2nd eRegulatory Submissions Summit – 2nd eRegulatory Submissions Summit

 

2018 Advisory Board

Featured Speakers

Regulatory submissions landscape has been confronting with many evolving regulatory changes, trends and challenges and it’s important that regulatory professionals properly manage submissions. The regulatory submissions process can quickly become challenging when multiple team members are involved, and it is essential to ensure the quality and consistency of each document included in a submission.

The 2nd eRegulatory Submissions Summit will cover electronic submission processes and protocols for constructing strategies for IDMP, RIM, global and regulatory submissions. This summit will also address regulatory information management experiences and the proposed new standards for the identification of medicinal products and best practices for eCTD submission requirements.

Startdate: 2018-07-10
End Date 2018-07-11

Description: Coming 2018, the 2nd eRegualtory Submissions Summit will address recent updates and guidelines for eCTD and IDMP
Performer: ExL Events
Address : 2nd eRegulatory Submissions Summit


2017 Audience Breakdown by Seniority Level:

Top Five Reasons to Attend

  1. Review EDMS Implementation for eCTD system
  2. Discuss submission management, regulatory project management, agency interactions, and time to market strategies
  3. Understand latest developments in ISO IDMP standards
  4. Gain a better understanding of the complexity of publishing eCTD
  5. Explore global and regulatory eCTD management and requirements

Who Should Attend

This conference is specifically designed for pharma, biotech and med device professionals responsible for:

  • Regulatory Affairs
  • Regulatory Writing/Medical Writing/Publishing/Information/Submissions
  • Document and eRecords Management
  • IDMP
  • Business Operations/Processing
  • Labeling
  • Clinical Trials Management/Data
  • Clinical Data
  • Outsourcing/Clinical Outsourcing/Vendor Management
  • Product Development
  • Quality Assurance/Quality Control

This event is also of interest to:

  • CROs
  • Regulatory Specialists
  • Regulatory Publishing/Regulatory Submission Software Designers