2-day In-person Seminar (June 25-26, 2015)
eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
On 5th May, 2015, the FDA issued its final guidance on electronic submissions. Speaker, Dr. Mukesh Kumar, PhD RAC (VP, Regulatory Affairs and Quality Assurance) in this workshop will go over the details of the latest guidance and explain the key takeaways.
Soon FDA will stop accepting paper submissions of all kinds of applications. Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.
This 2-day workshop is designed to address all these and provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Who Will Benefit:
For additional information on the workshop agenda and logistics, please call +1 410-501-5777 or email: email@example.com