TOPIC: What is unique about Europe compared with the U.S., including centralized, national and Notified Body routes
TOPIC DESCRIPTION: While the U.S. system generally routes companies through a single federal authority, Europe requires a different strategic view. For medicinal products, companies may interact with the EMA or with national competent authorities, depending on product type and route. For products that are not biologics, complex products or advanced technologies, some regulatory routes may be managed through one or more individual European countries rather than only through a centralized process. For medical devices, the difference is even more significant: in the U.S. the pathway is handled through one authority, while in Europe conformity assessment is performed by private Notified Bodies, with many different bodies operating across the region. The meeting will explain what is easier, what is more complex and what is simply different, and why companies planning development should consider European requirements early, even when the first planned submission is in the U.S. Early planning can prevent duplicated work and avoid delays when the company later expands to Europe.
SPEAKER: Rivka Zaibel
SPEAKER BIOGRAPHY: Rivka Zaibel is President and Founder of ADRES, bringing more than 36 years of expertise in biopharmaceutical and biotechnology development, including 20 years focused on regulatory and quality management of drugs, biologics, medical devices and combination products. She has extensive experience leading multidisciplinary programs and coordinating internal and external activities across the development lifecycle, from lead compound identification through CMC, preclinical and clinical development, and product registration.
Rivka remains actively engaged with regulatory requirements in the U.S. and Europe and has participated in numerous meetings with regulatory authorities to advance development programs. She also mentors initiatives such as SPARK, Biodesign and EIT Health, and serves as a lecturer in the Master's program for Development and Regulation of Medical Technologies at Tel Aviv University.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification/ continuing education from the following organizations:
| 1.5 pts |
RAC recertification from RAPS |
| 1.5 CEUs |
CCRP recertification from SOCRA |
| 1.5 CEUs |
CIP recertification from PRIM&R |
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This webinar will be recorded.