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Wim Cypers
SVP Regulatory and Safety – ArisGlobal
Lakshmeenarayana Goundalkar (LGG)
Global Director – Professional Services (Regulatory Affairs) – ArisGlobal

Uncover insights and best practices in electronic submission processes to accelerate time-to-market

Webinars

Managing regulatory submissions is a challenge for many pharmaceutical companies as they wrestle with the vast amount of information exchanged within their own department, affiliates and regulatory authorities. The process is often manual, labor-intensive, error-prone and inefficient – all of which can lead to delayed time to market, lost revenue and failed filing processes.

Despite having purchased solutions to help with the submissions process, the last leg remains a highly-manual process. Current systems do not address the electronic submission process to the health authorities, leaving these companies still stuck managing volumes of data manually.

Developing drugs amidst challenging market conditions over an 8-10 year development cycle is just part of the job. Regulatory departments must then work to get their products approved by the respective governing bodies which is ever-evolving in standards (i.e. eCTD, xEVMPD, ISO IDMP) and varies by filing jurisdiction.

Regulatory departments often struggle with transmitting information in the required format while maintaining an audit trail throughout the process. To solve the problem many look to a mix of home-grown solutions, physical media and purpose-built applications which fall short in managing the end-to-end workflow.

Join this webinar where you can learn how to overcome challenges in the submission process which can help accelerate the drug approval process, getting products to market faster and generating a positive ROI sooner.

Register today to uncover insights and best practices in electronic submission processes! Further, for a limited time we're offering all webcast attendees a complimentary consultation that can help you uncover where you are today, where you want to be and what steps you can take to get there.

Presented by

Wim Cypers,
SVP Regulatory and Safety – ArisGlobal

Lakshmeenarayana Goundalkar (LGG),
Global Director – Professional Services (Regulatory Affairs) – ArisGlobal

Learning objectives
  • Understand the challenges faced by regulatory departments in pharma
  • Learn how to overcome those challenges
  • Hear industry leaders and customers share tips for success in the filing process
Audience
  • Regulatory Affairs Manager
  • Regulatory Affairs Director
  • Regulatory Affairs Operations Manager
  • Regulatory Affairs Operations Director
  • Regulatory Affairs IT Manager
  • Regulatory Affairs IT Director
  • Regulatory IT Manager
  • Regulatory IT Director
  • Regulatory Operations Manager
  • Regulatory Operations Director
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