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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.
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Thursday, 17 February 2022 (8:30 AM - 4:00 PM) Central European Time
There are myriad elements that factor into the development of regulatory strategy. This workshop will provide an analysis of writing of a regulatory plan, emphasizing which key aspects to consider. Several pathways to expedite development will be explored, such as PRIME and adaptive pathways.
Among the topics to be discussed are:
Before 17 January 2022: Member € 555 | Nonmember € 650
After 17 January 2022: Member € 650 | Nonmember € 770
Upon completion of this workshop, participants will be able to:
Welcome, introductions, and overview
Regulatory strategy & regulatory plans, including PRIME
Applying for orphan designation
Maintenance of orphan designation
Review and conclusion
Adriaan Fruijtier, CATS Consultants
Adriaan Fruijtier is an independent regulatory affairs consultant, helping companies develop global regulatory strategy. With a career spanning more than 30 years, he initially studied to be a pharmacist before joining the field of regulatory affairs, where Adriaan specialized in oncology and immunology. He has worked with several companies throughout his career, including Ciba-Geigy B.V., Glaxo B.V., Novartis AG, Micromet AG, and Bayer AG, where he was the head of the oncology group within global regulatory affairs. Additionally, Adriaan spent nearly four years as a project manager at the European Medicines Agency in London. Adriaan has authored more than 15 publications and delivered countless presentations and workshops for the regulatory affairs profession.
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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
Substitutions may be accepted with written approval from RAPS and must be submitted to firstname.lastname@example.org.