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10th Annual Pharmaceutical Regulatory Operations & Submissions Conference

Date: December 1-2, 2021 Venue: Virtual Event Q1 Production’s premier event platform offers a refreshing and unparalleled virtual experience. Thoughtfully designed and customizable networking features foster a sense of collaboration and discussion, allowing attendees to make direct connections. This program offers three half-day modules to maximize retention and engagement.

  • Methods of application and influence of technological advancements
  • AI Integration Automation Possibilities
  • Regulatory operations teams and developing strategic skill sets
  • Bridging the gap between associates at the junior and senior levels
  • Dealing with changes in regulatory requirements and global considerations
  • Keeping up with general industry developments
  • Special considerations regarding emerging markets

Through resource management considerations, you will also look at the construction of submission dossiers and efficiency in optimizing the dossier preparation process, including technology and AI integration. The agenda of the conference includes: 

Time-Saving Strategies to Meet Accelerated Regulatory Submission Timelines

  • Allocating resources and outsourcing decisions
  • Prioritizing speed while retaining quality
  • Best practices for large-scale dossier work

  • Validations
  • Hyperlinking
  • Formatting data
  • Hyperlinking Publishing

  • Using automation to satisfy rising demand
  • Having a positive influence on patients in need

Module 1 of the New eCTD fFr Electronic Submissions To The U.S. FDA

Form 2253 submission for promotional materials 

  • Cross-functional training on regulatory and promotional rules
  • Useful resources for additional learning and outreach
  • Setting up a consistent procedure with the promotions department using FDA advice
  • Forums and websites

The conference aims to establish parameters and educate people regarding: 

  • Vendor selection and validation criteria
  • Training and automation integration for support teams
  • Demonstration of value proposition to offset upfront investment and measuring the gains in productivity due to automation

Hiring Conference

  • A review of attributes regarding hiring of staff that have a high association to success
  • Techniques to expand your search and effectively interview
  • A spotlight on problems related to hiring and training personnel long-term talent acquisition and retention strategy

Who Will Benefit the Most from This Conference?

  • Executives working in pharmaceutical companies who are currently working to implement eCTD 4.0 and newly added promotional submissions requirements
  • Those who want to learn about viable automation solutions for workflow processes
  • Those wanting to develop strategies around global submission timelines

This program will also help you to:

  • Understanding your market and how it affects your submission strategy
  • Take a seat at the early product operations decision-making table
  • Take on compliance as a cross-functional responsibility
  • Regulatory agenda advocacy across the organization

For more information about the event, please visit https://nnw.fm/fz2Pd 

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