Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success

1.0
RAC Credits
Virtual Programs Virtual Programs
Wednesday, 24 August 2022 (11:00 AM) - Wednesday, 24 August 2022 (12:00 PM) Eastern Time (US & Canada)

Submission publishing for investigational drug programs can be prohibitive and costly as health agencies require ever more submission types in electronic formats like eCTD (electronic common technical document). Rapidly changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult. The volume of the documentation can vary significantly and be quite an undertaking for pharmaceutical companies. These challenges demand cutting edge models that offer careful planning, efficiency, cost savings, workforce flexibility and execution of high-end submissions. Having the right partner and level of collaboration is key.

During this webinar, we will show you how Certara regulatory operations specialists were able to partner and collaborate with Advaxis, Inc., a clinical-stage biotech company, devoted to the discovery, development, and commercialization of immunotherapies, to optimize their regulatory operations processes and ensure their timely submissions, mitigating their risk of errors and costly delays. Using this case study, we will share how we were able to turn their challenges into opportunities, achieving major wins.

Learn how we partnered together to achieve all project milestones and regulatory submission success.

Upon the conclusion of this webinar, you will be able to:

  • Understand the complexity, risk, time and cost factors involved in regulatory submissions
  • Learn why selecting the right partner and level of collaboration to navigate unexpected regulatory challenges is key to ensure your submission stays on track
  • Experience first-hand how Certara’s team of regulatory experts defeated regulatory operations challenges, achieving major wins for our biotech client

Registration Fees & Deadlines

Free


Learning Objectives

  • Understand the complexity, risk, time and cost factors involved in regulatory submissions
  • Learn why selecting the right partner and level of collaboration to navigate unexpected regulatory challenges is key to ensure your submission stays on track
  • Experience first-hand how Certara’s team of regulatory experts defeated regulatory operations challenges, achieving major wins for our biotech client

Who Should Attend?

Regulatory Professionals


Speakers:

Dr. Suzanne Minton, Director of Content Strategy, Certara

Dr. Minton has 9 years of corporate marketing experience with expertise in scientific content strategy and communication. Dr. Minton also spent 5 years conducting biomedical research on HIV and cancer. She holds a BS in biology from Duke University and a PhD in pharmacology from the School of Medicine at the University of North Carolina, Chapel Hill.

Jerome Perez, Regulatory Operations Specialist, Certara

Mr. Perez is a skilled editor, with experience in handling different types of documents like journals, books, and financial documents from well-known publishers. He ensures document integrity by checking completeness of task information, prioritize tasks, and ensure quality/timely delivery of project. He is also knowledgeable on troubleshooting (working on corrupted files and software malfunction), communicates with clients on issues, and ensures day-to-day update of monthly team production.

Cancellation Policy

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 raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

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 raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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