Ayuk Ako
Regulatory Associate at Pivotal
Based in Düsseldorf, Germany
7-day free trial · no credit card
Seniority
Staff
Department
Legal
Location
Düsseldorf
Industry
Research Services
Company size
258
Contact information
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a•••••••@pivotalcr.com
Phone
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Background
About Ayuk Ako
My expertise includes clinical trial application submissions and ensuring compliance with European regulations, particularly the Clinical Trials Regulation (EU) No 536/2014, since its mandatory implementation in January 2023. I specialize in navigating regulatory requirements and ensuring compliance while thriving in multicultural environments. I collect and review documents from trial sites for submission and upload them into the Clinical Trials Information System (CTIS). My primary focus is on Part II submissions, but I have also handled Part I submissions independently in a single-country trials. Additionally, I adapt informed consent forms (ICFs) and create various regulatory documents to meet country-specific requirements. With strong analytical, communication, and time-management skills, I ensure high-quality regulatory submissions and contribute to the smooth execution of clinical trials.
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