Category Archives: Webinars

Free Educational Webinar – Critical Steps in PET Radiopharmaceutical Development and Updated FDA Regulations

Update – the slides are available for download here. Presentation Details: In the vast changing world of drug research, it is essential to be well informed about new technological developments and changes in regulations. Recently, there have been new developments … Continue reading

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Updated: Free Educational Webinar – Regulatory Electronic Submissions: eCTD v4 Background and Drivers

The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at … Continue reading

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Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET. Continue reading

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Free Educational Webinar – Reasons to Switch to eCTD

UPDATE: The webinar slides are now available for download here (PDF). The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD … Continue reading

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Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?

UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading

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