clinical trials, help you understand US and non-US regulatory processes for medical device clinical trials and provide practical tips for assuring US market approval for your device.
Instructor : Mukesh KumarLiveTuesday, June 12, 2012
This 90-minute webinar will help you understand what the true costs are for completing a clinical study and the unanticipated costs that may arise. You will learn about costs that a sponsor must include in a budget and costs that a site bears in the conduct of clinical research.
This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.
This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.
This 3-hr 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.
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA (new requirements 2012) compliance.
Kate Borten, CISSP, CISM
Kate Borten, president and founder of The Marblehead Group, Inc. brings to clients a unique combination of expertise in information security, privacy, and IT from over twenty years inside the healthcare industry. She led the first corporate-wide information security program at Massachusetts General Hospital, and she is the former Chief Information Security Officer at CareGroup, a major healthcare system based in Boston.
Ms. Borten is a nationally-recognized expert on HIPAA and health information privacy and security, and a frequent speaker on the topic. She is a contributing author to Auerbach Publications' Information Security Management Handbook; author of HIPAA Security Made Simple (HCPro, Inc. 2003) and Guide to HIPAA Security Risk Analysis (HCPro, Inc. 2004).
