This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Clinical Data Disclosure, Transparency and Plain Language Summaries
Mark Your Calendar for Clinical Data Disclosure US 2025!
18 - 19 March, 2025Hybrid Event I Attend Live In-Person or Online

Michele Andrush
Associate Director, Disclosure Services at Certara
Speaker

Profile

With over 30 years of data experience in the pharmaceutical industry, I am a seasoned Project Manager and Senior CT Transparency Specialist. My mission is to ensure the quality, accuracy, and timeliness of clinical data and regulatory submissions for our clients, while adhering to the highest ethical and professional standards.

As a Project Manager, I oversee the planning, execution, and delivery of multiple projects, resources, risks, and stakeholder expectations. As a Senior CT Transparency Specialist, I leverage my skills in business data management, timeline management, and IT project management to review, validate, monitor, and resolve data issues and queries in various web-based data capture platforms, such as RAVE. I also collaborate with internal and external teams to provide data analysis, reporting, and communication.

Agenda Sessions

  • PANEL Outsource vs. Develop Internally: How are Sponsors Meeting Mounting Disclosure Requirements?

    11:00am