BethAri Presents CTD & Dossier Evaluation Training to NAFDAC, July 2013 - 05 Jul 2013
BethAri consultants recently concluded an intense 3 day dossier evaluation / assessment training to senior staff and Establishment Inspectors within the Drug Evaluation & Research Department of the National Agency for Food Drug Administration Control (NAFDAC) in July 2013. The 3 day interactive session took place in Abuja, Nigeria between 2 and 4th July. The course content focused on the CTD and quality aspects in the assessment of a generic product dossier (APIs and FPPs) as submitted to NAFDAC. The course also covered subject areas as bioequivalence issues and bio-waivers, analytical methods, stability assessment considerations as well as product information and labeling considerations.
As part of the training, further interactive sessions on GMP Inspection planning, Deficiency Classifications and Site Master File were presented on the final day. All participants had written examination assessment on the training topics which provided them an opportunity to re-enforce their learning’s from the course.