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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
On-demand recording from October 2022.
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.
In this webinar, Regulatory experts working with FDA, EMA, MHRA and Swissmedic will:
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.
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, PhD, RACVeristat
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, PhDSFL, 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, PhDSFL, 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, RACVeristat
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.
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