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Regulatory Considerations for Advanced Therapies & RNA-Based Therapeutics

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Thursday, 9 December 2021 (2:00 PM) - Friday, 10 December 2021 (6:00 PM) Central European Time

Advanced therapies are one of the fastest growing sectors in the biopharmaceutical industry. A myriad of new and innovative technologies are being developed to treat human diseases which are often rare or ultra-rare. However, these complex technologies entail regulatory challenges at any stage of the product development. Regulatory requirements for quality, CMC, preclinical and clinical research that may differ by jurisdiation add to the challenges of product development. The first day of the workshop will provide an overview of the regulatory landscape for product development considerations and clinical trial conduct in the European Union and the United States. This overview will include discussion of opportunities to interact with regulators and utilize available regulatory tools. The second day will discuss regulator considerations for specific product types based on case studies.

Pricing Amounts & Deadlines

12 July 2021 –8 November 2021: Early Bird Member €395 | Nonmember €445
9 November 2021-8 December 2021: Regular Member €445 | Nonmember €495

Objectives

  • Learning objectives:
  • Understand the regulatory and development challenges associated with advanced therapies
  • Identify regulatory pathways for optimization of development plans
  • Gain product type specific insights through case study discussion

Workshop leader

Kirsten Messmer, PhD, RAC
Senior Research Analyst
Agency IQ

Kirsten Messmer, PhD, RAC is a Senior Research Analyst and contributes to the research and development of content for Agency IQ. Prior to joining Agency IQ, she was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies. Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK) and a Biology Diplom from the Eberhard-Karls University (Tübingen, Germany). Kirsten also holds a Regulatory Affairs Certification (RAC) in US regulation.

Event Policies

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. Registration fees for this event are nonrefundable. Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of 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.

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.