Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe

RAC Credits
Virtual ProgramsVirtual Programs
Wednesday, 26 October 2022 (1:00 PM) - Wednesday, 26 October 2022 (2:00 PM) Eastern Time (US & Canada)

Sponsors developing drugs/biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for Orphan Drug Designation with the FDA, EMA and other local health authorities. However, due to varying regional and local regulations, ODD applications should be considered from different angles.

Learning Objectives

In this webinar, Regulatory experts working with FDA, EMA, MHRA and Swissmedic will:

  • Share their experiences navigating the requirements, benefits, and nuances of ODD applications
  • Discuss specific examples of ODD applications in various regions

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Registration Fees & Deadlines


Who Should Attend

Sponsors developing drugs/biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for Orphan Drug Designation with the FDA, EMA and other local health authorities.


Mara Holinger

Mara Holinger, PhD, RAC

Mara earned herPhDin Molecular Microbiology from Tufts University School of Medicine and began her career as a lead scientist in anti-cancer research. She now provides pharmaceutical and biotech firms with strategic consulting to prepare their regulatory pathway; toassist in the design of clinical programs; and to assess program gaps and design regulatory road maps.

Additionally, she is an expert in regulatory agency meeting preparation, moderation and logistical support, andservesas an Authorized Regulatory Representative and US Agent. Mara has written, reviewed, or provided oversight for more than 20 Investigational New Drug Applications (INDs), multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and several New Drug Applications.

Julien Gaudias

Julien Gaudias, PhD
SFL, a Veristat Company

Julien is team leader and leads projects from early development to MAA filing and launch of healthcare products. He guides regulatory strategy, oversees preparation and submission of MAA and interacts with Authorities globally for clients’ products.

Julien has extensive experience in pre-submission activities such as CTA, ODD, PIP, scientific advice meetings for medicinal products across a broad range of therapeutic areas. He also provides strategic and operational support for the development and life-cycle management of medical devices, IVDs and combination products, including product classification, preparation of Clinical Evaluation Reports and Technical Documentation, and interactions with Notified Bodies.

In addition, he manages regulatory intelligence projects, preparing high quality documents and customized newsletters for clients.

Julien holds a PhD in Neurobiology from the Center of Molecular Life Sciences of the University of Basel, Switzerland, and obtained an MSc in Neuroscience from the University of Strasbourg, France.

David Berner

David Berner, PhD
SFL, a Veristat Company

David supports a vase variety of regulatory projects including defining strategy, preparation, and review of regulatory documentation to support sponsors in the development, MAA filing and maintenance of healthcare products in Europe. He leads regulatory submissions to Swissmedic and other international Authorities.

David holds a PhD in Neurobiology from the University of Basel, Switzerland, and an MSc in Molecular Biology from the Friedrich Miescher Institute/University of Basel.

Ellen Truitt

Ellen Truitt, RAC

Ellen is a Regulatory Affairs Strategist who supports biopharmaceutical firms looking to advance new drugs intended to treat rare diseases across multiple areas of medicine, as well as numerous products in the oncology space. She began her regulatory career in biotech and pharma at CBR International Corp. in Boulder, Colorado.

Ellen holds a degree in Chemical & Biological Engineering from Colorado State University. In December 2020, Ellen received the RAC – Drugs certification from RAPS.


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.  RAPS is unable to accept cancellations by phone.

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.


For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

Discover more of what matters to you

News »