REC Virtual Event: The New Superhero on the Horizon – Are you ready for eCTD v4.0?

This Explorer Class is designed to provide you with a comprehensive understanding of theElectronic Common Technical Document (eCTD) v4.0 submission process. We will start by introducing the 5 key principles that will form the blueprint of your eCTD v4.0 journey. You will learn how to identify and effectively manage the challenges in implementing a new standard and how to navigate the required activities sustainably.

We will then take a deep dive into breaking down eCTD v4.0 into a business understanding to raise awareness across your organization and provide insights on how to leverage eCTD v4.0 for your regulatory strategy’s success.

Finally, we will look at the expectations of the pharmaceutical industry and global health authorities. Our experts will provide you with a comprehensive understanding of the industry’s expectations and how you can leverage eCTD v4.0 to meet them.

This Explorer Class is specifically designed for regulatory affairs professionals who want to stay ahead of the curve and gain the knowledge that can support your organizations compliance. Don’t miss out on this opportunity to learn from the experts and take your eCTD v4.0 journey to the next level.

Registration Fees & Deadlines

Speakers

Anjana Pindoria-Rettenberger
Director Product Strategy, EXTEDO GmbH

Anjana is the Director of Product Strategy at EXTEDO, a company that provides software solutions for life science organizations. She has over 15 years of experience in Regulatory Affairs and special programs, and has been responsible for various aspects, from writing MAA applications to implementing eCTD, XEVMPD, and multiple company integration of global product acquisitions. In her role she plays a critical role in listening to the industry challenges and identifying areas for innovation as well as spearheading the awareness of eCTD v4.0 within the global network. Her role involves scanning the horizon for future changes that could impact how we work today, positioning her niche experience as a strategic expert for organizations seeking to stay ahead of industry trends and regulations.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions