Presented by Modoc Research Services and Nuventra Pharma Sciences

Please join us for free lunch and a discussion about the effects of new data integrity guidelines on business activities. This discussion will include ICH E6 R2, the April 2016 FDA Draft Guidance, the July 2016 MHRA Draft Guidance, the August 2016 PIC/S Draft Guidance, and the August 2016 EMA Questions and Answers related to Data Integrity. Presenter Mary Roach will begin by discussing data integrity requirements, transferring data between vendors/CROs/sponsors, and implementation of recent guideline requirements. Presenter Jessica Higgins will then provide real-world examples of handling data through a Programmer’s hands-on perspective. Lastly, Presenter Deb Fontana will then discuss data integrity requirements as part of an efficient computer system validation process.