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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Start-up companies within the MedTech industry often focus on innovative product development and short timelines for bringing medical devices to market, frequently not factoring in regulatory requirements upfront. However, understanding regulatory affairs and the regulatory approval process is an essential component for success and staying within budget.
This workshop will provide a fundamental overview of regulatory requirements in Europe and the U.S. However, the focus will be regulatory strategies that might suit companies and acquiring regulatory knowledge.
March 1, 2023 — May 20, 2023: Early Bird $665 Member | $785 Nonmember
May 21, 2023 — June 20, 2023: Regular $785 Member | $920 Nonmember
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Regulatory professionals, especially those at startups and managers of start-up companies.
Instructors:
Jennifer NeffDVM, PhD, MBA, RAC, Chair
Dr. Jennifer Neff has worked in the areas of medical devices, pharmaceuticals, and biotechnology for more than 16 years and recently joined the Bitop AG as head of medical devices & principal consultant regulatory, clinical affairs & QM. Previously, she held regulatory affairs and clinical affairs positions at Sartorius Stedim Biotech, Bess AG, Bayer Health Care, Parexel Consulting, Berlin Heart, and Biotronik. Her experiences include a broad range of medical devices, such as tracheobronchial stents, ventricular assist devices, tumor markers, and substance-based. Prior to joining the industry, Neff was a practicing veterinarian. She is chair of the European Council of RAPS and board member of the RAPS’ German Chapter.
Susana De Azevedo WaeschVice President of quality management and regulatory affairs
Susana de Azevedo Wäsch is vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 25 years of experience in medical devices, pharmaceuticals, and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the U.S. Center for Advanced Research in Biotechnology. She is also a director of the RAPS EU Board.
RAPS HQ5635 Fishers LaneTerrace LevelRockville, MD 20852
Parking:
Parking will be free at RAPS HQ with a validated ticket. Please make sure to bring your parking ticket to registration to validate parking. Overnight parking is not allowed.
Local Hotels:
Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr 1750 Rockville Pike Rockville, Maryland, 20852-1699, USA Telephone: (301) 468-1100 Hotel Website Distance to RAPS HQ: .8 miles Directions to RAPS HQ
EVEN Hotel Rockville 1775 Rockville Pike Rockville, MD 20852 Telephone: (301) 881-3836 Hotel Website Distance to RAPS HQ: .7 miles Directions to RAPS HQ
RAPS has initiated a Be Well policy, with consent required during the registration process. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while onsite at RAPS HQ, you will reconsider your participation at the event.
To ensure your personal safety and comfort during this event, RAPS is committed to robust and transparent communications during the event. We encourage all participants to monitor RAPS social media channels and download the conference app to their mobile devices to receive up-to-the-minute updates.
All cancellation requests must be submitted in writing to support@raps.org. Cancellation requests received by 6 June 2023 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 6 June 2023 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.
Paid substitution requests received, and approved in writing by RAPS before the start of the event, will be honored. To transfer a registration, email support@raps.org with the event title, original registrant’s name, and substitute’s contact information.
RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.
By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution.