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Live Webinar Clinical Trials in US, Europe and Canada Date: Thu, December 11, 2014 Instructor:Anne Tomalin
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
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Location: Online
Overview: This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Areas covered in the session: Regulatory requirements for Phase I-3 clinical trials to gain approval to conduct the trial Process for approval, when pre-IND meetings or Scientific Advice meetings are useful. Handling changes to protocols or clinical trial supplies. How adverse reactions are handled, including the development of Development Safety Update Reports. How registries fit into the picture. Data that must be made public. How are premature discontinuations of clinical trials handled Requirement if a Regulatory Agency refuses a clinical trial Requirement if an Ethics Board refuses a clinical trial.
Who Will Benefit: Director of Clinical Research Manager of Clinical Research Coordinator of Clinical Research Director of Regulatory Affairs Manager of Regulatory Affairs Manager of Medical Affairs
About Speaker Anne Tomalin President, Therapeutic Products Inc. Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies. Anne is a graduate of York University, and
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