FDAnews Announces — eCTD Submissions — What You Need to Know To Comply with FDA Requirements Webinar, July 18, 2018

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Drug and biologics filings must comply with the eCTD format by May 5, 2019. Here’s help mastering complex new procedures.

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eCTD Submissions — What You Need to Know To Comply with FDA Requirements:
Best Practices for Pharmaceutical Regulatory Professionals
**An FDAnews Webinar**
July 18, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ectdsubmissions

Drug and biologic submissions are a bear.

The eCTD (Electronic Common Technical Document) submission format for INDs, DMFs, ANDAs, NDA, and BLAs takes time to prepare. Fail to dot an “i" here or cross a “t” there and watch your submission bounce right back, accompanied by a curt RTR (“refuse to receive”).

Luckily, the FDA recently took mercy on drugmakers and extended a second grace period for compliance. Drugmakers now have until May 5, 2019.

Mark the calendar for Wednesday, July 18, when consultant Antoinette Azevedo imparts the knowledge drugmakers need in 90 minutes. Her presentation will cover:

  •     How to avoid an RTR
  •     Implementation roadmap: implementing the technical and organization components for eCTD success
  •     Not spending a fortune: Best practices and options for producing an eCTD economically
  •     Impact on CMO and CRO partners: How the eCTD format may affect them
  •     Impact on other regulatory bodies: How the eCTD format may play in the EU and elsewhere
  •     And much more

This is serious business. The FDA can’t begin a submission review until it confirms the eCTD can be reviewed within PDUFA timelines. That was the reason for the second deadline extension. It would be foolish to expect a third one however.

Meet the Presenter:
Antoinette Azevedo has offered electronic submission consulting since 1995 and eCTD publishing services since 2005. She assists firms of all sizes in all types of submissions on complying with the content and technical requirements of eCTD submissions ¬including: IND, DMF, ANDA, NDA and BLA.

Who Will Benefit:
This presentation is directed at the drug and biologics community. It will be particularly useful to the following:

  •     Medical Officers
  •     Operations Officers
  •     Regulatory Affairs
  •     QA/QR/QC
  •     Information Technology

Webinar Details:
eCTD Submissions — What You Need to Know To Comply with FDA Requirements:
Best Practices for Pharmaceutical Regulatory Professionals
**An FDAnews Webinar**
July 18, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ectdsubmissions

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/ectdsubmissions                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
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