Breaking Regulatory Update for Life Science Firms – UFA Requirements for eCTDs | June 19, 2013, 2-3:30 PM EDT | Azevedo
April 22nd, 2013 // 1:55 pm @ jmpickett
Antoinette Azevedo – President, e-Submissionssolutions.com
Is your life sciences firm ready for PDUFA and GDUFA mandates for electronic submissions?
On July 9, President Obama signed the FDA Innovation and Safety Act (S3187) which reauthorized PDFUA and MDUFA, implemented the Generic Drug User Fee Act and the Biosimilar User Fee Act. All of these updated regulations have new, far-reaching consequences for all life sciences firms in the United States. Tune into our new webinar on Nov. 28 to learn the details!
Details:
Together these new regulations are called the “UFAs.†Key to PDUFA and GDUFA are mandates for electronic submission – very likely in the eCTD format. In additional MDUFA calls for mandatory Electronic Copy to replace one of the paper copies required for presubmissions and submissions to CDRH.
FDASIA is effective October 1, 2012. Many sponsors inexperienced in the various electronic submission requirements of FDAISA will have great difficulty in meeting the mandates, timelines and quality requirements.
CDER and CBER will be implementing upgrades to the software in their Automatic Submission Receipt (ASR) process that will result in more submissions being rejected immediately due to high severity errors in the content of the eCTD. In addition, the ASR software will for the first time programmatically check for compliance of PDF files. All the PDF errors are rated medium severity which requires corrective action by the sponsor.
Many sponsors inexperienced in the various electronic submission requirements of FDASIA will have great difficulty in meeting the mandates, timelines and quality requirements.
This presentation will describe:
- The mandates and timelines
- Errors inexperienced sponsors must correct in order for their submissions to be reviewed by CDER, CBER, and CDRH
- The impact on sponsors submitting NDA, BLAs, IND, ANDAs, and DMFs will be discussed and proactive steps to take now will be provided.
- CDRH’s Electronic Copy format – while not a rigorous as the eCTD format – will be described and its unique challenges will be addressed.
About Your Presenter:
Antoinette Azevedo founded e-SubmissionsSolutions.com (a California corporation) in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies — all attempting to be better prepared to manage controlled documents and produce electronic INDs/CTAs and drug/biologic registrations.
Ms. Azevedo is the author of  <SGML> Competitors & Markets, Products & Applications, 1994-1998, Antoinette Azevedo and David Henry Goodstein with M. Elizabeth Hunter, European Supplement by Hans Andriese, 1994, InterConsult, Inc. Arlington, MA. Ms. Azevedo has lectured internationally for RAPS, DIA, FDANews, ExpertBriefings, and the Center for Professional Innovation & Education, at vendor user conferences, and for local regulatory affairs professional groups. Ms. Azevedo has been a working member of the Drug Information Association EDM Reference Model Working Group since its inception in February 2008.
Ms. Azevedo was director of West Coast Operations for Liquent from 1997 to 2000. Ms. Azevedo was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North American and Western Europe. Her entire career has been devoted to document management and electronic publishing through a several generations of technologies and architectures, in various industries.  She dedicated her focus to life sciences beginning in 1994. She is experienced with a number of document management systems, publishing systems and toolsets, and a wide array of options for successfully producing electronic submissions. Her experience ranges from developing strategies for document management and electronic publishing, to implementation of fully-validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide.
