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Why Should You Attend:

Overview: This training course is designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.

TAT 2012 in Amsterdam, The Netherlands, will be the tenth meeting in the series named in full "International Symposium on Targeted Anticancer Therapies". Like all TAT meetings held since 2005, TAT 2012 will be another official ESMO Partnership Meeting. TAT 2012 is  offered by the Amsterdam-based NDDO Education Foundation, and is co-sponsored by the U.S.

If you read FDA warning letters (and you should!), you are aware that the number of citations for failure to correctly complete the required FDA Form 1572 are increasing.  An FDA Form 1572 is required for drug or biologic studies conducted under an IND, whether in the U.S. or abroad. Similarly, medical device trials require a signed agreement from each investigator that contains information similar to that requested in the 1572.