Brook White, PMP

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Rising communications leader with proven ability to work effectively with internal and external stakeholders. More than five years experience leading highly visible and complex projects and initiatives with a demonstrated ability to deliver results. Exceptional communication, project management and organization skills. Specialties: Corporate Communications Project Management Technology Implementation Vendor Management Event Management Inbound Marketing Social Media Industry Event Presence

clinical trials drug development fda guidance fda approval cdisc medical monitoring adverse events biotechnology development product safety pharmacovigilance rare disease orphan drugs prescription drug user fee priority review tropical disease target product profile biotechnology pharmaceutical cro contract research organizations research statistics biostatistics sdtm legacy data conversion crf adam protocol development protocol design analgesics analgesia inclusion criteria exclusion criteria regulatory submissions ectd

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Brook White, PMP

Identifying Safety Signals in Pharmaceutical Product Development

Understanding FDA’s Priority Review Voucher System

Get Your Development Program Started on the Right Foot

Optimizing Sponsor/CRO Relationships

Clinical Research Statistics for Non-Statisticians

Post-lock Data Flow: From CRF to FDA

Protocol Design & Development: What You Need to Know to Ensure a Successful Study

Strategies for Analgesic Development and the FDA Guidance for Analgesic Indications

Improving Inclusion/Exclusion Criteria for Clinical Trials

Confused by FDA Guidance on Standardized Study Data for Electronic Submissions?